RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-N4-XX-XXX-XXX
FDA Device Recall #Z-0998-2023 - Class II, December 20, 2022
Recall Summary
| Recall Number | Z-0998-2023 |
| Classification | Class II - Moderate risk |
| Date Initiated | December 20, 2022 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Bolton Medical Inc. |
| Location | Sunrise, FL |
| Product Type | Devices |
| Quantity | 640 units |
Product Description
RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-N4-XX-XXX-XXX
Reason for Recall
The product may be shorter than packaging indicates
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of UK, France, Germany, Italy, Netherlands, Chile, Japan, and China.
Lot / Code Information
UDIUDI/DI 00843576100954, REF 28-N4-22-159-22S, Lot Numbers: B210719245, B210619174; UDI/DI 00843576100831, REF 28-N4-24-099-24S, Lot Numbers: B220323028, B211222140; UDI/DI 00843576150423, REF 28-N4-24-099-24U, Lot Numbers: 2204210157, 2204210158, 2208230256, 2208250035; UDI/DI 00843576100961, REF 28-N4-24-159-24S, Lot Numbers: B220104035, B220824113, B210612293, B220201173; UDI/DI 00843576150553, REF 28-N4-24-159-24U, Lot Numbers: 2202090215, 2202090293; UDI/DI 00843576101227, REF 28-N4-24-259-24S, Lot Numbers: B220210257, B220210257; UDI/DI 00843576150812, REF 28-N4-24-259-24U, Lot Numbers: 2210110048, 2210110049, 2210100193; UDI/DI 00843576100848, REF 28-N4-26-104-26S, Lot Numbers: B220226088, B220414055; UDI/DI 00843576150430, REF 28-N4-26-104-26U, Lot Numbers: 2110070047, 2202020135, 2202010164, 2112210201, 2202120154, 2202260085, 2204140202; UDI/DI 00843576100978, REF 28-N4-26-164-26S, Lot Numbers: B220316171, B210927313, B210602367, B220303176, B220316275, B220204220, B220210181, B220210141, B211215127, B220203121; UDI/DI 00843576150560, REF 28-N4-26-164-26U, Lot Numbers: 2110130276, 2203030136, 2203040029, 2206140190, 2202280430, 2203030197, 2202020185, 2202090218, 2202100235; UDI/DI 00843576150690, REF 28-N4-26-204-26U, Lot Numbers: 2201150114, 2204150063, 2206130239; UDI/DI 00843576100855, REF 28-N4-28-104-28S, Lot Numbers: B220323030, B220323295, B221024139, B221026118, B221024275; UDI/DI 00843576150447, REF 28-N4-28-104-28U, Lot Numbers: 2108090034, 2206140194, 2112170035, 2202100079, 2202110166, 2202160141; UDI/DI 00843576150935, REF 28-N4-28-164-24U, Lot Numbers: 2202160143, 2202160143, 220614019; UDI/DI 00843576100985, REF 28-N4-28-164-28S, Lot Numbers: 2202150157, B210713325, B211019291, B211218042, B211217126, B211228051, B211228183, B211019294, B220302187, B220308234, B220308196, B220315291, B220315290, B220316085, B220224046, B211215130, B220211180, B220215104, B220215116, B211218039, B220215116; UDI/DI 00843576150577, REF 28-N4-28-164-28U, Lot Numbers: 2202140139, 2203160088, 2203110300, 2208190099, 2203110300, 2208230038; UDI/DI 00843576101449, REF 28-N4-28-204-24S, Lot Numbers: B220216144; UDI/DI 00843576151031, REF 28-N4-28-204-24U, Lot Numbers: 2203040078, 2203040076; UDI/DI 00843576101111, REF 28-N4-28-204-28S, Lot Numbers: B220222108, B220222103, B220222101, B220216186, B220315302; UDI/DI 00843576150706, REF 28-N4-28-204-28U, Lot Numbers: 2203140261, 2210260120; UDI/DI 00843576100862, REF 28-N4-30-104-30S, Lot Numbers: B220222073, B220613221, B220316226, UDI/DI 00843576150454, REF 28-N4-30-104-30U, Lot Numbers: 2202150087, 2108110152, 2108110159, 2108140005, 2108110132, 2202160183, 2202150087, 2202280426, 2110180211, 2206130118, 2206130220, 2206130222, 2108240015; UDI/DI 00843576101357, REF 28-N4-30-164-26S, Lot Numbers: B220316227, B220224140, B220224216, B220223287, B220224044, B220222297, B220225423; UDI/DI 00843576150942, REF 28-N4-30-164-26U, Lot Numbers: 2203040072, 2110130019, 2110130017, 2203040073, 2110190312, 2208250041, 2112220164, 2201210010, 2202050219, 2202030151, 2210110302, 2205210093; UDI/DI 00843576100992, REF 28-N4-30-164-30S, Lot Numbers: B220324178, B220324178, B220324163, B211012014; UDI/DI 00843576150584, REF 28-N4-30-164-30U, Lot Numbers: 2203010234, 2202230316, 2202250014, 2202280425, 2202180529, 2202220074, 2202220072, 2202220069, 2202180529, 2202220074, 2202220072, 2202220069, 2203020201, 2206130228, 2202140234; UDI/DI 00843576101456, REF 28-N4-30-209-26S, Lot Numbers: B220316255; UDI/DI 00843576151048, REF 28-N4-30-209-26U, Lot Numbers: 2112140027, 2112130022, 2202160146, 2202150163, 2202160145, 2203160257, 2208250012, 2201180076, 2203160257, 2208240034; UDI/DI 00843576101128, REF 28-N4-30-209-30S, Lot Numbers: B220326008, B220222333; UDI/DI 00843576150713, REF 28-N4-30-209-30U, Lot Numbers: 2203160252, 2202220110, 2202220113, 2203160253, 2112210090, 2201040111, 2201180074, 2202140257, 2202100239, 2202110347; UDI/DI 00843576101258, REF 28-N4-30-259-30S, Lot Numbers: B220215153; UDI/DI 00843576100879, REF 28-N4-32-104-32S, Lot Numbers: B220216231, B221021262, B220324319; UDI/DI 00843576150461, REF 28-N4-32-104-32U, Lot Numbers: 2108120046, 2107140315, 2202180555, 2202160240, 2202170062, 2107260368, 2107240008, 2112170233, 2202190002, 2202180531, 2202180555, 2202190002, 2107260364, 2112270017, 2202040221; UDI/DI 00843576101364, REF 28-N4-32-164-28S, Lot Numbers: B220324327, B220822175, B220824051, B220823128, B220824185, B220824144, B211216067, B220325018, B220324175, B220324176, B220825153, B211215259, B220324175, B220324176, B220823156, B220823157; UDI/DI 00843576150959, REF 28-N4-32-164-28U, Lot Numbers: 2203230306, 2210210006, 2210260127, 2202230291, 2202230295; UDI/DI 00843576101005, REF 28-N4-32-164-32S, Lot Numbers: B220325138, B220323296, B220323298, B220613231, B211211183, B211214172, B211211162; UDI/DI 00843576150591, REF 28-N4-32-164-32U, Lot Numbers: 2203250141, 2203230297, 2110060132, 2203030284, 2208240048, 2208250009, 2210250032, 2203080200, 2112110095, 2204010186, 2210250296; UDI/DI 00843576101463, REF 28-N4-32-209-28S, Lot Numbers: B220323320; UDI/DI 00843576151055, REF 28-N4-32-209-28U, Lot Numbers: 2202020166, 2202180572, 2112150321, 2112110166, 2112110165, 2202280418, 2205250253; UDI/DI 00843576101135, REF 28-N4-32-209-32S, Lot Numbers: B220324197, B211214116, B220222117, B220222117; UDI/DI 00843576150720, REF 28-N4-32-209-32U, Lot Numbers: 2203230299, 2204090207, 2112140173, 2208250166, 2208230272; UDI/DI 00843576101562, REF 28-N4-32-259-28S, Lot Numbers: B211012003; UDI/DI 00843576151154, REF 28-N4-32-259-28U, Lot Numbers: 2206130123; UDI/DI 00843576150478, REF 28-N4-34-109-34U, Lot Numbers: 2203080004, 2203100247, 2108210088, 2109030355, 2203080007, 2112210087, 2112210085, 2210110299, 2112110082, 2203080003, 2206130241; UDI/DI 00843576101371, REF 28-N4-34-154-30S, Lot Numbers: B210608025, B211213134, B211214113, B211028048, B211101323, B211220050, B211221096, B220314244; UDI/DI 00843576150966, REF 28-N4-34-154-30U, Lot Numbers: 2203040077, 2203040075, 2204040345, 2110040246, 2202240217, 2204120411, 2112180054, 2112200048, 2210120224, 2202050011; UDI/DI 00843576101012, REF 28-N4-34-154-34S, Lot Numbers: B211221131, B211220039, B210610038; UDI/DI 00843576150607, REF 28-N4-34-154-34U, Lot Numbers: 2203080204, 2202220094, 2109070357, 2109040003, 2108280016, 2107300166, 2107300158, 2202220127, 2202220104, 2202220129, 2109040002, 2112200021, 2112210095, 2201070130, 2202260034, 2202220096, 2202220075, 2202220079, 2202220138, 2202220102, 2201070146, 2202220075, 2202220138, B220315087; UDI/DI 00843576151062, REF 28-N4-34-209-30U, Lot Numbers: 2205250147, 2112200052, 2201190027, 2201180135, 2201310004; UDI/DI 00843576101142, REF 28-N4-34-209-34S, Lot Numbers: B211214294, B220324009, B220324165, B220324181, B220326025, B220324181, B211214174, B220325013, B220329320; UDI/DI 00843576150737, REF 28-N4-34-209-34U, Lot Numbers: 2210260199, 2210260201, 2210260198, 2210260200, 2210260126, 2210260197, 2210260207, 2203090075, 2203100243, 2203250143, 2206140097; UDI/DI 00843576170155, REF 28-N4-34-210-44U, Lot Numbers: 2208240124; UDI/DI 00843576101272, REF 28-N4-34-259-34S, Lot Numbers: B211222139; UDI/DI 00843576150867, REF 28-N4-34-259-34U, Lot Numbers: 2210100114; UDI/DI 00843576100893, REF 28-N4-36-109-36S, Lot Numbers: B211213218, B221007301, B211215203, B220226036, B220228230, B220228434, B220322215, UDI/DI 00843576150485, REF 28-N4-36-109-36U, Lot Numbers: 2107150330, 2107210144, 2107150333, 2112160106; UDI/DI 00843576101388, REF 28-N4-36-154-32S, Lot Numbers: B220825195, B220316259, B220822023, B211221094; UDI/DI 00843576150973, REF 28-N4-36-154-32U, Lot Numbers: 2202140171, 2203100002, 2110060302, 2202170251, 2203080225, 2203080362, 2203030299, 2112100338, 2112150158, 2112150159, 2202150132, 2202140062, 2201200119, 2202140062; UDI/DI 00843576150973, REF 28-N4-36-154-32U, Lot Numbers: 2202120091; UDI/DI 00843576101029, REF 28-N4-36-154-36S, Lot Numbers: B220324164, B211217046, B220825165, B211217043, B220420031, B220415060, B220420032, B220419247; UDI/DI 00843576150614, REF 28-N4-36-154-36U, Lot Numbers: 2202140142, 2202140222, 2202140142, 2202120084, 2108040300, 2108100279, 2110120294, 2202250085, 2204200029, 2204190245, 2204140198, 2204180291, 2201200081; UDI/DI 00843576101487, REF 28-N4-36-199-32S, Lot Numbers: B220420141, B220824035, B220823266, B211217230, B220420142; UDI/DI 00843576151079, REF 28-N4-36-199-32U, Lot Numbers: 2112140115, 2202160005, 2202160147, 2202150173, 2202160062, 2202160192, 2202190003, 2202220342, 2201180071, 2201210202, 2202150173, 2202160192, 2202190003, 2202160147, 2201310240; UDI/DI 00843576101159, REF 28-N4-36-199-36S, Lot Numbers: B220325145, B220316278, B220614146, B220812095, B220824139; UDI/DI 00843576150744, REF 28-N4-36-199-36U, Lot Numbers: 2202160190, 2202170035, 2203030285, 2203250159, 2204200134, 2203080251, 2203020257, 2203040068, 2203160254, 2203160313, 2112180048, 2112200054, 2112200042, 2202120166, 2204200137, 2204200132, 2202120166, 2202170035; UDI/DI 00843576151178, REF 28-N4-36-259-32U, Lot Numbers: 2102240015, 2201170287; UDI/DI 00843576101289, REF 28-N4-36-259-36S, Lot Numbers: B220412367, B220226086; UDI/DI 00843576150492, REF 28-N4-38-109-38U, Lot Numbers: 2201290084, 2107220127, 2112010077, 2107220126; UDI/DI 00843576101395, REF 28-N4-38-154-34S, Lot Numbers: B220329299, B220418293; UDI/DI 00843576150980, REF 28-N4-38-154-34U, Lot Numbers: 2201210011, 2204210129, 2204060407, 2204220290, 2112130021, 2201290305; UDI/DI 00843576101036, REF 28-N4-38-154-38S, Lot Numbers: B220329318, B220420115, B211215133, B211215143, B211215134, B211227031, B220823037; UDI/DI 00843576150621, REF 28-N4-38-154-38U, Lot Numbers: 2110130259, 2201260405, 2110130263, 2110130261, 2110130262, 2204210143, 2208230039, 2208250172, 2201200092, 2201200099, 2201210068, 2201260344, 2205060274; UDI/DI 00843576101494, REF 28-N4-38-199-34S, Lot Numbers: B220414211; UDI/DI 00843576151086, REF 28-N4-38-199-34U, Lot Numbers: 2203030169, 2210260129, 2206130122, 2112220144, 2112150208, 2201180083, 2201180079, 2201180132, 2201210298; UDI/DI 00843576101166, REF 28-N4-38-199-38S, Lot Numbers: B220411209, B220823257, B220614191, B220823260; UDI/DI 00843576150751, REF 28-N4-38-199-38U, Lot Numbers: 2203080257, 2201210100, 2201210117, 2201210186, 2201210057, 2201270226, 2208230274, 2208230124, 2208240033, 2208230258, 2208220167, 2208250078, 2208240184, 2208250152, 2201210157, 2201250164; UDI/DI 00843576101593, REF 28-N4-38-259-34S, Lot Numbers: B220315384; UDI/DI 00843576151185, REF 28-N4-38-259-34U, Lot Numbers: 2108260329; UDI/DI 00843576101296, REF 28-N4-38-259-38S, Lot Numbers: B210609044, B211214297, B220824031; UDI/DI 00843576150881, REF 28-N4-38-259-38U, Lot Numbers: 2203080242, 2108040320, 2204110222, 2204200258; UDI/DI 00843576100916, REF 28-N4-40-114-40S, Lot Numbers: B211220015; UDI/DI 00843576101401, REF 28-N4-40-154-36S, Lot Numbers: B220212187, B211218056, B211221089, B220214225, B220328369; UDI/DI 00843576150997, REF 28-N4-40-154-36U, Lot Numbers: 2203240199, 2203250146, 2201210024, 2201210021, 2201210027, 2201310002; UDI/DI 00843576101043, REF 28-N4-40-154-40S, Lot Numbers: B220328261, B220329007, B220328341, B220124254, B211227044, B220301024; UDI/DI 00843576150638, REF 28-N4-40-154-40U, Lot Numbers: 2201200112, 2205180204, 2204220151, 2204210111, 2204200034, 2204090201, 2201180080, 2201210330, 2203010010, 2204230122, 2201250163; UDI/DI 00843576101500, REF 28-N4-40-204-36S, Lot Numbers: B220324328, B220316279; UDI/DI 00843576151093, REF 28-N4-40-204-36U, Lot Numbers: 2112130223, 2210260205, 2204220084, 2201310010, 2201280055, 2204200217, 2204220085, 2204200140, 2210120145, 2210260204, 2201220095; UDI/DI 00843576101173, REF 28-N4-40-204-40S, Lot Numbers: B220328304, B220328305, B220613305; UDI/DI 00843576150768, REF 28-N4-40-204-40U, Lot Numbers: 2203030296, 2204200040, 2203080217, 2201150117, 2201220082, 2204210012, 2204210125, 2201220134, 2201280513, 2201270355, 2204200039; UDI/DI 00843576101609, REF 28-N4-40-259-36S, Lot Numbers: B220824044, B220824036; UDI/DI 00843576151192, REF 28-N4-40-259-36U, Lot Numbers: 2204200222; UDI/DI 00843576150898, REF 28-N4-40-259-40U, Lot Numbers: 2204190260; UDI/DI 00843576100923, REF 28-N4-42-114-42S, Lot Numbers: B220321140, B220404334; UDI/DI 00843576150515, REF 28-N4-42-114-42U, Lot Numbers: 2203160312, 2204040417, 2203160251, 2203220286; UDI/DI 00843576101418, REF 28-N4-42-159-38S, Lot Numbers: B211012054, B220325029, B211012055, B220321152, B211012056, B220328370, B220404378, B220402106; UDI/DI 00843576101050, REF 28-N4-42-159-42S, Lot Numbers: B220316277, B220406080, B220402047, B211009014, B220414056, B220406068; UDI/DI 00843576150645, REF 28-N4-42-159-42U, Lot Numbers: 2110140278, 2110140277, 2110140280, 2204210144, 2204210162, 2204210161, 2201310162, 2201310237, 2202010186, 2204210146, 2204200119; UDI/DI 00843576151109, REF 28-N4-42-204-38U, Lot Numbers: 2108140131, B220322396, 2107280013; UDI/DI 00843576100930, REF 28-N4-44-114-44S, Lot Numbers: B220222271, B220222274; UDI/DI 00843576150522, REF 28-N4-44-114-44U, Lot Numbers: 2206140189, 2202220098; UDI/DI 00843576101425, REF 28-N4-44-164-40S, Lot Numbers: B220324203; UDI/DI 00843576101067, REF 28-N4-44-164-44S, Lot Numbers: B211011231, B211006018; UDI/DI 00843576150652, REF 28-N4-44-164-44U, Lot Numbers: 2202030148, 2202040349, 2202040352, 2202040347, 2208190235; UDI/DI 00843576101524, REF 28-N4-44-209-40S, Lot Numbers: B220824003; UDI/DI 00843576151116, REF 28-N4-44-209-40U, Lot Numbers: 2202020151, 2206140102, 2208250013, 2202050009, 2202100078; UDI/DI 00843576101197, REF 28-N4-44-209-44S, Lot Numbers: B220328360, B220614195, B220328357, B220328351; UDI/DI 00843576150782, REF 28-N4-44-209-44U, Lot Numbers: 2203030286, 2107300026; UDI/DI 00843576101432, REF 28-N4-46-164-42S, Lot Numbers: B220328378, B221021036, B220325147; UDI/DI 00843576151024, REF 28-N4-46-164-42U, Lot Numbers: 2110050160, 2202040376; UDI/DI 00843576101531, REF 28-N4-46-209-42S, Lot Numbers: B220329306, B221025297, B220326018; UDI/DI 00843576151123, REF 28-N4-46-209-42U, Lot Numbers: 2110180197, 2202040375; UDI/DI 00843576101203, REF 28-N4-46-209-46S, Lot Numbers: B220329254, B220322230; UDI/DI 00843576150799, REF 28-N4-46-209-46U, Lot Numbers: 2110090005, 2202100283, 2202010117; UDI/DI 00843576151222, REF 28-N4-46-259-42U, Lot Numbers: 2107200052;
Other Recalls from Bolton Medical Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2160-2026 | Class I | RelayPro Thoracic Stent-Graft System (various s... | Apr 22, 2026 |
| Z-1383-2024 | Class II | RELAY PRO Thoracic Stent-Graft System, containi... | Feb 22, 2024 |
| Z-1689-2023 | Class II | The TREO ABDOMINAL STENT-GRAFT SYSTEM (TREO) co... | May 3, 2023 |
| Z-0997-2023 | Class II | RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-... | Dec 20, 2022 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic, removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency, Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.