Model Number S722, ALTRUA 2 DR EL Pacemaker
FDA Device Recall #Z-0100-2026 - Class I, August 20, 2025
Recall Summary
| Recall Number | Z-0100-2026 |
| Classification | Class I - Serious risk |
| Date Initiated | August 20, 2025 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Boston Scientific Corporation |
| Location | Saint Paul, MN |
| Product Type | Devices |
| Quantity | 3376 units |
Product Description
Model Number S722, ALTRUA 2 DR EL Pacemaker
Reason for Recall
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
Distribution Pattern
Worldwide
Lot / Code Information
GTIN 00802526559372, Serial numbers: 100037, 100039, 100040, 100041, 100042, 100052, 100066, 100067, 100068, 100070, 100071, 100072, 100073, 100075, 100076, 100077, 100080, 100081, 700442, 700445, 700447, 700448, 700452, 700455, 700470, 700486, 700541, 700554, 700568, 700569, 700589, 700636, 700666, 702537, 702548, 702681, 702731, 702760, 702763, 702766, 702767, 702773, 702775, 702900, 702902, 702903, 702911, 702930, 704458, 704459, 704521, 707526, 707529, 708164, 708180, 708183, 708252, 708264, 708427. GTIN 00802526576515, Serial numbers: 100002, 100003, 100004, 100006, 100008, 100009, 100010, 100011, 100012, 100014, 100015, 100016, 100017, 100018, 100019, 100020, 100021, 100022, 100023, 100024, 100025, 100026, 100027, 100029, 100030, 100031, 100032, 100033, 100034, 100035, 100036, 100038, 100044, 100046, 100047, 100048, 100049, 100050, 100053, 100054, 100055, 100056, 100057, 100059, 100060, 100061, 100064, 100078, 100082, 100083, 100084, 100086, 100088, 100089, 100090, 100091, 100092, 100093, 100094, 100095, 100096, 700001, 700002, 700003, 700004, 700005, 700006, 700007, 700008, 700009, 700011, 700012, 700013, 700014, 700016, 700017, 700018, 700019, 700020, 700031, 700032, 700033, 700034, 700035, 700036, 700037, 700039, 700040, 700041, 700042, 700043, 700044, 700045, 700046, 700047, 700048, 700049, 700050, 700052, 700053, 700054, 700055, 700056, 700057, 700058, 700059, 700060, 700061, 700062, 700063, 700064, 700065, 700066, 700067, 700068, 700069, 700070, 700071, 700072, 700073, 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GTIN 00802526578113, Serial numbers: 700133, 700155, 700201, 700207, 700210, 700211, 700216, 700226, 700229, 700236, 700238, 700240, 700246, 700255, 700258, 700278, 700281, 700286, 700287, 700300, 700311, 700317, 700320, 700323, 700324, 700325, 700326, 700327, 700328, 700329, 700330, 700331, 700332, 700333, 700334, 700335, 700411, 700414, 700415, 700417, 700421, 700422, 700423, 700424, 700425, 700427, 700429, 700432, 700433, 700435, 700438, 700440, 700444, 700449, 700451, 700456, 700467, 700468, 700483, 700484, 700493, 700508, 700538, 700549, 700622, 700661, 700664, 700679, 700721, 700724, 700731, 700781, 700782, 700789, 700793, 700799, 700806, 700810, 700816, 700825, 700830, 700835, 700841, 700844, 700853, 700856, 700857, 700880, 701041, 701046, 701079, 701082, 701103, 701109, 701115, 701118, 701119, 701121, 701124, 701129, 701131, 701133, 701134, 701136, 701139, 701140, 701141, 701142, 701146, 701148, 701151, 701154, 701158, 701159, 701162, 701164, 701165, 701169, 701170, 701171, 701175, 701176, 701178, 701183, 701195, 701205, 701214, 701215, 701222, 701234, 701238, 701241, 701246, 701249, 701250, 701252, 701253, 701254, 701256, 701258, 701262, 701264, 701266, 701268, 701269, 701270, 701271, 701273, 701275, 701279, 701280, 701287, 701290, 701292, 701296, 701300, 701312, 701313, 701314, 701315, 701316, 701317, 701318, 701319, 701321, 701326, 701327, 701329, 701330, 701331, 701333, 701335, 701336, 701337, 701338, 701341, 701342, 701343, 701344, 701345, 701346, 701347, 701348, 701349, 701350, 701351, 701352, 701353, 701354, 701355, 701356, 701357, 701358, 701359, 701360, 701361, 701362, 701363, 701364, 701365, 701366, 701367, 701368, 701369, 701370, 701371, 701372, 701373, 701374, 701375, 701376, 701377, 701378, 701379, 701380, 701381, 701439, 701449, 701455, 701463, 701492, 701499, 701507, 701510, 701524, 701533, 701534, 701535, 701536, 701537, 701538, 701539, 701540, 701541, 701545, 701546, 701548, 701550, 701552, 701553, 701555, 701556, 701557, 701559, 701562, 701563, 701565, 701566, 701567, 701568, 701569, 701570, 701573, 701574, 701576, 701577, 701578, 701581, 701684, 701687, 701691, 701695, 701701, 701720, 701721, 701730, 701734, 701740, 701742, 701744, 701748, 701749, 701756, 701759, 701762, 701763, 701765, 701771, 701772, 701773, 701774, 701775, 701776, 701779, 701782, 701783, 701785, 701786, 701787, 701789, 701791, 701792, 701794, 701795, 701796, 701797, 701798, 701799, 701800, 701802, 701803, 701807, 701811, 701812, 701815, 701816, 701820, 701821, 701846, 701869, 701880, 702043, 702044, 702045, 702053, 702062, 702065, 702066, 702076, 702084, 702086, 702087, 702093, 702094, 702100, 702109, 702112, 702113, 702117, 702119, 702126, 702128, 702141, 702145, 702147, 702149, 702163, 702180, 702184, 702185, 702189.
Other Recalls from Boston Scientific Corporation
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2962-2026 | Class II | Suture Cinch Long 1pk. Endoscopic tissue app... | Jul 14, 2026 |
| Z-2961-2026 | Class II | OverStitch Suture Cinch, 1pk. Endoscopic tissue... | Jul 14, 2026 |
| Z-2977-2026 | Class I | Boston Scientific ENROUTE Transcarotid Neuropro... | Jul 9, 2026 |
| Z-2978-2026 | Class I | Boston Scientific ENROUTE Transcarotid Neuropro... | Jul 9, 2026 |
| Z-2838-2026 | Class II | Radial Jaw 4 Standard Capacity Biopsy Forceps w... | Jun 30, 2026 |
Frequently Asked Questions
A software recall means the device's embedded software or firmware has a defect that could affect its performance or safety. Many software recalls are corrected through firmware updates that can be applied without physically replacing the device. For implantable devices, the update may be delivered wirelessly during a routine clinic visit. For external devices, the manufacturer may provide updated software files or replacement units. Contact your healthcare provider to determine whether your specific device and software version are affected and what action is recommended.
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.