Merit Maestro Microcatheter, Reference Numbers: 28MC2111045/B, 28MC21110ST/B, 28MC2113045/B, ...
FDA Device Recall #Z-0627-2024 — Class II — November 6, 2023
Recall Summary
| Recall Number | Z-0627-2024 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 6, 2023 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Merit Medical Systems, Inc. |
| Location | South Jordan, UT |
| Product Type | Devices |
| Quantity | 717 units |
Product Description
Merit Maestro Microcatheter, Reference Numbers: 28MC2111045/B, 28MC21110ST/B, 28MC2113045/B, 28MC21130SN/CNB, 28MC21130ST/B, 28MC2115045/B, 28MC2115045/C, 28MC21150SN/B, 28MC21150ST/B, 28MC2411045/D, 28MC24110SN/D, 28MC24110ST/D, 28MC2413045/D, 28MC24130SN/F, 28MC24130ST/D, 28MC24130ST-W/A, 28MC2415045/D, 28MC24150ST/D, 28MC24150ST/F, 28MC28110ST/D, 28MC2813045/D, 28MC28130SN/D, 28MC28130SN/F, 28MC28130ST/D, 28MC28150SN/D, 28MC28150SN/F, 29MC2911045/D, 29MC29130SN/F, 29MC29130ST/D, 29MC29150ST/CNB, 29MC29150ST/D, CE 2797, STERILEEO, Rx ONLY
Reason for Recall
The sterility of microcatheter and infusion system devices cannot be guaranteed.
Distribution Pattern
Worldwide - US Nationwide distribution in the states of AL, AZ, CA, CO, CT, FL, IA, IL, IN, KS, MA, MD, MN, MO, NH, NJ, NSW, NV, NY, UT, WI and the countries of Argentina, Australia, Belgium, China, France, Germany, Guam, Hong Kong, Italy, Mexico, Netherlands, Switzerland.
Lot / Code Information
Ref:28MC2111045/B - Lot # H2775120 - UDI: 00884450335215; Ref: 28MC21110ST/B- Lot # H2750697 and H2775121 - UDI: 00884450335239; Ref:28MC2113045/B- Lot # H2750699, H2763805, H2775122 - UDI: 00884450335246; Ref:28MC21130SN/CNB- Lot # H2747446-UDI:00884450335253; Ref:28MC21130ST/B- Lot # H2750708 - UDI: 00884450335260 Ref:28MC2115045/B- Lot # H2750484 - UDI: 00884450335277 Ref:28MC2115045/C- Lot # H2750714 - UDI: 00884450442456 Ref:28MC21150SN/B- Lot # H2750715 and H2769214 00884450335284 Ref:28MC21150ST/B- Lot # H2750719 - UDI: 00884450335291 Ref:28MC2411045/D- Lot # H2750721 and H2769962 - UDI: 00884450357903 Ref:28MC24110SN/D- Lot # H2750518 - UDI: 00884450357910 Ref:28MC24110ST/D- Lot # H2750733 - UDI: 00884450357927 Ref:28MC2413045/D- Lot # H2766010 - UDI: 00884450357934 Ref:28MC24130SN/F- Lot # H2750372 00884450358207 Ref:28MC24130ST/D- Lot # H2750747 and H2779460 UDI: 00884450357958 Ref:28MC24130ST-W/A- Lot # H2777603 00884450324592 Ref:28MC2415045/D- Lot # H2750756, H2766011, H2769993, UDI: 00884450357965 Ref:28MC24150ST/D- Lot # H2750768-UDI: 00884450357989 Ref:28MC24150ST/F- Lot # H2749681-UDI: 00884450358245 Ref:28MC28110ST/D- Lot # H2770003- UDI: 00884450358016 Ref:28MC2813045/D- Lot # H2770016- UDI: 00884450358023 Ref:28MC28130SN/D- Lot # H2770029 and H2785162 - UDI: 00884450358030 Ref:28MC28130SN/F- Lot # H2750378 UDI: 00884450358290 Ref:28MC28130ST/D- Lot # H2752481 and H2766013 - UDI: 00884450358047 Ref:28MC28150SN/D- Lot # H2756905 and H2765969 - UDI: Ref:28MC28150SN/F- Lot # H2750387 UDI: 00884450358320 Ref:29MC2911045/D- Lot # H2758290 00884450358085 Ref:29MC29130SN/F- Lot # H2750390 00884450358382 Ref:29MC29130ST/D- Lot # H2750599 00884450358139 Ref:29MC29150ST/CNB- Lot # H2756603 00884450038383 Ref:29MC29150ST/D- Lot # H2749336,H2765976 and H2770087 - UDI: 00884450358160
Other Recalls from Merit Medical Systems, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1579-2026 | Class I | BioFlo DuraMax Catheter, REF: H965103028011/A, ... | Feb 13, 2026 |
| Z-1577-2026 | Class I | 16F Dual Valved Splittable Sheath Introducer (b... | Feb 13, 2026 |
| Z-1575-2026 | Class I | CentrosFLO Hemodialysis Catheters, REF: CENFP15... | Feb 13, 2026 |
| Z-1576-2026 | Class I | ProGuide Chronic Dialysis Catheters, REF: DC014... | Feb 13, 2026 |
| Z-1578-2026 | Class I | DuraMax Chronic Hemodialysis Catheter, REF: H78... | Feb 13, 2026 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
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.