The Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda Bioactive Surface is a...
FDA Device Recall #Z-0531-2015 — Class II — October 31, 2014
Recall Summary
| Recall Number | Z-0531-2015 |
| Classification | Class II — Moderate risk |
| Date Initiated | October 31, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Medtronic Perfusion Systems |
| Location | Brooklyn Park, MN |
| Product Type | Devices |
| Quantity | 66, UPDATE: 168 additional devices. |
Product Description
The Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda Bioactive Surface is a single-use, microporous, hollow-fiber, gas-exchange device with plasma resistant fiber and integrated heat exchanger and arterial filter. The oxygenator is bonded on its primary blood contacting surfaces with a non-leaching biocompatible surface to reduce platelet activation and adhesion and preserve platelet function. The device is non-toxic, nonpyrogenic, and supplied sterile in individual packaging.
Reason for Recall
Medtronic initiated an Urgent Medical Device Recall for 66 distributed Affinity FusionTM Oxygenation Systems with Carmeda Bioactive Surface due to damaged heat exchangers. Product affected by this issue is limited to model CB841 sold stand alone or incorporated in Total Systems TS1614R1 and TS1595R7. UPDATED: Recall was updated to incorporate three additional lots affected.
Distribution Pattern
US Distribution to states of: CA and FL. UPDATED: OUS: Czech Republic and Switzerland.
Lot / Code Information
Lot number 12981001 with the following Serial Numbers: 8110138055 8110141155 8110141281 8110141459 8110138056 8110141162 8110141304 8110141469 8110138061 8110141167 8110141305 8110141471 8110138096 8110141168 8110141315 8110141497 8110139306 8110141182 8110141320 8110141518 8110139330 8110141184 8110141331 8110141527 8110139856 8110141188 8110141335 8110141533 8110140819 8110141193 8110141342 8110141587 8110140824 8110141215 8110141368 8110141604 8110140985 8110141219 8110141380 8110141605 8110141045 8110141222 8110141391 8110141613 8110141082 8110141230 8110141403 8110141616 8110141083 8110141238 8110141415 8110141621 8110141114 8110141240 8110141416 8110141705 8110141119 8110141244 8110141418 8110141731 8110141127 8110141247 8110141421 8110141739 8110141128 8110141253 8110141423 8110141750 8110141138 8110141258 8110141431 8110141782 8110141142 8110141260 8110141445 8110141788 8110141153 8110141279 8110141452 8110141798 UPDATED: Lot # 13011880, 13 (serial # 8110141520), 13023057 (Serial # 8110141435 and 8110141539).
Other Recalls from Medtronic Perfusion Systems
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1473-2026 | Class II | Octopus Nuvo Tissue Stabilizer, disposable tiss... | Jan 13, 2026 |
| Z-0539-2026 | Class II | Medtronic HR-ACT (High Range Activated Clotting... | Oct 20, 2025 |
| Z-0509-2026 | Class II | MC3 VitalFlow Console, REF 58100; Blood pump of... | Oct 3, 2025 |
| Z-0487-2026 | Class II | Affinity NT Oxygenator, Oxygenator with Balance... | Sep 12, 2025 |
| Z-2481-2025 | Class I | DLP Left Heart Vent Catheter Malleable body and... | Aug 6, 2025 |
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.