Medtronic Custom Perfusion Systems Recalled Due to Valve Flow Defect
Medtronic is recalling 2,914 custom perfusion systems because Terumo OPS valves may lack flow. The devices are used in cardiopulmonary bypass surgery.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device used in life-sustaining surgery with a functional defect (lack of flow), but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medtronic Perfusion Systems is recalling 2,914 units of Medtronic Custom Perfusion Systems. These devices are indicated for use in the extracorporeal circuit during cardiopulmonary bypass (CPB) surgical procedures. The recall is due to the presence of Terumo OPS valves that were previously recalled for a lack of flow through the valve.
The affected units were distributed in Delaware, Iowa, California, and Japan. The source text does not specify the number of patients affected or report any illnesses or injuries associated with this recall.
Healthcare providers should stop using the affected units and contact Medtronic Perfusion Systems for further instructions. Consumers should not use these devices if they have them in their possession.
The recalled product
- Product
- Medtronic Custom Perfusion Systems, indicated for use in the extracorporeal circuit during cardiopulmonary bypass (CPB) surgical procedures.
- Manufacturer
- Medtronic Perfusion Systems
- Affected units
- 2,914
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- a) REF 2815R1
- UPN/GTIN: 20885074191038
- Lot/Serial Numbers: 210937492
- 213151103
- 213671744 b) REF 2D25R6
- UPN/GTIN: 00613994268174
- Lot/Serial Numbers: 209533592
- 209759280
- 209948919
- 210174899
- 210377603
- 210478517
- 210591995
- 210767149
- 211011818
- 211210404
- 211243436
- 211542842
- 211761616 c) REF 9M68R
- UPN/GTIN: 20643169876648
Distribution
Related recalls
Same manufacturer · Medtronic Perfusion Systems
See all →- HighArterial Cannula Recall: EOPA 3D 22FR May Develop Pinhole Leaks During Bypass
FDA (Devices) · 2026-08-05
- SevereMedtronic Perfusion Systems Recalls EOPA Elongated One-Piece Arterial Cannula Model 77522
FDA (Devices) · 2026-08-05
- SevereMedtronic Perfusion Systems Recalls EOPA Elongated One-Piece Arterial Cannula Model 77722
FDA (Devices) · 2026-08-05
- HighArterial Cannula Recalled Due to Risk of Pinhole Leaks During Bypass
FDA (Devices) · 2026-08-05
- HighArterial Cannula Recalled Due to Pinhole Leaks During Cardiopulmonary Bypass
FDA (Devices) · 2026-08-05
Same hazard · device malfunction
See all →- HighPhilips Incisive CT Recalled for Potential Failure to Trigger Clinical Scan
FDA (Devices) · 2026-09-02
- HighBoston Scientific Recalls Suture Cinch Endoscopic Tissue Approximation Devices
FDA (Devices) · 2026-08-26
- HighBD Needle Kit for Powered Driver Recall Due to Removal Difficulty
FDA (Devices) · 2026-08-26
- SevereGEM Premier 5000 PAK Lysing Solution Concentration Recall
FDA (Devices) · 2026-08-12
- HighIntegrated Medcraft Recalls First Aid Kits with Defective Airway Tips
FDA (Devices) · 2026-08-12