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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
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