CLASS I Device recall · Reported 24 Mar 2021 · FDA Enforcement Report
Cardiopulmonary bypass oxygenator) recalled
Medtronic Perfusion Systems is recalling Cardiopulmonary bypass oxygenator), distributed nationwide in the US. The recall was initiated on 4 Feb 2021 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1198-2021
- FDA event ID
- 87271
- Recalling firm
- Medtronic Perfusion Systems, Brooklyn Park, MN
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 4 Feb 2021
- FDA classified
- 17 Mar 2021
- Reported
- 24 Mar 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 4 Feb 2021 | Recall initiated by company | |
| 17 Mar 2021 | Classified by FDA | +41 days |
| 24 Mar 2021 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response.
Product as listed by the FDA
Medtronic Custom Pack CP 1/4-1/4 Pediatric Set 1/B (PERFUSION M484901D 1/B). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is collected, filtered, and defoamed before mixing with the venous blood, which is filtered. The primary blood-contacting surfaces of the CVR are coated with Balance Biosurface to reduce platelet activation and adhesion and preserve platelet function. (Generic Name: Cardiopulmonary bypass oxygenator).
Where it was distributed
Worldwide distribution: US nationwide, Afghanistan, Argentina, Chile, China, Colombia, Egypt, Germany, Iraq, Italy, Japan, Korea, Kyrgyzstan, Latvia, Nicaragua, Paraguay, Poland, Qatar, Romania, Tanzania, United Arab Emirates, United Kingdom, Uzbekistan, and Viet Nam
Questions about this recall
Is Cardiopulmonary bypass oxygenator) recalled?
Yes. Medtronic Perfusion Systems recalled Cardiopulmonary bypass oxygenator) on 4 Feb 2021. The recall is Class I and its status is Terminated. Recall number Z-1198-2021.
Why was it recalled?
Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response.
Which lots are affected?
Description: PERFUSION M484901D 1/B. Model Number: M484901D. GTIN: 00763000240288. Lot Number: 220906731.
Where was it sold?
Worldwide distribution: US nationwide, Afghanistan, Argentina, Chile, China, Colombia, Egypt, Germany, Iraq, Italy, Japan, Korea, Kyrgyzstan, Latvia, Nicaragua, Paraguay, Poland, Qatar, Romania, Tanzania, United Arab Emirates, United Kingdom, Uzbekistan, and Viet Nam
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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