Medtronic Perfusion Systems Recalls Extra Corporeal Circuits Due to Sterilization Failure
Medtronic Perfusion Systems is recalling 10 extra corporeal circuits with bio-active surfaces because they failed a sterilization test. The units were distributed only to California and Michigan.
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 that failed a sterilization test, which poses a risk of harm (infection) even though no injuries or illnesses have been reported. This aligns with the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medtronic Perfusion Systems is recalling 10 units of extra corporeal circuits with bio-active surfaces. The recall was initiated because the affected products failed a sterilization test.
The recalled units, identified by Lot# 215729283, were distributed domestically only to California and Michigan. The source text does not specify the number of patients affected or report any illnesses or injuries associated with the use of these devices.
Consumers and healthcare facilities should stop using the affected units and contact Medtronic Perfusion Systems for further instructions on how to return or dispose of the products.
The recalled product
- Product
- Extra corporeal circuit with bio-active surface.
- Manufacturer
- Medtronic Perfusion Systems
- Affected units
- 10
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 (1)
- Lot# 215729283
Distribution
Related recalls
Same manufacturer · Medtronic Perfusion Systems
See all →- SevereMedtronic Perfusion Systems Recalls EOPA Elongated One-Piece Arterial Cannula Model 77522
FDA (Devices) · 2026-08-05
- 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 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 · sterilization failure
See all →- SevereSteris Recalls VERIFY Biological Steam Test Packs Due to Spore Population Concerns
FDA (Devices) · 2026-10-14
- HighSteris VERIFY Dual Species Biological Indicator Recall for Spore Population Issues
FDA (Devices) · 2026-10-14
- SevereSteris VERIFY Biological Indicator Recall Due to Spore Population Concerns
FDA (Devices) · 2026-10-14
- SevereSteris VERIFY Biological Steam Test Pack Recalled for Spore Population Defect
FDA (Devices) · 2026-10-14
- SevereSteris VERIFY Biological/Integrator Challenge Pack Recall for Spore Population Defect
FDA (Devices) · 2026-10-14
Similar recalls
- HighMedtronic Perfusion Tubing Packs Recalled Due to Suction Wand Issue
FDA (Devices) · 2013-09-04
- HighMedtronic Perfusion Tubing Packs Recalled for Insufficient or Incomplete Welds
FDA (Devices) · 2021-06-23
- SevereMedtronic Bio-Console 560 Blood Pumping Console Recalled for Electrical Failure
FDA (Devices) · 2021-04-07
- HighMedtronic Perfusion System Tubing Packs Recalled for Incomplete Welds
FDA (Devices) · 2021-06-23
- HighMedtronic Custom Perfusion Systems Recalled Due to Valve Flow Defect
FDA (Devices) · 2018-02-14
- HighMedtronic Perfusion System Tubing Packs Recalled for Weld Defects
FDA (Devices) · 2021-06-23