Extra corporeal circuit with bio-active surface.
This recall has been terminated (originally issued August 8, 2018).
- Company
- Medtronic Perfusion Systems
- Recall Initiated
- August 8, 2018
- Terminated
- October 6, 2020
- Recall Number
- Z-2495-2020
- Quantity
- 10 units
- Firm Location
- Brooklyn Park, MN
- Official Source
- View on FDA website ↗
Reason for Recall
Affected products failed a sterilization test.
Distribution
Domestic Distribution only to CA and MI.
Lot / Code Info
Lot# 215729283
Root Cause
Nonconforming Material/Component
Action Taken
On August 8th Medtronic vervally communicated to the consignees to informed them about the situation and affected product. On August 20th they send a letter to the consignees stating that "as a result of the immediate verbal communication, your Medtronic representative has already retrieved the affected product from your facility. This notification is for your awareness and Medtronic requests that you complete and return the attached Customer Confirmation Certificate to RS.CFQFCA@Medtronic.com."
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