FDA Medical Device Recalls (openFDA)
Medtronic Perfusion Systems: Extra corporeal circuit with bio-active surface.
- Recall number
- Z-2495-2020
- Recalling firm
- Medtronic Perfusion Systems
- Product
- Extra corporeal circuit with bio-active surface.
- Status
- Terminated
- Initiated
- 2018-08-08
- Posted
- not on file
- Terminated
- 2020-10-06
- Reason
- Affected products failed a sterilization test.
- Root cause
- Nonconforming Material/Component
- Action
- 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."
- Quantity
- 10 units
- Distribution
- Domestic Distribution only to CA and MI.
- Lot, serial or model codes
- Lot# 215729283
- 510(k) numbers
- ["K891687"]
- PMA numbers
- not on file
- Product code
- DTZ
- Firm FEI
- 1000116158
- Firm city
- Brooklyn Park
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28