FDA Medical Device Recalls (openFDA)
Medtronic Perfusion Systems: Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.
- Recall number
- Z-0003-2022
- Recalling firm
- Medtronic Perfusion Systems
- Product
- Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.
- Status
- Open, Classified
- Initiated
- 2021-09-13
- Posted
- not on file
- Terminated
- not on file
- Reason
- There was a label mix-up between two model numbers resulting in the incorrect guidewire being contained in the kits for both model numbers.
- Root cause
- Under Investigation by firm
- Action
- The recalling firm issued letters dated September 2021 beginning 9/13/2021 via 2-day UPS delivery to consignees. For outside of the United States, the recall letter will be delivered via regionally-approved methods to consignees who received the product. The letter explains the issue and requests the consignee review their inventory for the affected product. The product is to be immediately quarantined and returned after first contacting Customer Service. A Customer Confirmation Form was enclosed to be returned via email. The letter was to be shared with others within their organization as appropriate and to any other locations who have received the product through a transfer. Consignees are asked to review the Medtronic Urgent Medical Device Recall notification and follow the Recommended Actions, including quarantining and returning all unused affected Bio-Medicus Insertion Kits in their inventory.
- Quantity
- 168 kits
- Distribution
- Worldwide distribution - US Nationwide distribution in the state of Massachusetts and the countries of Belgium, France, Germany Japan, Korea, Saudi Arabia, Spain, and Turkey.
- Lot, serial or model codes
- Model 96553 - Serial number 220719040, GTIN 20763000116006; Model 96551 - Serial number 220641720, GTIN 20763000115986.
- 510(k) numbers
- ["K190557"]
- PMA numbers
- not on file
- Product code
- DWF
- 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