- Recalling firm
- Medtronic Perfusion Systems
- Reason for recall
- During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.
- Affected products (lot / model / serial)
- UDI-DI: 00763000543679; Serial Numbers: 0231266463 0231468923 0231478249 0231478253 0231478260 0231651627 0231651634 0231651636 0231651637 0231651638 0231651639 0231651641 0231651642
- Units affected
- 590 units
- Distribution pattern
- Worldwide - US Nationwide distribution.
- Firm location
- Brooklyn Park, MN, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2577-2026
- Recall initiated
- May 12, 2026
- FDA classification date
- June 24, 2026
- FDA report date
- July 1, 2026
- FDA event ID
- 98966
- Last updated on HTM Vibe
- July 23, 2026