- Recalling firm
- Medtronic Perfusion Systems
- Reason for recall
- Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration or perforation, hypotension, ischemia, and organ dysfunction.
- Affected products (lot / model / serial)
- UDI-DI: 20199150023251, Lot Numbers: 0232709184 0232745036 0232798416 0232862784 0232862787; UDI-DI: 00199150023257, Lot Numbers: 0232862787
- Units affected
- 1,424 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-2811-2026
- Recall initiated
- June 24, 2026
- FDA classification date
- July 27, 2026
- FDA report date
- August 5, 2026
- FDA event ID
- 99320
- Last updated on HTM Vibe
- August 11, 2026