- 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: 20763000135670, Lot Numbers: 0232601501 0232601510 0232601549 0232601550 0232602178 0232602290 0232602302 0232910952 0232910953 0232910954 0232910955 0233244075 0233244301 0233244531 0233286362 0233286374 0233286390 0233409034 0233416071 0233528731
- Units affected
- 13,510 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-2808-2026
- 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