DLP Left Heart Vent Catheter May Not Retain Shape During Use
Medtronic is recalling 25,261 DLP Left Heart Vent Catheters (Model 12115) because they may not retain their shape. This Class I recall affects catheters distributed worldwide and in the US.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class I, which mandates a minimum severity score of 4 per the rubric rule. Although no illnesses or injuries are reported in the source text, the agency's own Class I designation indicates serious risk to patient health during cardiac surgical procedures.
Plain-English summary
Medtronic Perfusion Systems is recalling the DLP Left Heart Vent Catheter, Model 12115, a cardiac surgical device used to vent blood from the left heart during cardiopulmonary bypass procedures. The recalled catheters have a malleable body and vented connector.
The catheters may not retain their shape, which could compromise their ability to function properly during cardiac surgical procedures.
Approximately 25,261 units have been distributed worldwide, including throughout the United States. The affected devices are identified by specific serial numbers and UDI-DI codes (20643169880935, 00643169880931, 00681490463423).
Healthcare facilities and cardiac surgeons should discontinue use of affected units immediately and contact Medtronic Perfusion Systems for guidance on replacement or return of the devices.
The recalled product
- Product
- DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12115 LV VENT 15FR, Model Number 12115
- Manufacturer
- Medtronic Perfusion Systems
- Hazard
- device-malfunction
- shape-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- UDI-DI: 20643169880935
- 00643169880931
- 00681490463423
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighGE CARESCAPE Telemetry Server may lose patient ECG and oxygen saturation monitoring
FDA (Devices) · 2026-06-03
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- HighPhilips Azurion and Allura Imaging Systems Recalled for Hard Drive Degradation
FDA (Devices) · 2026-06-03
- HighPhilips Allura Imaging Systems Hard Drive Degradation Affects Functionality
FDA (Devices) · 2026-06-03