The Recall Desk
SevereFDA (Devices)·Z-2481-2025·Announced 2025-09-10

DLP Left Heart Vent Catheter Recalled for Loss of Shape Retention

Medtronic is recalling DLP Left Heart Vent Catheters (Model 12110) because they may not retain their shape during use. This defect could affect device function in cardiac surgical procedures.

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: This is an FDA Class I medical device recall. Per the rubric, Class I recalls require a minimum severity of Severe. No illnesses or injuries have been reported to date, but shape-retention loss in a critical cardiac surgical device poses potential for serious harm during procedures.

Plain-English summary

Medtronic Perfusion Systems is recalling 41,200 units of the DLP Left Heart Vent Catheter, Model 12110, used during cardiac surgery to drain fluid from the left side of the heart.

The catheters may not retain their shape as designed. Affected units were distributed nationwide and worldwide, with serial numbers documented from December 2023 through June 2024.

Hospitals and surgical facilities should immediately discontinue use of affected catheters and contact Medtronic for replacement or disposal instructions. The FDA classified this as a Class I recall.

The recalled product

Product
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT 10FR, Model Number 12110
Manufacturer
Medtronic Perfusion Systems
Category
Medical Device — Cardiac Surgery Equipment
Hazard
  • structural-defect
  • device-malfunction

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 (5)

  • UDI-DI: 20643169880676
  • 00643169880672
  • 00673978176468
  • 00763000946432
  • 20763000946436

Distribution

Distributed nationwide across the United States.

Related recalls

Same category