Medtronic DLP Left Heart Vent Catheter May Not Retain Shape
Medtronic is recalling 34,549 DLP Left Heart Vent Catheters (Model 12113) because the catheters may not retain their shape. The defect affects devices distributed worldwide and could compromise catheter function during cardiac surgery.
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: FDA Class I classification establishes a minimum severity of 4 per regulatory guidance. Although no illnesses or injuries have been reported, this catheter is a critical surgical device where shape retention is essential for safe function during cardiac procedures. The structural defect presents significant potential for harm in the surgical setting.
Plain-English summary
Medtronic Perfusion Systems is recalling the DLP Left Heart Vent Catheter, Model 12113 (SUCTION 12113 LV VENT 13FR), a specialized medical device used during cardiac surgery for left-heart venting.
The recalled catheters have a malleable body that may not retain their proper shape. This structural defect compromises the device's functional integrity during surgical procedures.
Approximately 34,549 units have been distributed worldwide and throughout the United States. The affected devices were manufactured between 2023 and early 2024, identified by specific serial numbers and UDI codes (20643169881338, 00673978176475, 00643169881334).
This is an FDA Class I recall, the agency's most serious classification for medical devices.
The recalled product
- Product
- DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12113 LV VENT 13FR, Model Number 12113
- Manufacturer
- Medtronic Perfusion Systems
- Hazard
- device-malfunction
- structural-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: 20643169881338
- 00673978176475
- 00643169881334
Distribution
Distributed nationwide across the United States.
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