Left heart vent catheters 13FR recalled because they may not retain shape
DLP Left Heart Vent Catheters, model 12113, are recalled because the catheters may not retain their shape. The FDA classified the action as Class I. 34,549 units are affected.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The rubric assigns 5 to any FDA Class I recall, and the FDA classified this vent catheter action as Class I.
Plain-English summary
The DLP Left Heart Vent Catheter with malleable body and vented connector, Suction 12113 LV Vent 13FR, model number 12113, is being recalled. Affected units carry UDI-DI numbers 20643169881338, 00673978176475 and 00643169881334, with serial numbers listed in the recall notice. The recall covers 34,549 units distributed nationwide in the United States and internationally.
The recall was issued because the catheters may not retain their shape. The FDA classified the action as Class I, its most serious category.
Hospitals and cardiac surgery units holding affected serial numbers should quarantine them and follow the manufacturer's instructions for return.
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
- Category
- Medical Device — Cardiac Surgery
- Affected units
- 34,549
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.
Part of a larger recall action
This product is one of 3 recalled by Medtronic Perfusion Systems under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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