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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. 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.
See all 3 products in this recall →Related recalls
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