Reported May 22, 2024 · Ongoing
Medtronic Left Heart Vent Catheters
Medtronic Perfusion Systems
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Perfusion Systems · 7611 Northland Dr N · Brooklyn Park, MN · 55428-1088
Is this the product you have?
Medtronic Left Heart Vent Catheters
8 of 8 products
| Model / number | Product as published |
|---|---|
12012 | DLP¿ Intracardiac Sump 20 Fr |
12008 | DLP¿ Left Heart Vent Catheter 10 Fr. |
12001 | DLP¿ Left Heart Vent Catheter 13 Fr. |
12113 | DLP¿ Left Heart Vent Catheter 13 Fr. |
12016 | DLP¿ Left Heart Vent Catheter 16 Fr. |
12002 | DLP¿ Left Heart Vent Catheter 20 Fr. |
12220 | DLP¿ Left Heart Vent Catheter 20 Fr. |
12010 | DLP¿ Pericardial Sump 38.1 cm (15 in) |
- Lot codes and dates
13 of 13 products
Products covered by this recall Model / number Product as published 20613994619246Model Number 12012, , Lot Numbers: 2023050080, 202306C144 00643169880665Model Number 12008, , Lot Numbers: 2023040819 00673978176307Model Number 12008, , Lot Numbers: 2023040819, 2023040820 20643169880669Model Number 12008, , Lot Numbers: 2023040819, 2023040820, 202307C103 00643169878686Model Number 12001, , Lot Numbers: 2023040810 20643169878680Model Number 12001, , Lot Numbers: 2023040810, 2023040811, 202306C141 20643169881338Model Number 12113, , Lot Numbers: 2023090675 20613994540434Model Number 12016, , Lot Numbers: 2023050083, 202305C093 20613994540465Model Number 12002, , Lot Numbers: 2023041178, 202305C079 00613994540355Model Number 12220, , Lot Numbers: 2023041202, 2023050095 20613994540359Model Number 12220, , Lot Numbers: 2023041202, 2023050095, 202305C096, 202306C159 00673978176321Model Number 12010, , Lot Numbers: 2023041180, 2023041182, 2023041183, 2023041188, 2023041189, 2023050075 20613994619215Model Number 12010, , Lot Numbers: 2023041180, 2023041181, 2023041182, 2023041183, 2023041184, 2023041188, 2023041189, 2023050075, 202305C086, 202305C087 - Amount recalled
- 13954 units
This recall covers 13 products
The agency filed one notice per product. You are reading one of them; the other 12 are below.
Why it was recalled
Potential for unsealed sterile packing.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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