Reported Sep 29, 2021 · Ongoing
DLP Left Heart Vent Catheters, 16 FR. Sterile, Rx Only
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?
- DLP Left Heart Vent Catheters, 16 FR. Sterile, Rx Only
- Lot codes and dates
- Model/Reference Number 12116
- Lot Number (GTIN Number)
178 of 178 codes
2018080039 (20643169086719)2018091020 (20643169086719)2018100911 (20643169086719)2018111023 (20643169086719)2018111419 (20643169086719)2019120925 (20643169086719)2018080039 (00673978462943)2018091020 (00673978462943)2018100911 (00673978462943)2018111023 (00673978462943)2018111419 (00673978462943)2018120581 (20643169086719)2018120581 (00673978462943)2018120582 (20643169086719)2018120582 (00673978462943)2018121084 (20643169086719)2018121084 (00673978462943)2019010456 (20643169086719)2019010456 (00673978462943)2019010764 (20643169086719)2019010764 (00673978462943)2019020136 (20643169086719)2019020136 (00673978462943)2019020368 (20643169086719)2019020368 (00673978462943)2019020758 (20643169086719)2019020758 (00673978462943)2019030720 (20643169086719)2019030720 (00673978462943)2019031167 (20643169086719)2019031167 (00673978462943)2019040262 (20643169086719)2019040262 (00673978462943)2019040472 (20643169086719)2019040472 (00673978462943)2019040473 (20643169086719)2019040473 (00673978462943)2019041189 (20643169086719)2019041189 (00673978462943)2019050576 (20643169086719)2019050576 (00673978462943)2019060984 (20643169086719)2019060984 (00673978462943)2019071114 (20643169086719)2019071114 (00673978462943)2019090071 (20643169086719)2019090071 (00673978462943)2019091024 (20643169086719)2019091024 (00673978462943)2019100417 (20643169086719)2019100417 (00673978462943)2019101444 (20643169086719)2019101444 (00673978462943)2019111049 (20643169086719)2019111049 (00673978462943)2019120925 (00673978462943)2020010368 (20643169086719)2020010368 (00673978462943)2020010445 (20643169086719)2020010445 (00673978462943)
- Expiration date range09/30/2020 - 05/19/2024
- Amount recalled
- 51,494 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Potential for a wire protrusion through the left heart vent catheter tip
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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