Reported Oct 9, 2019 · Completed
SHERPA NX ACTIVE GUIDING CATHETER, 6F ALR1-2, .070", REF SA6ALR12. for cardiovascular use
Medtronic Vascular
High riskUsing this product could cause serious injury, illness or death — stop using it now.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 Vascular · 35 Cherry Hill Dr # 37a · Danvers, MA · 01923-2565
Is this the product you have?
SHERPA NX ACTIVE GUIDING CATHETER6F ALR1-2.070"REF SA6ALR12. for cardiovascular use
- Lot codes and dates
- GTIN00613994823946 All Lot/Serial Numbers
- Amount recalled
- 163 units
This recall covers 191 products
The agency filed one notice per product. You are reading one of them; the other 190 are below.
178 more are in the archive.
Why it was recalled
Stop using this product now
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Using this product could cause serious injury, illness or death — stop using it now.
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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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