Reported May 21, 2025 · Ongoing
TufTex Over-the-Wire Embolectomy Catheter. All Catalog numbers: 1651-34, 1651-38, 1651-44, 1651-48, 1651-58, 1651-64,…
LeMaitre Vascular, Inc.
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: LeMaitre Vascular, Inc. · 32 3rd Ave · Burlington, MA · 01803-4414
Is this the product you have?
- TufTex Over-the-Wire Embolectomy Catheter
- All Catalog numbers
1651-341651-381651-441651-481651-581651-641651-681651-781651-841651-88E1651-34E1651-38E1651-44E1651-48E1651-64E1651-68E1651-78E1651-84E1651-881651-44J1651-48J1651-84J1651-88J
- Lot codes and dates
- UDI-DI
008406631006510084066310066800840663100675008406631006820084066310069900840663100705008406631007120084066310072900840663107551008406631007360084066310074300840663100750008406631007670084066310077400840663100781008406631007980084066310080400840663100811008406631008280084066310083500840663107568008406631008420084066310085900840663100866
- Catalog numbers
1651-341651-381651-441651-481651-681651-781651-841651-88E1651-34E1651-38E1651-44E1651-48E1651-64E1651-68E1651-78E1651-84E1651-88. Lots
- not expired with the following prefixOTW, QOT, XOT, COT
- UDI-DI
- Amount recalled
- 237,611 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
- GA
Why it was recalled
During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
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.
Free recall alerts
Get alerted about new packaged foods recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.