FDA-Device2026-10-14Class IIPROCESSING DEFECT
LeMaitre Vascular TufTex Over-the-Wire Embolectomy Catheter recalled for balloon failure under pull force
What this means
LeMaitre Vascular's TufTex Over-the-Wire Embolectomy Catheter (Catalog Number E1651-88, Lot XOT00002181) failed internal testing. The balloon components can fail when exposed to pull force during use, which could compromise the device's ability to remove blood clots safely.
- If you have this device in your facility, stop using it immediately.
- Contact LeMaitre Vascular or your supplier for instructions on return or disposal.
- Review your records to identify affected lot number XOT00002181.
The agency's original wording
Hazard
Devices failed in process testing related to the amount of pull force it can sustain prior to the balloon components failing.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the states of CA, FL, GA, KY, LA, NJ, OH, PA, SC.
Affected count
54
Manufactured in
32 3rd Ave, N/A, Burlington, MA, United States
Products
TufTex¿ Over-the-Wire Embolectomy Catheter; Catalog Number: E1651-88;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0117-2027Want us to check the next one for you?
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