Lemaitre Vascular, Inc.: Catheter, Embolectomy
- Recalling firm
- LeMaitre Vascular, Inc.
- Product
- TufTex Over-the-Wire Embolectomy Catheter; Catalog Number: E1651-88;
- Reason
- Devices failed in process testing related to the amount of pull force it can sustain prior to the balloon components failing.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-08-28
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution in the states of CA, FL, GA, KY, LA, NJ, OH, PA, SC.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/021f408b-59cf-449d-9b50-8f42ecbbfd43