TufTex Over-the-Wire Embolectomy Catheter Recall
TufTex¿ Over-the-Wire Embolectomy Catheter; Catalog Number: E1651-88;
What is the FDA recall status?
The FDA record lists this recall as ongoing. FDA enforcement data is not a live recall-lifecycle tracker. Follow the official instructions and check the agency notice or firm for current guidance.
Why was TufTex Over-the-Wire Embolectomy Catheter recalled?
Devices failed in process testing related to the amount of pull force it can sustain prior to the balloon components failing.
What should I do if I have this product?
Follow the firm and FDA instructions for the affected product. Contact the recalling firm for current guidance.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare your product with the product description and available lot, UPC or model codes below from the official FDA record to check whether it is covered by this recall. If an identifier is missing or unclear, check the complete official notice or contact the firm; an incomplete match here does not establish that your product is unaffected.
Which lot codes, UPCs or models are affected?
Catalog Number: E1651-88; UDI-DI: 00840663100866; Lot Number: XOT00002181;
- Agency record number
- Z-0117-2027
- Product
- TufTex¿ Over-the-Wire Embolectomy Catheter; Catalog Number: E1651-88;
- Recalling firm
- LeMaitre Vascular, Inc.
- Quantity
- 54
- Distribution
- US Nationwide distribution in the states of CA, FL, GA, KY, LA, NJ, OH, PA, SC.
- Recall started
- August 28, 2026
- Report date
- October 14, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)