TufTex Over-the-Wire Embolectomy Catheter; Catalog Number: E1651-88;
FDA Recall Z-0117-2027 · Posted 2026-10-07
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Recalling FirmLeMaitre Vascular, Inc.
Recall StatusOpen, Classified
Product CodeDXE
Date Initiated2026-08-28
Product Quantity54
Reason for Recall
Devices failed in process testing related to the amount of pull force it can sustain prior to the balloon components failing.
Firm Action
On August 28, 2026 URGENT: MEDICAL DEVICE RECALL letters were sent to customers.
Actions to be taken:
1. Check your inventory against the list of lots in this letter. Immediately quarantine any recalled devices.
2. Complete the form at the end of this letter. Please note that you must return the form even if you have no devices in inventory.
3. LeMaitre customer service will provide an RMA number to coordinate the product return.
4. When a recalled device has been returned to LeMaitre Vascular, a replacement device will be provided.
5. If you have transferred devices to another facility, please forward a copy of this recall letter to them.
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide distribution in the states of CA, FL, GA, KY, LA, NJ, OH, PA, SC.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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