| Date Initiated by Firm | August 28, 2026 |
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| Date Posted | October 07, 2026 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0117-2027 |
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| Recall Event ID |
99836 |
| 510(K)Number | K022145 |
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| Product Classification |
Catheter, embolectomy - Product Code DXE
|
| Product | TufTex Over-the-Wire Embolectomy Catheter;
Catalog Number: E1651-88; |
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| Code Information |
Catalog Number: E1651-88;
UDI-DI: 00840663100866;
Lot Number: XOT00002181; |
| FEI Number |
1220948
|
Recalling Firm/
Manufacturer |
LeMaitre Vascular, Inc.
32 3rd Ave
Burlington
MA
01803-4414
|
| For Additional Information Contact | Laurie Churchill
781-362-5449 |
|---|
Manufacturer Reason
for Recall | Devices failed in process testing related to the amount of pull force it can sustain prior to the balloon components failing. |
|---|
FDA Determined
Cause 2 | Under Investigation by firm |
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| 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. |
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| Quantity in Commerce | 54 |
|---|
| Distribution | US Nationwide distribution in the states of CA, FL, GA, KY, LA, NJ, OH, PA, SC.
|
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| Total Product Life Cycle | TPLC Device Report |
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|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = DXE
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