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LeMaitre Embolectomy Catheter recallZ-0117-2027 · LeMaitre Vascular, Inc. · initiated Aug 28, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from LeMaitre Vascular, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Devices failed in process testing related to the amount of pull force it can sustain prior to the balloon components failing.

FDA root cause category: Under Investigation by firm

What the company is doing

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.

Recall details

Recall number
Z-0117-2027
Status
Open, Classified
Initiated by the company
Aug 28, 2026
Posted by the FDA
Oct 7, 2026
Recalling firm
LeMaitre Vascular, Inc.
Quantity
54
Product code
DXE
FDA submissions
K022145
Distribution
US Nationwide distribution in the states of CA, FL, GA, KY, LA, NJ, OH, PA, SC.

Product description

TufTex Over-the-Wire Embolectomy Catheter; Catalog Number: E1651-88;

Code information (models, lots, serial numbers)

Catalog Number: E1651-88; UDI-DI: 00840663100866; Lot Number: XOT00002181;

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

21 devices cleared under K022145 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page