LeMaitre Embolectomy Catheter 3F Single Lumen, Balloon… recallZ-0558-05 · Lemaitre Vascular, Inc. · initiated Feb 7, 2005
Terminated All recalls posted in February 2005
Is my device affected?
- 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.
- 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.
- 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
Product sterility maybe compromised due to defective packaging
FDA root cause category: Other
What the company is doing
LaMaitre notified consignees by lettter advising users to check inventory and return defective product.
Recall details
- Recall number
- Z-0558-05
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Feb 7, 2005
- Posted by the FDA
- Feb 24, 2005
- Recalling firm
- Lemaitre Vascular, Inc.
- Quantity
- 692 units
- Product code
- DXE
- FDA submissions
- K992368
- Distribution
- AL, CA, FL, IN, MD, MI,NY, TN, FOREIGN: Germany
Product description
LeMaitre Embolectomy Catheter 3F Single Lumen, Balloon volume 0.2ml, Length 80 cm, Latex Model: 1601-38
Code information (models, lots, serial numbers)
Lot Numbers: SLC1201, SLC1213
Other devices under the same FDA submission
25 devices cleared under K992368 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- LeMaitre Embolectomy Catheter 1601-48Lemaitre Vascular, Inc. · Catheter, Embolectomy24 reports
- LeMaitre Embolectomy Catheter 1601-44Lemaitre Vascular, Inc. · Catheter, Embolectomy22 reports
- LeMaitre Embolectomy Catheter 1601-38Lemaitre Vascular, Inc. · Catheter, Embolectomy16 reports
- LeMaitre Embolectomy Catheter 1801-48Lemaitre Vascular, Inc. · Catheter, Embolectomy12 reports
- LeMaitre Embolectomy Catheter e1601-48Lemaitre Vascular, Inc. · Catheter, Embolectomy11 reports
- LeMaitre Embolectomy Catheter 1601-58Lemaitre Vascular, Inc. · Catheter, Embolectomy9 reports
- LeMaitre Embolectomy Catheter 1801-58Lemaitre Vascular, Inc. · Catheter, Embolectomy9 reports
- LeMaitre Embolectomy Catheter e1801-44Lemaitre Vascular, Inc. · Catheter, Embolectomy6 reports
- LeMaitre Embolectomy Catheter e1801-48Lemaitre Vascular, Inc. · Catheter, Embolectomy5 reports
- LeMaitre Embolectomy Catheter 1601-28Lemaitre Vascular, Inc. · Catheter, Embolectomy4 reports
- LeMaitre Embolectomy Catheter 1801-38Lemaitre Vascular, Inc. · Catheter, Embolectomy4 reports
- LeMaitre Embolectomy Catheter e1601-26Lemaitre Vascular, Inc. · Catheter, Embolectomy3 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 31108).
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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