Product is a Pruitt Aortic Occlusion Catheter contained in… recallZ-0219-06 · LeMaitre Vascular, Inc. · initiated May 17, 2005
Terminated All recalls posted in November 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
LeMaitre Vascular is recalling certain lots of its Pruitt Aortic Occlusion Catheters due to a packaging defect which could compromise product sterility.
FDA root cause category: Other
What the company is doing
The distributors in Europe and Japan have been notified to contact their customers to return the products. All customers have been notified by letter.
Recall details
- Recall number
- Z-0219-06
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- May 17, 2005
- Posted by the FDA
- Nov 30, 2005
- Recalling firm
- LeMaitre Vascular, Inc.
- Quantity
- 1,919
- Product code
- DQT
- FDA submissions
- K872090
- Distribution
- There are two lots in distribution (175 pieces) that may contain the small hole in the tray. These two lots were distributed in Japan and Europe. There are 16 lots in distribution (1,744 pieces) that utilize the trays with the thin spots that can potentially crack. These 16 lots were distributed in the United States, Canada, Japan and the European Union.
Product description
Product is a Pruitt Aortic Occlusion Catheter contained in a molded tray. The product is labeled in part: ''***LeMaitre VASCULAR***Distributed By:LeMaitre Vascular, Inc.***Manufactured By: LeMaitre Vascular, Inc. 3101 37th Avenue North St. Petersburg, FL 33713***Pruitt Aortic Occlusion Catheter***REF 2101-12***STERILE***''.
Code information (models, lots, serial numbers)
Lot No: 1010505-07, 1010505-08, 1030404-09, 104104-05, 1041404-06, 1042204-12, 1042704-01, 1042704-03, 1052204-01, 1061404-04, 1061404-05, 1070204-03, 1080204-08, 1082304-06, l100604-01, l100704-01, l120104-02, l121604-04.
Other devices under the same FDA submission
1 device cleared under K872090 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Pruitt Aortic Occlusion Catheter 2100-12Lemaitre Vascular, Inc. · Occluder, Catheter Tip6 reports
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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