FDA Medical Device Recalls (openFDA)
LeMaitre Vascular, Inc.: LeMaitre Stent Guide: 1102-00 (100 strips); 1102-50 (50 strips); 1102-20 (20 strips). Intended to be placed on the skin to assist during imaging procedures.
- Recall number
- Z-1054-2013
- Recalling firm
- LeMaitre Vascular, Inc.
- Product
- LeMaitre Stent Guide: 1102-00 (100 strips); 1102-50 (50 strips); 1102-20 (20 strips). Intended to be placed on the skin to assist during imaging procedures.
- Status
- Terminated
- Initiated
- 2013-03-18
- Posted
- 2013-04-04
- Terminated
- 2014-12-03
- Reason
- Devices were not sealed correctly during the manufacturing process, and the sterility of these products have been compromised.
- Root cause
- Packaging process control
- Action
- LeMaitre sent an "URGENT:VASCUTAPE RADIOPAQUE TAPE DEVICE FIELD SAFETY NOTICE" dated March 20, 2013 to affected customers. The recall letter contains a form that requests customers to return to LeMaitre Vascular, Inc. as a record of notification and reconciliation. The letter provides instructions on how the customer can inspect the defective tape seals and/or return the affected products for replacement/credit.
- Quantity
- 6970
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Canada, EU, and Asia.
- Lot, serial or model codes
- LSG1130, exp. 2017-04; LSG1132, exp. 2017-11
- 510(k) numbers
- ["K932184"]
- PMA numbers
- not on file
- Product code
- KFX
- Firm FEI
- 1220948
- Firm city
- Burlington
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28