FDA Medical Device Recalls (openFDA)
LeMaitre Vascular, Inc.: LeMaitre Vascular Tumescent Catheter Inversion (TCI) System. The TCI System is intended to provide a system to the removal of an incompetent greater saphenous vein. Catalog Number: 7210023, lot #61049252
- Recall number
- Z-1294-2015
- Recalling firm
- LeMaitre Vascular, Inc.
- Product
- LeMaitre Vascular Tumescent Catheter Inversion (TCI) System. The TCI System is intended to provide a system to the removal of an incompetent greater saphenous vein. Catalog Number: 7210023, lot #61049252
- Status
- Terminated
- Initiated
- 2015-02-24
- Posted
- 2015-03-18
- Terminated
- 2015-05-21
- Reason
- Mislabeled with an incorrect expiration date
- Root cause
- Employee error
- Action
- LeMaitre Vascular issued a Field Safety Notice/Dear Doctor dated 2/24/15 to customers The letter provides information on the recalled product and instructions on how the customer can inspect for the defective devices and return the affected products for replacement/credit. The letter contains a form that is requested to be returned to LeMaitre Vascular, Inc. as a record of notification and reconciliation. Questions, contact 781-221-2266 ext. 183
- Quantity
- 54 units
- Distribution
- CA, CO, KS, MN, UT, WA, WI
- Lot, serial or model codes
- Lot Number: 61049252 Exp. Date: 2016-06
- 510(k) numbers
- ["K041453"]
- PMA numbers
- not on file
- Product code
- DWQ
- 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
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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