Z-1294-2015Class III

LeMaitre Vascular Tumescent Catheter Inversion (TCI) System. The TCI System is intended to provide a system...

Name: Z-1294-2015 LeMaitre Vascular Tumescent Catheter Inversion (TCI) System. The TCI System is intended to provide a system...
Creator: LeMaitre Vascular, Inc.
Published: 2015-02-24
License: https://open.fda.gov/license/

LeMaitre Vascular Inc. / initiated 2015-02-24 / Terminated / root cause: manufacturing process

FDA source

LeMaitre Vascular, Inc. began a recall of LeMaitre Vascular Tumescent Catheter Inversion (TCI) System. The TCI System is intended to provide a system to the removal of an incompetent greater saphenous... on 2015-02-24. FDA classified it as Class III and gives the reason as "Mislabeled with an incorrect expiration date". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1294-2015
Classification: Class III
Status: Terminated
Initiated: 2015-02-24
Posted: 2015-03-18
Terminated: 2015-05-21
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
Product code: DWQ Stripper, Vein, External
Reason for recall: Mislabeled with an incorrect expiration date
Root cause tag: manufacturing process
FDA 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 in commerce: 54 units
Distribution: CA, CO, KS, MN, UT, WA, WI
Product codes and lots: Lot Number: 61049252 Exp. Date: 2016-06

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1294-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1294-2015	Class III	Terminated	Voluntary: Firm initiated	2015-03-25	2015-03-18

Product code DWQ

K041453Class IISmith & Nephew Tumescent Catheter Inversion System, Model 7210023Smith & Nephew, Inc. / cleared 2004-07-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)