Food, drugs, devices › LeMaitre Vascular, Inc.
Device recall: LeMaitre Vascular Tumescent Catheter Inversion (TCI) System. The TCI System is intended to provide a system to the remov
FDA enforcement event 70698 is a device recall by LeMaitre Vascular, Inc. of Burlington, MA, initiated 24 Feb 2015 and classified Class III, with 1 product record.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 4% of the 1,153 device enforcement events initiated in 2015 carry the same class.
Status: Terminated, terminated 21 May 2015. Initiation: voluntary: firm initiated. LeMaitre Vascular, Inc. has 20 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
LeMaitre Vascular, Inc., Burlington, MA.
Reason for recall
"Mislabeled with an incorrect expiration date"
Distribution
"CA, CO, KS, MN, UT, WA, WI"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1294-2015 | 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 | 54 units | Class III | Terminated | 25 Mar 2015 |
Context
Other enforcement events for LeMaitre Vascular, Inc.
All 20 events for LeMaitre Vascular, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Mislabeled with an incorrect expiration date"
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "CA, CO, KS, MN, UT, WA, WI"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 21 May 2015. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.