LeMaitre Embolectomy Catheter 1601-28Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00840663100453), received between Jul 3, 2024 and Nov 26, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (3 reports).

9 other recalls cover devices cleared under the same FDA submission (K992368); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 26, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE TUFTEX SLC BALLOON RUPTURED IN A PATIENT'S VESSEL DURING A PROCEDURE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23654269 ↗
• MalfunctionNov 4, 2025Material Rupture; Material Separation; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE BALLOON DETACHED AND REMAINED INSIDE THE PATIENT. RETRIEVAL OF THE BALLOON TOOK AN EXTENDED PERIOD OF TIME, WHICH PROLONGED THE PROCEDURE AND ANESTHESIA DURATION. NO FURTHER ISSUES OR PATIENT INJURY WERE REPORTED. NOTE: THIS IS REPORT 2 OF 2 RELATED TO THE SECOND CATHETER USED IN THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23472440 ↗
• MalfunctionNov 4, 2025Material Rupture; Material Separation; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE BALLOON DETACHED AND REMAINED INSIDE THE PATIENT. RETRIEVAL OF THE BALLOON TOOK AN EXTENDED PERIOD OF TIME, WHICH PROLONGED THE PROCEDURE AND ANESTHESIA DURATION. NO FURTHER ISSUES OR PATIENT INJURY WERE REPORTED. NOTE: THIS IS REPORT 1 OF 2 RELATED TO THE FIRST CATHETER USED IN THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23472406 ↗
• MalfunctionJul 3, 2024Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT THE TUFTEX EMBOLECTOMY CATHETER BALLOON WAS NOT DEFLATING. THE PHYSICIAN HAD TO DEFLATE THE BALLOON BY POPPING IT WITH A SCALPEL. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO INJURY WAS REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19665816 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K992368. One submission often covers many models, so check the product and lot details in each record.

• Z-0228-2023 · Sep 30, 2022 · Open, Classified
  TufTex Embolectomy Catheter, Model No. This catheter has a latex balloon and a single lumen extrusion. It is inserted using a guidewire or introducer. The devices affected by thi
• Z-0387-2016 · Oct 21, 2015 · Terminated
  LeMaitre Single Lumen Embolectomy Catheter 4F, 80 cm, Model 1601-48 and e1601-48. Indicated for the removal of arterial emboli and thrombi.
• Z-0388-2016 · Oct 21, 2015 · Terminated
  LeMaitre Single Lumen Embolectomy Catheter 5F, 80 cm, Model 1601-58 and e1601-58. Indicated for the removal of arterial emboli and thrombi.
• Z-0389-2016 · Oct 21, 2015 · Terminated
  LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 6F, 80 cm, Model 1601-68. Indicated for the removal of arterial emboli and thrombi.
• Z-0386-2016 · Oct 21, 2015 · Terminated
  LeMaitre Single Lumen Embolectomy Catheter 3F, 80 cm, Model 1601-38 and e1601-38. Indicated for the removal of arterial emboli and thrombi.
• Z-0390-2016 · Oct 21, 2015 · Terminated
  LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 2F, 60 cm, Model e1801-26. Indicated for the removal of arterial emboli and thrombi.
• Z-0558-05 · Feb 7, 2005 · Terminated
  LeMaitre Embolectomy Catheter 3F Single Lumen, Balloon volume 0.2ml, Length 80 cm, Latex Model: 1601-38
• Z-0560-05 · Feb 7, 2005 · Terminated
  LeMaitre Embolectomy Catheter 5F Single Lumen, Balloon Volume 1.5 ml, Length 80 cm, Latex Model: 1601-58
• Z-0557-05 · Feb 7, 2005 · Terminated
  LeMaitre Embolectomy Catheter 2F Single Lumen, Balloon Volume 0.05 ml, Length 60 cm. Latex Model: 1601-26