LeMaitre Embolectomy Catheter 1601-58Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00840663100514), received between Jun 5, 2017 and Feb 12, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (8 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2026Material Rupture

  IT WAS REPORTED THAT THE TUFTEX EMBOLECTOMY CATHETER EXPERIENCED BALLOON RUPTURE DURING AN ACUTE LIMB ISCHEMIA PROCEDURE. THE DEVICE WAS CHECKED PRIOR TO USE AND FOUND TO BE ACCEPTABLE. NO PATIENT INJURY WAS REPORTED. NOTE: THIS IS REPORT 3 OF 3 RELATED TO THE THIRD CATHETER USED IN THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24321267 ↗
• MalfunctionFeb 12, 2026Material Rupture

  IT WAS REPORTED THAT THE TUFTEX EMBOLECTOMY CATHETER EXPERIENCED BALLOON RUPTURE DURING AN ACUTE LIMB ISCHEMIA PROCEDURE. THE DEVICE WAS CHECKED PRIOR TO USE AND FOUND TO BE ACCEPTABLE. NO PATIENT INJURY WAS REPORTED. NOTE: THIS IS REPORT 2 OF 3 RELATED TO THE SECOND CATHETER USED IN THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24321243 ↗
• MalfunctionFeb 12, 2026Material Rupture

  IT WAS REPORTED THAT THE TUFTEX EMBOLECTOMY CATHETER EXPERIENCED BALLOON RUPTURE DURING AN ACUTE LIMB ISCHEMIA PROCEDURE. THE DEVICE WAS CHECKED PRIOR TO USE AND FOUND TO BE ACCEPTABLE. NO PATIENT INJURY WAS REPORTED. NOTE: THIS IS REPORT 1 OF 3 RELATED TO THE FIRST CATHETER USED IN THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24321235 ↗
• MalfunctionSep 11, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING A CHOLECYSTECTOMY PROCEDURE, WHEN THE CATHETER WAS INTRODUCED THROUGH THE BILE DUCT FOR STONE EXTRACTION, IT FAILED TO INFLATE. UPON REMOVAL, THE BALLOON WAS FOUND TO BE RUPTURED. IT IS IMPORTANT TO NOTE THAT PRIOR TO USE, THE CATHETER HAD BEEN INFLATED WITH SALINE SOLUTION WITHOUT ANY ISSUES. NO INJURY WAS REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23024605 ↗
• MalfunctionAug 4, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE TUFTEX EMBOLECTOMY CATHETER BALLOON RUPTURED DURING INSERTION INTO THE PATIENT. THE RUPTURED BALLOON WAS COMPLETELY REMOVED, AND NO FRAGMENTS REMAINED IN THE PATIENT. NO INJURY WAS REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22710738 ↗
• MalfunctionNov 26, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING A THROMBECTOMY PROCEDURE THIS TUFTEX 5F SUCCESSFULLY REMOVED FRESH THROMBUS ON THE FIRST PASSAGE, BUT ON THE SECOND PASSAGE THE BALLOON RUPTURED AT 18CM BEFORE THE DISTAL ANASTOMOSIS. NO INJURY WAS REPORTED TO THE PATIENT. NOTE: THIS IS REPORT 1 OF 3 RELATED TO THE FIRST CATHETER USED IN THE EVENT. REPORTS 1220948-2024-00236 AND 1220948-2024-00237 WERE SUBMITTED FOR THE SECOND AND THIRD DEVICES INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20776964 ↗
• MalfunctionNov 25, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING A THROMBECTOMY PROCEDURE THIS TUFTEX 5F WAS THE SECOND DEVICE USED. WHEN INSERTED IT CROSSED THE LESION SUCCESSFULLY AND REMOVED THE THROMBUS BUT RUPTURED ON THE SECOND PASSAGE. NO INJURY WAS REPORTED TO THE PATIENT. NOTE: THIS IS REPORT 2 OF 3 RELATED TO THE SECOND CATHETER USED IN THE EVENT. REPORTS 1220948-2024-00235 AND 1220948-2024-00237 WERE SUBMITTED FOR THE FIRST AND THIRD DEVICES INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20774541 ↗
• MalfunctionMay 21, 2022Material Rupture; Material Rupture

  DURING A THROMBECTOMY PROCEDURE, THE BALLOON OF THE TUFTEX EMBOLECTOMY CATHETER RUPTURED WHEN THE SURGEON ATTEMPTED TO REMOVE THE THROMBUS FROM THE PATIENT'S VESSEL. THE BALLOON RUPTURED IN HIS 4TH PASS. THE SURGEON FAILED HIS FIRST THREE ATTEMPTS TO REMOVE THE THROMBUS FROM THE PATIENT'S VESSEL. THERE WAS NO HARM TO THE PATIENT BECAUSE OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14466011 ↗
• MalfunctionJun 5, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING REDO FEM-FEM CROSSOVER, THE TIP OF AN EMBOLECTOMY CATHETER BROKE OFF INSIDE A PATIENT'S ARTERY. THE PIECE WAS APPROXIMATELY 1.5CM LONG WITH THE BALLOON ATTACHED.

  Patient problems: Foreign Body In Patient

  MAUDE report 6612790 ↗

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-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-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-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-0557-05 · Feb 7, 2005 · Terminated
  LeMaitre Embolectomy Catheter 2F Single Lumen, Balloon Volume 0.05 ml, Length 60 cm. Latex Model: 1601-26
• 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-0558-05 · Feb 7, 2005 · Terminated
  LeMaitre Embolectomy Catheter 3F Single Lumen, Balloon volume 0.2ml, Length 80 cm, Latex Model: 1601-38