LeMaitre Embolectomy Catheter 1801-58Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00840663100941), received between Jun 3, 2019 and Oct 3, 2024 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (6 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.

• MalfunctionOct 3, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT LIGATURE LOOSENED AND UNRAVELED FROM THE CATHETER IN A SPIRAL MANNER. THE PIECES ARE STILL ATTACHED TO THE CATHETER AND DID NOT HAVE TO BE REMOVED FROM THE VESSEL. THIS HAS OCCURRED ON 2 CATHETERS FROM LOT NSE2924. THE DEVICES WERE NOT PRE-CHECKED PRIOR TO USE. NO INJURY WAS REPORTED TO THE PATIENT. NOTE: THIS IS REPORT 2 OF 2 RELATED TO THE SECOND CATHETER USED IN THE EVENT. REPORTS 1220948-2024-00201 WAS SUBMITTED FOR THE FIRST DEVICE INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20358906 ↗
• MalfunctionOct 3, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT LIGATURE LOOSENED AND UNRAVELED FROM THE CATHETER IN A SPIRAL MANNER. THE PIECES ARE STILL ATTACHED TO THE CATHETER AND DID NOT HAVE TO BE REMOVED FROM THE VESSEL. THIS HAS OCCURRED ON 2 CATHETERS FROM LOT: NSE2924. THE DEVICES WERE NOT PRE-CHECKED PRIOR TO USE. NO INJURY WAS REPORTED TO THE PATIENT. NOTE: THIS IS REPORT 1 OF 2 RELATED TO THE FIRST CATHETER USED IN THE EVENT. REPORTS 1220948-2024-00202 WAS SUBMITTED FOR THE SECOND DEVICE INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20358880 ↗
• MalfunctionSep 24, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT FOUR SYNTEL SILICONE EMBOLECTOMY CATHETER - REGULAR TIP BALLOON RUPTURED DURING USE. NO INJURY WAS REPORTED TO THE PATIENTS. MORE INFORMATION IN REGARD TO THE REPORTED INCIDENTS WERE REQUESTED. NOTE: THIS IS REPORT 1 OF 4 RELATED TO THE FIRST CATHETER USED IN THE EVENT. REPORTS 1220948-2024-00188, 1220948-2024-00189, AND 1220948-2024-00190 WERE SUBMITTED FOR THE SECOND, THIRD, AND FORTH DEVICES INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20297838 ↗
• MalfunctionSep 24, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT FOUR SYNTEL SILICONE EMBOLECTOMY CATHETER - REGULAR TIP BALLOON RUPTURED DURING USE. NO INJURY WAS REPORTED TO THE PATIENTS. MORE INFORMATION IN REGARDS TO THE REPORTED INCIDENTS WERE REQUESTED. NOTE: THIS IS REPORT 3 OF 4 RELATED TO THE THIRD CATHETER USED IN THE EVENT. REPORTS 1220948-2024-00187, 1220948-2024-00188, AND 1220948-2024-00190 WERE SUBMITTED FOR THE FIRST, SECOND, AND FOURTH DEVICES INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20295260 ↗
• MalfunctionSep 24, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT FOUR SYNTEL SILICONE EMBOLECTOMY CATHETER - REGULAR TIP BALLOON RUPTURED DURING USE. NO INJURY WAS REPORTED TO THE PATIENTS. MORE INFORMATION IN REGARDS TO THE REPORTED INCIDENTS WERE REQUESTED. NOTE: THIS IS REPORT 2 OF 4 RELATED TO THE SECOND CATHETER USED IN THE EVENT. REPORTS 1220948-2024-00187, 1220948-2024-00189, AND 1220948-2024-00190 WERE SUBMITTED FOR THE FIRST, THIRD, AND FOURTH DEVICES INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20295068 ↗
• InjuryFeb 9, 2024Failure to Deflate; Failure to Deflate

  THE PATIENT WAS HAVING A PROCEDURE FOR A LEFT FEMORAL ENDARTERECTOMY. DURING THE PROCEDURE, THE PROBE WAS REMOVED BUT WITH THE BALLOON STILL INFLATED. THE SURGEON SETS UP THE PROBE AND ASKS TO INFLATE THE BALLOON. IN VIEW OF THE BLOOD RETURN (NON-ACTION OF THE BALLOON), THE SURGEON ASKS TO DEFLATE IT IN ORDER TO REMOVE THE BALLOON. DESPITE SEVERAL TESTS, THE PROBE DID NOT DEFLATE AND IT WAS IMPOSSIBLE TO REMOVE IT. BALLOON WAS DEFLATED WITH A SCALPEL BLADE AND WHILE PERFORMING THIS ACTION, THE FEMORAL ARTERY WAS STRIPPED. AS A RESULT OF THE INJURY THAT OCCURRED, AN ABDOMINAL INCISION WAS REQUIRED TO PERFORM A FEMORAL BYPASS AND RESULTED IN A LONGER INTERVENTION FOR THE PROCEDURE.

  Patient problems: Perforation of Vessels

  MAUDE report 18677178 ↗
• MalfunctionJan 3, 2024Material Rupture; Material Rupture

  IT WAS REPORTED WHEN THE CATHETER WAS PREPARED AND THE AIR INSIDE THE BALLOON WAS REMOVED WITH NORMAL SALINE, THE BALLOON EASILY RUPTURED. THE ISSUE OCCURRED WITH 2 CATHETERS. ANOTHER CATHETER OF THE SAME SIZE WAS PREPARED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING THE REPLACEMENT. NO INJURY WAS REPORTED TO THE PATIENT. NOTE: THIS IS REPORT 2 OF 2 RELATED TO THE SECOND CATHETER USED IN THE EVENT. REPORT 1220948-2023-00214 WAS SUBMITTED FOR THE FIRST DEVICE INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18436607 ↗
• MalfunctionJan 3, 2024Material Rupture; Material Rupture

  IT WAS REPORTED WHEN THE CATHETER WAS PREPARED AND THE AIR INSIDE THE BALLOON WAS REMOVED WITH NORMAL SALINE, THE BALLOON EASILY RUPTURED. THE ISSUE OCCURRED WITH 2 CATHETERS. ANOTHER CATHETER OF THE SAME SIZE WAS PREPARED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING THE REPLACEMENT. NO INJURY WAS REPORTED TO THE PATIENT. NOTE: THIS IS REPORT 1 OF 2 RELATED TO THE FIRST CATHETER USED IN THE EVENT. REPORT 1220948-2023-00215 WAS SUBMITTED FOR THE SECOND DEVICE INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18436565 ↗
• MalfunctionJun 3, 2019Material Rupture; Material Rupture

  THE SURGEON REPORTED THAT THE BALLOONS OF THE LEMAITRE NOVASIL SINGLE LUMEN EMBOLECTOMY CATHETERS BURST DURING EMBOLECTOMY PROCEDURE WHEN THE BALLOONS WERE EXPOSED TO HIGHLY CALCIFIED VESSEL. THIS IS REPORT 1 OF 3 OF THAT SERIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8664929 ↗

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-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-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-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-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-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-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