LeMaitre Embolectomy Catheter e1601-48Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00840663100606), received between Feb 12, 2016 and Sep 5, 2025 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (7 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 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 5, 2025Material Rupture; Material Separation; Material Rupture; Material Separation

  IT WAS REPORTED THAT THE PATIENT WAS UNDERGOING LOWER EXTREMITY VASCULAR SURGERY (THROMBECTOMY) DUE TO CONCERN FOR ARTERIAL OCCLUSION. DURING A PORTION OF THE PROCEDURE, AFTER EVACUATING THROMBUS, THE CATHETER PASSED PROXIMALLY IN THE FEMORAL ARTERY WHEN IT BECAME LODGED AND COULD NOT BE REMOVED AFTER MULTIPLE ATTEMPTS. FEMORAL ARTERIOTOMY WAS PERFORMED TO LOCATE THE CATHETER WHICH WAS IN THE PROFUNDA FEMORIS ARTERY. PROFUNDA WAS DISSECTED, BUT THE TIP OF CATHETER COULD NOT BE RELEASED WITH ATTEMPTS TO PASS EMBOLECTOMY CATHETERS PROXIMALLY TO IT OR WITH INSTRUMENTATION USED TO DISLODGE IT. THE CATHETER WAS PULLED FROM THE ARTERY, AND THE BALLOON SECTION WAS NOTED TO HAVE BEEN SEPARATED FROM THE CATHETER SHAFT. IT COULD NOT BE PALPATED IN THE PROFUNDA. LENGTH OF THE CATHETER WAS COMPARED BY MARKINGS WITH ANOTHER 4FR EMBOLECTOMY CATHETER ON THE FIELD TO DETERMINE THAT APPROXIMATELY 1.5-2CM BALLOON TIP SEGMENT REMAINED IN THE PATIENT. THE PART OF THE VESSEL WHERE THE CATHETER BECAME STUCK CONTAINED AN AREA OF CALCIFIED PLAQUE. THE CATHETER TIP IS BELIEVED TO BE RETAINED IN A SMALL ARTERIAL BRANCH OFF THE PROFUNDA VESSEL AND IS NOT BELIEVED TO PRESENT RISK OF HARM TO THE PATIENT GOING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22977551 ↗
• MalfunctionJun 12, 2024Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT THE TUFTEX EMBOLECTOMY CATHETER BALLOON WOULD NOT DEFLATE. A NEW CATHETER WAS USED TO COMPLETE THE OPERATION. THE DEVICE WAS NOT IN DIRECT CONTACT WITH THE PATIENT. NO INJURY WAS REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19519779 ↗
• MalfunctionApr 19, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOONS OF FIVE TUFTEX EMBOLECTOMY CATHETERS RUPTURED DURING AN EMBOLECTOMY DE-CLOT PROCEDURE. THE PRODUCTS WERE RETAINED AT THE HOSPITAL. NO INJURY OCCURRED. PLEASE NOTE THAT REPORTS 1220948-2023-00058, 1220948-2023-00063, 1220948-2023-00064, 1220948-2023-00065 AND 1220948-2023-00066 WERE SUBMITTED FOR EACH DEVICE INVOLVED IN THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16771144 ↗
• MalfunctionApr 19, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOONS OF FIVE TUFTEX EMBOLECTOMY CATHETERS RUPTURED DURING AN EMBOLECTOMY DE-CLOT PROCEDURE. THE PRODUCTS WERE RETAINED AT THE HOSPITAL. NO INJURY OCCURRED. PLEASE NOTE THAT REPORTS 1220948-2023-00058, 1220948-2023-00063, 1220948-2023-00064, 1220948-2023-00065 AND 1220948-2023-00066 WERE SUBMITTED FOR EACH DEVICE INVOLVED IN THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16771140 ↗
• MalfunctionApr 19, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOONS OF FIVE TUFTEX EMBOLECTOMY CATHETERS RUPTURED DURING AN EMBOLECTOMY DE-CLOT PROCEDURE. THE PRODUCTS WERE RETAINED AT THE HOSPITAL. NO INJURY OCCURRED. PLEASE NOTE THAT REPORTS 1220948-2023-00058, 1220948-2023-00063, 1220948-2023-00065 AND 1220948-2023-00066 WERE SUBMITTED FOR EACH DEVICE INVOLVED IN THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16771099 ↗
• MalfunctionApr 19, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOONS OF FIVE TUFTEX EMBOLECTOMY CATHETERS RUPTURED DURING AN EMBOLECTOMY DE-CLOT PROCEDURE. THE PRODUCTS WERE RETAINED AT THE HOSPITAL. NO INJURY OCCURRED. PLEASE NOTE THAT REPORTS 1220948-2023-00058, 1220948-2023-00064, 1220948-2023-00065 AND 1220948-2023-00066 WERE SUBMITTED FOR EACH DEVICE INVOLVED IN THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16771087 ↗
• MalfunctionApr 19, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOONS OF FIVE TUFTEX EMBOLECTOMY CATHETERS RUPTURED DURING AN EMBOLECTOMY DE-CLOT PROCEDURE. THE PRODUCTS WERE RETAINED AT THE HOSPITAL. NO INJURY OCCURRED. PLEASE NOTE THAT REPORTS 1220948-2023-00063, 1220948-2023-00064, 1220948-2023-00065 AND 1220948-2023-00066 WERE SUBMITTED FOR EACH DEVICE INVOLVED IN THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16771039 ↗
• MalfunctionNov 14, 2019Deflation Problem; Deflation Problem

  DURING FEMORAL ENDARTERECTOMY, USING A 4F LEMAITRE EMBOLECTOMY CATHETER FOR DE-CLOTTING, SURGEON REPORTED THAT HE COULD NOT DEFLATE THE BALLOON OF THE CATHETER DURING USE. HE HAD TO CUT THE CATHETER LUMEN TO DEFLATE THE BALLOON AND REMOVE IT FROM PATIENT'S VESSEL. THERE WAS NO INJURY TO THE PATIENT AS THE RESULT OF THIS INCIDENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9324147 ↗
• MalfunctionNov 14, 2019Inflation Problem; Inflation Problem

  DURING PRE-USE CHECK, WHEN SURGEON ATTEMPTED TO INFLATE THE INTERNAL CAROTID BALLOON WITH SALINE, IT FAILED TO INFLATE. HE OBSERVED A LIQUID LEAKAGE FROM THE SAFETY BALLOON THAT RESULTED IN THIS DEVICE MALFUNCTION. DEVICE WAS NOT USED FOR THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9324140 ↗
• MalfunctionSep 21, 2016Detachment Of Device Component; Material Rupture; Detachment Of Device Component; Material Rupture

  FROM THE HOSPITALS DESCRIPTION OF THE INCIDENT, IT APPEARS AS THOUGH A 4 FRENCH LEMAITRE EMBOLECTOMY CATHETER WAS USED TO EITHER OCCLUDE THE AORTA DURING THE PLACEMENT OF AN ENDOVASCULAR STENT OR TO REMOVE ARTERIAL EMBOLI AND THROMBI. AT SOME POINT DURING THE PROCEDURE THE SURGEON NOTICED THAT THE BALLOON WAS NOT ATTACHED TO THE CATHETER. THE BALLOON WAS RETRIEVED WITH NO FURTHER ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5967708 ↗
• InjuryFeb 12, 2016Break; Deflation Problem

  THE BALLOON TIP OF THE LEMAITRE SINGLE LUMEN EMBOLECTOMY CATHETER BROKE OFF DURING THE PROCEDURE IN THE PATIENT'S COMMON ILLIAC ARTERY. THE CATHETER WAS PASSED SEVERAL TIMES TO REMOVE SOME THROMBUS AND ALLOW BLOOD FLOW. AN ANGIOGRAM INDICATED SOME STENOSIS AND AN ANGIOPLASTY WITH STENT PLACEMENT WAS PERFORMED, BUT BLOOD FLOW WAS STILL DIMINISHED. THE CATHETER WAS AGAIN PASSED WITHOUT DIFFICULTY REMOVING A CHUNK OF THROMBUS AND IMPROVING BLOOD FLOW WHICH REMAINED NON-PULSATILE. THE CATHETER WAS PASSED ANOTHER TIME, BUT THE PHYSICIAN WAS UNABLE TO GET THE CATHETER BACK PAST THE STENT. THE CATHETER LUMEN SNAPPED AND THE REMAINDER OF THE CATHETER CAME OUT. THE AREA WAS VISUALIZED UNDER FLUOROSCOPY AND THE BALLOON WAS NOTED TO STILL BE INFLATED. ATTEMPTS TO DEFLATE THE BALLOON WERE UNSUCCESSFUL AND FINALLY ANOTHER EMOBOLECTOMY CATHETER WAS USED IN AN ATTEMPT TO REMOVE THE BALLOON. THE BALLOON REMAINED STUCK AND IT WAS DEEMED SAFER TO LEAVE THE BROKEN TIP IN THE VESSEL. THE VESSEL WAS TIED OFF AND FEM-FEM BYPASS WAS PERFORMED.

  Patient problems: Device Embedded In Tissue or Plaque; Stenosis

  MAUDE report 5434958 ↗

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-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-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-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