LeMaitre Embolectomy Catheter 1651-38Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00840663100668), received between Aug 23, 2019 and Dec 16, 2025 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (7 reports).

1 FDA recall record name this device's identifier, 1 still open.

10 other recalls cover devices cleared under the same FDA submission (K022145); 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.

Recalls naming this device

1. Apr 11, 2025Class IIOpen, Classified

   During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).

   Z-1750-2025 · Root cause: Packaging process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 16, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING A THROMBECTOMY PROCEDURE, THE BALLOON RUPTURED. A REPLACEMENT DEVICE WAS USED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23817695 ↗
• MalfunctionMay 21, 2024Material Rupture; Material Rupture

  THE BALLOON RUPTURED WHILE INFLATING IN THE BLOOD VESSEL. ANOTHER CATHETER OF THE SAME SIZE (SAME LOT NUMBER) WAS PREPARED TO CONTINUE THE OPERATION AND WAS SUCCESSFULLY COMPLETED. THE FRAGMENTS OF THE BALLOON DID NOT REMAIN IN THE BLOOD VESSEL. NO INJURY WAS REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19362881 ↗
• MalfunctionDec 29, 2023Failure to Deflate; Failure to Deflate

  THE CATHETER WAS PREPARED AND INSERTED INTO THE VESSEL. THE BALLOON WAS THEN INFLATED WITH THE DILUTED CONTRAST MEDIUM. DURING THE THROMBECTOMY, AN ATTEMPT WAS MADE TO DEFLATE THE BALLOON, BUT IT WAS DIFFICULT TO DEFLATE AS IT TOOK LONGER THAN USUAL. THEREFORE, THIS CATHETER WAS NO LONGER USED AND A NEW CATHETER OF THE SAME SIZE WAS PREPARED. THE OPERATION WAS SUCCESSFULLY COMPLETED WITH REPLACEMENT CATHETER. NO INJURY WAS REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18419234 ↗
• MalfunctionSep 27, 2023Deflation Problem; Inflation Problem; Deflation Problem; Inflation Problem

  THE BALLOON DID NOT WORK UNLESS IT WAS INFLATED AND DEFLATED MUCH STRONGER THAN USUAL DURING INFLATION AND DEFLATION CHECK. THEREFORE, THE CATHETER WAS REPLACED WITH A NEW ONE. THE OPERATION WAS SUCCESSFULLY COMPLETED AFTERWARDS. NO INJURY WAS REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17825058 ↗
• MalfunctionJun 8, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THE BALLOON RUPTURED DURING PREPARATION OF THE CATHETER. NO PATIENT INURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17088839 ↗
• MalfunctionMay 31, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT WHILE USING THE TUFTEX OVER-THE-WIRE EMBOLECTOMY CATHETER TO PERFORM THE THROMBECTOMY FOR A LOWER EXTREMITY THROMBOSIS TWO CATHETERS FAILED. FOR THE FIRST CATHETER, LEAKAGE OCCURRED AT THE CONNECTION BETWEEN THE INJECTION HUB AND CATHETER LUMEN DURING PRE-USE CHECK. THE ISSUE WAS NOTED PRIOR TO USE AND THERE WAS NO PATIENT RISK. THE SECOND CATHETER HAD NO PROBLEMS DURING THE PRE-USE CHECK. THE CATHETER WAS INSERTED INTO THE BLOOD VESSEL BUT WAS UNABLE TO INFLATE. UPON CHECKING THE BALLOON IT WAS OBSERVED RUPTURED. THE OPERATION WAS SUCCESSFULLY COMPLETED USING A THIRD CATHETER. NO INJURY OCCURRED. NOTE: THIS REPORT IS RELATED TO THE SECOND CATHETER USED IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17030971 ↗
• MalfunctionApr 6, 2023Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE USING A TUFTEX OVER-THE-WIRE EMBOLECTOMY CATHETER AFTER INFLATING THE BALLOON INSIDE THE BLOOD BESSEL, THE BALLOON LIKELY CAUGHT ON A CALCIFIED LESION DURING THE EMBOLECTOMY SO THE PHYSICIAN COULD NOT PULL OUT THE CATHETER. AS A RESULT, THE CATHETER SHAFT BROKE OFF IN THE MIDDLE. THE CATHETER WAS ABLE TO BE REMOVED BY PULLING THE BROKEN PORTION. THERE WERE NO REMNANTS LEFT INSIDE THE VESSEL. ANOTHER CATHETER WAS USED TO COMPLETE THE OPERATION. NO INJURY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16691300 ↗
• MalfunctionOct 26, 2022Failure to Deflate; Failure to Deflate

  DURING PRE-USE CHECK, AN INFLATION TEST ON THE TUFTEX OVER-THE-WIRE EMBOLECTOMY CATHETER FOUND THE BALLOON WAS UNABLE TO DEFLATE. THE OPERATION WAS SUCCESSFULLY COMPLETED USING ANOTHER CATHETER. THE PRODUCT WAS NOT USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15676296 ↗
• MalfunctionOct 14, 2021Failure to Deflate; Failure to Deflate

  DURING THE THROMBECTOMY PROCEDURE, WHEN THE SURGEON ATTEMPTED TO DEFLATE THE BALLOON OF THE LEMAITRE OVER-THE-WIRE EMBOLECTOMY PROCEDURE, HE WAS UNABLE TO DEFLATE THE BALLOON. HE OBSERVED AN ELONGATION OF THE CATHETER EXTRUSION NEAR THE Y-CONNECTOR. THE SURGEON THEN REPLACED THE CATHETER TO COMPLETE THE PROCEDURE. THERE WAS NO HARM TO THE PATIENT BECAUSE OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12636656 ↗
• MalfunctionJun 2, 2021Unsealed Device Packaging; Unsealed Device Packaging

  UPON RECEIVING A COMPLAINT RELATED TO OVER-THE-WIRE EMBOLECTOMY CATHETER'S TYVEK LID NOT BEING PROPERLY SEALED (MANUFACTURER'S INCIDENT REPORT# 1220948-2021-00053), THE DISTRIBUTOR REACHED OUT TO ANOTHER HOSPITAL TO WHOM THEY HAD SOLD THE OVER-THE-WIRE EMBOLECTOMY CATHETERS FROM THE SAME COMPLAINT LOT#. THE CUSTOMER CONFIRMED THAT 1 OUT OF 5 UNITS HAS A SIMILAR ISSUE AS WELL. THIS IS REPORT 2 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11925073 ↗
• MalfunctionJun 2, 2021Unsealed Device Packaging; Unsealed Device Packaging

  UPON RECEIVING, DURING A VISUAL INSPECTION OF THE PACKAGING TUBE, THE RECEIVER OBSERVED THAT THE TYVEK LID WAS FOUND UNSEALED AND SEPARATED FROM THE BOAT TRAY. THIS IS REPORT 1 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11925072 ↗
• MalfunctionFeb 3, 2021Deflation Problem; Deflation Problem

  RUPTURE OF THE EMBOLECTOMY CATHETER DURING SURGERY. THE INFLATED BALLOON THAT HAD REMAINED IN THE PATIENT'S ARTERY COULD BE REMOVED ANYWAY. AS THE INTEGRITY OF THE DMS HAS BEEN REMOVED, CLOSER MONITORING OF THE PATIENT WAS SUFFICIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11276285 ↗
• MalfunctionJul 3, 2020Material Rupture; Material Rupture

  DURING PRE-USE CHECK, THE BALLOON OF AN OVER-THE-WIRE EMBOLECTOMY CATHETER BURST WHEN SURGEON ATTEMPTED TO INFLATE THE BALLOON WITH SALINE. DEVICE DID NOT COME IN CONTACT WITH THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 10228452 ↗
• MalfunctionApr 3, 2020Deflation Problem; Deflation Problem

  DURING A THROMBECTOMY PROCEDURE, THE BALLOON OF AN OVER-THE-WIRE EMBOLECTOMY CATHETER FAILED TO DEFLATE. SURGEON HAD TO PULL THE CATHETER TO REMOVE THE UNDEFLATED BALLOON FROM THE PATIENT'S VESSEL. THERE WAS NO INJURY TO THE PATIENT AS THE RESULT OF THIS INCIDENT. THIS IS REPORT 1 OF 2.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9924923 ↗
• MalfunctionApr 3, 2020Deflation Problem; Deflation Problem

  DURING A THROMBECTOMY PROCEDURE, THE BALLOON OF AN OVER-THE-WIRE EMBOLECTOMY CATHETER FAILED TO DEFLATE. SURGEON HAD TO PULL THE CATHETER TO REMOVE THE UNDEFLATED BALLOON FROM THE PATIENT'S VESSEL. THERE WAS NO INJURY TO THE PATIENT AS THE RESULT OF THIS INCIDENT. THIS IS REPORT 2 OF 2.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9924919 ↗
• MalfunctionMar 30, 2020Deflation Problem; Deflation Problem

  DURING A THROMBECTOMY PROCEDURE, THE BALLOON OF AN OVER-THE-WIRE EMBOLECTOMY CATHETER FAILED TO DEFLATE. SURGEON HAD TO PULL THE CATHETER TO REMOVE THE UNDEFLATED BALLOON FROM THE 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 9900479 ↗
• MalfunctionMar 24, 2020Deflation Problem; Deflation Problem

  DURING A THROMBECTOMY PROCEDURE, THE BALLOON OF AN OVER-THE-WIRE EMBOLECTOMY CATHETER FAILED TO DEFLATE. SURGEON HAD TO PULL THE CATHETER TO REMOVE THE UNDEFLATED BALLOON FROM THE PATIENT'S VESSEL. THERE WAS NO INJURY TO THE PATIENT AS THE RESULT OF THIS INCIDENT. THIS IS REPORT 1 OF 2.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9875534 ↗
• MalfunctionMar 24, 2020Deflation Problem; Deflation Problem

  DURING A THROMBECTOMY PROCEDURE, THE BALLOON OF AN OVER-THE-WIRE EMBOLECTOMY CATHETER FAILED TO DEFLATE. SURGEON HAD TO PULL THE CATHETER TO REMOVE THE UNDEFLATED BALLOON FROM THE PATIENT'S VESSEL. THERE WAS NO INJURY TO THE PATIENT AS THE RESULT OF THIS INCIDENT. THIS IS REPORT 2 OF 2.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9875533 ↗
• MalfunctionAug 23, 2019Unintended Movement; Unintended Movement

  DURING THROMBECTOMY OF A HEMODIALYSIS PATIENT WITH STENOSIS, LEMAITRE OVER-THE-WIRE EMBOLECTOMY CATHETER WAS USED TO REMOVE THE THROMBUS. THROMBECTOMY WAS PERFORMED MULTIPLE TIMES ABOVE THE STENOSIS REGION WITH AN ATTEMPT TO REMOVE THE THROMBUS. DURING THIRD PASS, THE INFLATED BALLOON COULD NOT PASS BEYOND THE STENOTIC REGION. ALTHOUGH SURGEON ATTEMPTED TO DEFLATE THE BALLOON MULTIPLE TIMES, HE WAS UNABLE TO DO SO. SURGEON RELUCTANTLY PULLED THE CATHETER TO REMOVE IT FROM THE PATIENT'S VESSEL. AS A RESULT OF THIS, THE TIP OF THE CATHETER SEPARATED FROM THE CATHETER SHAFT. SURGEON WAS ABLE TO RETRIEVE THE CATHETER TIP FROM THE PATIENT'S VESSEL. THE STENOTIC REGION WAS SURGICALLY REPAIRED USING ARTIFICIAL BLOOD VESSEL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8926633 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K022145. One submission often covers many models, so check the product and lot details in each record.

• Z-0117-2027 · Aug 28, 2026 · Open, Classified
  TufTex Over-the-Wire Embolectomy Catheter; Catalog Number: E1651-88;
• Z-1567-2020 · Mar 23, 2020 · Open, Classified
  LeMaitre 5F Plus Over the Wire Embolectomy Catheter, Model Nos. 1651-84, e1651-84, 1651-88, e1651-88. The LeMaitre Over the Wire Embolectomy Catheter is indicated for use in the r
• Z-0383-2016 · Oct 21, 2015 · Terminated
  LeMaitre Over-the-Wire Embolectomy Catheter 5F Plus, 40 cm, Model e1651-84. Indicated for the removal of arterial emboli and thrombi.
• Z-0379-2016 · Oct 21, 2015 · Terminated
  LeMaitre Over-the-Wire Embolectomy Catheter 3F, 80cm, Model 1651-38. Indicated for the removal of arterial emboli and thrombi.
• Z-0382-2016 · Oct 21, 2015 · Terminated
  LeMaitre Over-the-Wire Embolectomy Catheter 7F, 80cm, Model 1654-78 and e1654-78. Indicated for the removal of arterial emboli and thrombi.
• Z-0380-2016 · Oct 21, 2015 · Terminated
  LeMaitre Over-the-Wire Embolectomy Catheter 4F, 80cm, Model 1651-48 and e1654-48. Indicated for the removal of arterial emboli and thrombi.
• Z-0381-2016 · Oct 21, 2015 · Terminated
  LeMaitre Over-the-Wire Embolectomy Catheter 5F Plus, 80cm, Model 1651-88 and e1654-88. Indicated for the removal of arterial emboli and thrombi.
• Z-0378-2016 · Oct 21, 2015 · Terminated
  LeMaitre Over-the-Wire Embolectomy Catheter 3F, 40cm, Model 1651-34 and e1651-34. Indicated for the removal of arterial emboli and thrombi.
• Z-0385-2016 · Oct 21, 2015 · Terminated
  LeMaitre Over-the-Wire Embolectomy Catheter 6F, 80 cm, Model e-1651-68. Indicated for the removal of arterial emboli and thrombi.
• Z-0384-2016 · Oct 21, 2015 · Terminated
  LeMaitre Over-the-Wire Embolectomy Catheter 6F, 40 cm, Model e-1651-64. Indicated for the removal of arterial emboli and thrombi.