LeMaitre Embolectomy Catheter 1651-84Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00840663100743), received between Mar 12, 2021 and Aug 26, 2026 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (21 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2026Material Rupture

  It was reported that the TufTex OTW balloon ruptured during a procedure. The device was pre-checked prior to use. No patient injury was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50453451 ↗
• MalfunctionMar 13, 2026Material Rupture

  IT WAS REPORTED THAT THE TUFTEX OTW BALLOON RUPTURED DURING PREOPERATIVE INSPECTION PRIOR TO PATIENT USE AND WAS THEREFORE NOT UTILIZED IN THE PROCEDURE. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24589537 ↗
• MalfunctionNov 10, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE TUFTEX OTW BALLOON RUPTURED DURING PRE-TESTING. THE DEVICE WAS NOT USED ON THE PATIENT. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS 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 23510931 ↗
• MalfunctionNov 10, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE TUFTEX OTW BALLOON RUPTURED DURING PRE-TESTING. THE DEVICE WAS NOT USED ON THE PATIENT. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS 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 23510908 ↗
• MalfunctionNov 10, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE TUFTEX OTW BALLOON RUPTURED DURING PREPARATION. THE DEVICE WAS NOT USED ON THE PATIENT. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23510178 ↗
• MalfunctionMar 4, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE TUFTEX OTW BALLOON RUPTURED DURING A PROCEDURE. NO INJURY WAS REPORTED TO THE PATIENT. 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 21512345 ↗
• MalfunctionMar 4, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE TUFTEX OTW BALLOON RUPTURED DURING A PROCEDURE. NO INJURY WAS REPORTED TO THE PATIENT. 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 21512333 ↗
• MalfunctionAug 12, 2024Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT THE TUFTEX OTW BALLOON WILL NOT DEFLATE. TO DEFLATE IT, THE USER POKED THE BALLOON WITH NEEDLE. NO INJURY WAS REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19965948 ↗
• MalfunctionFeb 28, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE TUFTEX OTW BALLOON WOULD NOT INFLATE IN THE PATIENT'S VESSEL AND WAS FOUND RUPTURED WHEN CHECKED. NO INJURY WAS REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18800740 ↗
• MalfunctionJan 16, 2024Material Rupture; Material Rupture

  LEAKAGE WAS DETECTED FROM THE BALLOON BEFORE CATHETER INSERTION. THE OPERATION WAS SUCCESSFULLY COMPLETED USING A REPLACEMENT. NO INJURY WAS REPORTED TO THE PATIENT. BASED ON THE INITIAL REPORT THIS EVENT WAS INITIALLY ASSESSED AS A NOT REPORTABLE INCIDENT. HOWEVER, UPON THE PHYSICAL EVALUATION OF THE DEVICE PERFORMED ON 21 DEC 2023, THE DAMAGE TO THE DEVICE WAS DETERMINED TO BE MORE SEVERE THAN INITIALLY REPORTED. THE BALLOON OF THE CATHETER WAS OBSERVED TO BE RUPTURED AND THE DEVICE APPEARED TO HAVE BEEN USED IN THE PROCEDURE. AS A RESULT, THIS IS NOW CONSIDERED A REPORTABLE EVENT WITH A NEW AWARENESS DATE OF 21 DEC 2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18519352 ↗
• MalfunctionJan 4, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED WHILE IT WAS INFLATED INSIDE THE VESSEL. THE CATHETER WAS REMOVED AND A REPLACEMENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. IT WAS STATED THAT A PRE-USE CHECK WAS NOT PERFORMED PRIOR TO THE DEVICE BEING USED. NO INJURY WAS REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18446360 ↗
• MalfunctionNov 21, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THE BALLOON RUPTURED DURING AN EMBOLECTOMY PROCEDURE. THE OPERATION WAS COMPLETED SUCCESSFULLY USING ANOTHER CATHETER. NO INJURY WAS REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18183209 ↗
• MalfunctionOct 20, 2023Material Rupture; Incomplete or Missing Packaging; Material Rupture; Incomplete or Missing Packaging

  IT WAS REPORTED THE PRODUCT DID NOT CONTAIN A SYRINGE AND A STOPCOCK. ALSO, THE BALLOON OF THIS CATHETER WAS RUPTURED DURING THE PREUSE TEST. THE OPERATION WAS SUCCESSFULLY COMPLETED USING A REPLACEMENT. NO INJURY WAS REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17974552 ↗
• MalfunctionAug 8, 2023Material Rupture; Material Rupture

  IT WAS REPORTED TUFTEX OVER-THE-WIRE EMBOLECTOMY CATHETER BALLOON (X2) DIDN'T INFLATE AFTER BEING INSERTED INTO THE PATIENT'S VESSEL. THE BALLOON WAS INSPECTED AND FOUND RUPTURED. NO INJURY WAS REPORTED TO THE PATIENT. NOTE: THIS IS REPORT 2 OF 2 RELATED TO THE SECOND CATHETER USED IN THE EVENT. REPORT 1220948-2023-00128 WAS SUBMITTED FOR THE FIRST DEVICE INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17485004 ↗
• MalfunctionMay 11, 2023Material Rupture; Material Rupture

  THE SECOND CATHETER WAS USED, BUT THE BALLOON ALSO RUPTURED. THERE WERE NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16911572 ↗
• MalfunctionMar 10, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  THE BALLOON WAS FOUND DAMAGED WHEN THE CATHETER WAS TAKEN OUT OF THE CASE. THE LATEX BALLOON WAS ONLY COVERED IN THE CENTER, AND IT WAS MISSING ANOTHER PART. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16523133 ↗
• MalfunctionFeb 15, 2023Material Rupture; Material Rupture

  A TUFTEX OVER-THE-WIRE EMBOLECTOMY CATHETER WAS BEING USED FOR CLOT REMOVAL. WHILE USING THE FIRST CATHETER, THE BALLOON RUPTURED. PLEASE NOTE REPORT 1220948-2023-00014 WAS REPORTED FOR THE FIRST DEVICE RELATED TO THIS INCIDENT. WHEN THE PROCEDURE WAS CONTINUED USING A SECOND CATHETER, THE BALLOON ALSO RUPTURED. THE PROCEDURE WAS COMPLETED USING A THIRD CATHETER. NO INJURY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16381736 ↗
• MalfunctionFeb 15, 2023Material Rupture; Material Rupture

  A TUFTEX OVER-THE-WIRE EMBOLECTOMY CATHETER WAS BEING USED FOR CLOT REMOVAL. AFTER INSERTING THE CATHETER INTO THE VESSEL THE BALLOON WAS INFLATED. WHEN THE CATHETER WAS WITHDRAWN, THE BALLOON RUPTURED. A SECOND CATHETER WAS USED TO CONTINUE THE PROCEDURE, HOWEVER THE BALLOON ALSO RUPTURED. PLEASE NOTE REPORT 1220948-2023-00015 WAS REPORTED FOR THE SECOND DEVICE RELATED TO THIS INCIDENT. THE PROCEDURE WAS COMPLETED USING A THIRD CATHETER. NO INJURY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16381735 ↗
• MalfunctionJan 11, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THE TUFTEX OTW EMBOLECTOMY CATHETER BALLOON BURST DURING USE ON THE PATIENT. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16140537 ↗
• MalfunctionNov 21, 2022Material Rupture; Material Rupture

  A TUFTEX OVER-THE-WIRE EMBOLECTOMY CATHETER WAS BEING USED TO REMOVE A THROMBUS. DURING PRE-USE CHECK THERE WERE NO ISSUES. AFTER INSERTING THE CATHETER INTO THE BLOOD VESSEL AND PULLING THE CATHETER FOR THE THROMBECTOMY THE BALLOON RUPTURED. ANOTHER PRODUCT WAS USED AS A SUBSTITUTE TO COMPLETE THE PROCEDURE. NO INJURY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15837800 ↗
• MalfunctionDec 10, 2021Material Rupture; Material Rupture

  THE COMMON CAROTID BALLOON RUPTURED DURING PRE-USE CHECK. SO, THE USER USED ANOTHER SHUNT FOR THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12980575 ↗
• MalfunctionDec 10, 2021Material Rupture; Material Rupture

  THE BALLOON OF THE TUFTEX OVER-THE-WIRE FAILED TO DEFLATE WHEN THE SURGEON ATTEMPTED TO DEFLATE IT INSIDE THE PATIENT'S VESSEL. AS A RESULT, THE BALLOON RUPTURED WHEN HE ATTEMPTED TO REMOVE THE CATHETER THROUGH THE INTRODUCER. HE HAD MADE TWO PASSES BEFORE ENCOUNTERING THIS ISSUE AND BOTH TIMES THE BALLOON DEFLATED PROPERLY. THERE WAS NO HARM TO THE PATIENT BECAUSE OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12980499 ↗
• MalfunctionMar 12, 2021Material Rupture; Material Rupture

  THE BALLOON OF THE OVER-THE-WIRE EMBOLECTOMY CATHETER RUPTURED DURING THROMBECTOMY. SURGEON USED ANOTHER OVER-THE-WIRE EMBOLECTOMY CATHETER TO COMPLETE THE PROCEDURE. THERE WAS NO HARM TO THE PATIENT AS THE RESULT OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11477781 ↗

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-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-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-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-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-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-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-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.
• 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.