LeMaitre Embolectomy Catheter 1651-44Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00840663100675), received between Nov 29, 2018 and Dec 12, 2023 — classified as 38 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (24 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 25 most recent of 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2023Failure to Deflate; Failure to Deflate

  THE CATHETER WAS REMOVED FROM THE PACKAGING AND PREPARED. NORMAL SALINE WAS INJECTED INTO THE BALLOON TO REMOVE AIR. THE BALLOON WAS INFLATED, BUT THERE WAS STRONG RESISTANCE. THE BALLOON WAS ATTEMPTED TO BE DEFLATED, BUT IT DID NOT DEFLATE. THEREFORE, THE PHYSICIAN DID NOT USE THIS CATHETER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER CATHETER OF THE SAME SIZE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18315751 ↗
• MalfunctionDec 5, 2023Material Rupture; Material Rupture

  IT WAS REPORTED AFTERR THE BALLOON WAS INFLATED IN THE BLOOD VESSEL, IT RUPTURED AFTER ATTEMPTING TO REMOVE IT. THE OPERATION WAS COMPLETED SUCCESSFULLY USING ANOTHER DEVICE. NO INJURY WAS REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18271804 ↗
• MalfunctionOct 13, 2023Failure to Deflate; Failure to Deflate

  IT WAS REPORTED WHEN ATTEMPTING TO REMOVE THE CATHETER FROM THE BLOOD VESSEL DURING THROMBUS REMOVAL, THE BALLOON COULD NOT BE DEFLATED. THE OPERATION CONTINUED USING A REPLACEMENT AND WAS COMPLETED SUCCESSFULLY. NO INJURY WAS REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17932129 ↗
• MalfunctionSep 19, 2023Material Rupture; Material Rupture

  IT WAS REPORT THE BALLOON RUPTURED DURING THE INITIAL THROMBECTOMY PROCEDURE. 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 17776763 ↗
• MalfunctionSep 6, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THE BALLOON RUPTURED WHILE REMOVING A CLOT DURING AN EMBOLECTOMY PROCEDURE AT THE STENOTIC REGIONS. THE BALLOON WAS NOT PUNCTURED WITH A SHARP OBJECT. NO UNINTENDED FRAGMENT WAS LEFT INSIDE THE PATIENT'S VESSEL. NO INJURY WAS REPORTED TO THE PATIENT. THE OPERATION WAS COMPLETED SUCCESSFULLY USING ANOTHER 1651-44J.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17693945 ↗
• MalfunctionJun 29, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THE TUFTEX OVER-THE-WIRE EMBOLECTOMY CATHETER BALLOON RUPTURED WHILE ATTEMPTING TO REMOVE IT FROM THE VESSEL. NO INJURY REPORTED TO PATIENT. THE OPERATION WAS COMPLETED SUCCESSFULLY USING ANOTHER TUFTEX OVER-THE-WIRE EMBOLECTOMY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17227160 ↗
• MalfunctionJun 8, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING THE USE OF A TUFTEX OVER-THE-WIRE CATHTER, AFTER INSERTING THE CATHETER INTO THE VESSEL, THE BALLOON WAS INFLATED. THE FIRST CATHETER USED IN THE PROCEDURE EXPERIENCED A BALLOON RUPTURE. A SECOND CATHETER WAS THEN USED, BUT AS THE CATHETER WAS WITHDRAWN FOR THROMBECTOMY, THE BALLOON ALSO RUPTURED. THE PROCEDURE WAS COMPLETED USING A THIRD CATHETER. NO INJURY OCCURRED. NOTE: THIS IS REPORT 2 OF 2 RELATED TO THE SECOND CATHETER USED IN THE EVENT. REPORT 1220948-2023-00088 WAS SUBMITTED FOR THE SECOND DEVICE INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17088814 ↗
• MalfunctionMay 11, 2023Material Rupture; Material Rupture

  AFTER INSERTING THE CATHETER INTO THE VESSEL, THE BALLOON WAS INFLATED. WHEN THE CATHETER WAS WITHDRAWN, THE BALLOON RUPTURED. THERE WERE NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16911569 ↗
• MalfunctionMar 2, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT AFTER INSERTING THE TUFTEX OVER-THE-WIRE EMBOLECTOMY CATHETER INTO THE VESSEL THE BALLOON WAS INFLATED. WHEN THE CATHETER WAS WITHDRAWN THE BALLOON RUPTURED. NO INJURY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16469675 ↗
• MalfunctionJan 18, 2023Separation Problem; Separation Problem

  IT WAS REPORTED THAT DURING THE PRE-USE CHECK, THE TUFTEX OTW EMBOLECTOMY CATHETER BALLOON CAME OFF FROM THE CATHETER. NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16195168 ↗
• MalfunctionSep 20, 2022Material Rupture; Material Rupture

  THE SURGEON STATED THAT WHILE USING THE TUFTEX OVER-THE-WIRE EMBOLECTOMY CATHETER, THE BALLOON WAS RUPTURED WHILE REMOVING A CLOT. THE DEVICE HAD BEEN CHECKED BEFORE USE AND THE BALLOON WAS ABLE TO INFLATE WITHOUT LEAKAGE. THE RECOMMENDED VOLUME OF SALINE WAS NOT EXCEEDED. THE SURGEON BELIEVES THAT THE CATHETER WAS USED AT A STENOTIC REGION. NO BALLOON FRAGMENTS WERE LEFT IN THE PATIENT'S VESSEL. THE OPERATION WAS COMPLETED SUCCESSFULLY USING ANOTHER PRODUCT. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15457741 ↗
• MalfunctionSep 14, 2022Material Deformation; Material Deformation

  THE SURGEON STATED THAT WHILE USING THE TUFTEX OVER-THE-WIRE EMBOLECTOMY CATHETER, THE SHAFT WAS STRETCHED DURING THE EMBOLECTOMY, SO THE PHYSICIAN STOPPED USING THIS PRODUCT FOR THE OPERATION. THE OPERATION WAS COMPLETED SUCCESSFULLY USING ANOTHER PRODUCT. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15421664 ↗
• MalfunctionJul 21, 2022Failure to Deflate; Failure to Deflate

  ACCORDING TO THE SURGEON, THE BALLOON OF THE TUFTEX OVER-THE-WIRE EMBOLECTOMY CATHETER RUPTURED DURING AN EMBOLECTOMY PROCEDURE. HE OBSERVED THE LIGATURE WAS LOOSE AND THE BALLOON WAS DEFORMED WHEN IT WAS REMOVED FROM THE PATIENT'S VESSEL. THERE WAS NO HARM TO THE PATIENT BECAUSE OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15079778 ↗
• MalfunctionJun 10, 2022Failure to Deflate; Failure to Deflate

  ACCORDING TO THE SURGEON, THE BALLOON OF THE TUFTEX OVER-THE-WIRE EMBOLECTOMY CATHETER SLIPPED DURING AN EMBOLECTOMY PROCEDURE. THERE WAS NO HARM TO THE PATIENT BECAUSE OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14657358 ↗
• MalfunctionJun 8, 2022Deflation Problem

  THE BALLOON OF THE TUFTEX OVER-THE-WIRE EMBOLECTOMY CATHETER FAILED TO DEFLATE DURING AN EMBOLECTOMY PROCEDURE. THERE WAS NO HARM TO THE PATIENT BECAUSE OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14634437 ↗
• MalfunctionFeb 18, 2022Material Rupture; Material Rupture

  THE BALLOON OF THE TUFTEX OVER-THE-WIRE EMBOLECTOMY CATHETER BURST DURING AN EMBOLECTOMY PROCEDURE. THERE WAS NO HARM TO THE PATIENT BECAUSE OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13562222 ↗
• MalfunctionJan 5, 2022Material Rupture; Material Rupture

  THE BALLOON OF THE TUFTEX OVER-THE-WIRE EMBOLECTOMY CATHETER FAILED TO DEFLATE DURING AN EMBOLECTOMY PROCEDURE SO, THE SURGEON REMOVED THE CATHETER WITH THE BALLOON IN AN INFLATED STATE FROM THE PATIENT'S ARTIFICIAL BLOOD VESSEL. THE SURGEON THEN USED ANOTHER CATHETER TO COMPLETE THE PROCEDURE. THERE WAS NO IMPACT ON THE PATIENT'S HEALTH BECAUSE OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13172490 ↗
• MalfunctionDec 30, 2021Material Rupture; Material Rupture

  THE BALLOON OF THE TUFTEX OVER-THE-WIRE EMBOLECTOMY CATHETER FAILED TO DEFLATE DURING THE PRE-USE CHECK. SO, THE SURGEON USED ANOTHER CATHETER FOR THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13120320 ↗
• MalfunctionNov 30, 2021Material Rupture; Material Rupture

  THE BALLOON OF THE TUFTEX OVER-THE-WIRE EMBOLECTOMY CATHETER RUPTURED DURING AN EMBOLECTOMY PROCEDURE. SURGEON THEN USED ANOTHER TUFTEX OVER-THE-WIRE EMBOLECTOMY 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 12897253 ↗
• MalfunctionJul 20, 2021Material Rupture; Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12199412 ↗
• MalfunctionJul 14, 2021Material Rupture; Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12165666 ↗
• MalfunctionJun 18, 2021Material Rupture; Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12026426 ↗
• MalfunctionJun 11, 2021Material Rupture; Material Rupture

  THIS IS REPORT 1 OF 2. THE BALLOON OF THE 4F OVER-THE-WIRE EMBOLECTOMY CATHETER RUPTURED DURING AN EMBOLECTOMY PROCEDURE. SO, SURGEON USED ANOTHER 4F OVER-THE-WIRE EMBOLECTOMY CATHETER FOR THE OPERATION IMMEDIATELY. BUT, THE BALLOON OF THIS CATHETER ALSO RUPTURED DURING THE PROCEDURE. THE SURGEON THEN USED A 5F PLUS OVER-THE-WIRE EMBOLECTOMY CATHETER AND WAS ABLE TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO HARM TO THE PATIENT AS A RESULT OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11986261 ↗
• MalfunctionJun 11, 2021Material Rupture; Material Rupture

  THIS IS REPORT 2 OF 2. THE BALLOON OF THE 4F OVER-THE-WIRE EMBOLECTOMY CATHETER RUPTURED DURING AN EMBOLECTOMY PROCEDURE. SO, SURGEON USED ANOTHER 4F OVER-THE-WIRE EMBOLECTOMY CATHETER FOR THE OPERATION IMMEDIATELY. BUT, THE BALLOON OF THIS CATHETER ALSO RUPTURED DURING THE PROCEDURE. THE SURGEON THEN USED A 5F PLUS OVER-THE-WIRE EMBOLECTOMY CATHETER AND WAS ABLE TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO HARM TO THE PATIENT AS A RESULT OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11986248 ↗
• MalfunctionJun 4, 2021Material Rupture; Material Rupture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11942332 ↗

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-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-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-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-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.