LeMaitre Embolectomy Catheter 1651-48Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00840663100682), received between Jul 13, 2017 and Sep 13, 2023 — classified as 1 injury, 14 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (8 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 13, 2023Leak/Splash; Material Separation; Leak/Splash; Material Separation

  IT WAS REPORTED THAT DURING USE THE FILL PORT OF THE CATHETER DETACHED FROM THE INJECTION BASE. IN ADDITION THE DISTAL TIP HAD LEAKAGE AROUND THE BALLOON WITH A RISK OF PART OF THE DEVICE DETACHING IN THE PATIENT. THE ISSUE OCCURRED WITH TWO DEVICES. NO INJURY WAS REPORTED TO THE PATIENT. ANOTHER CATHETER FROM THE SAME BATCH PRESENTED THE SAME PROBLEM. NOTE: THIS IS REPORT 2 OF 2 RELATED TO THE SECOND CATHETER USED IN THE EVENT. REPORT 1220948-2023-00146 WAS SUBMITTED FOR THE FIRST DEVICE INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17736683 ↗
• MalfunctionSep 13, 2023Leak/Splash; Material Separation; Leak/Splash; Material Separation

  IT WAS REPORTED THAT DURING USE THE FILL PORT OF THE CATHETER DETACHED FROM THE INJECTION BASE. IN ADDITION THE DISTAL TIP HAD LEAKAGE AROUND THE BALLOON WITH A RISK OF PART OF THE DEVICE DETACHING IN THE PATIENT. THE ISSUE OCCURRED WITH TWO DEVICES. NO INJURY WAS REPORTED TO THE PATIENT. ANOTHER CATHETER FROM THE SAME BATCH PRESENTED THE SAME PROBLEM. NOTE: THIS IS REPORT 1 OF 2 RELATED TO THE FIRST CATHETER USED IN THE EVENT. REPORT (B)(4) WAS SUBMITTED FOR THE SECOND DEVICE INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17736664 ↗
• MalfunctionJun 8, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING THE USE OF A TUFTEX OVER-THE-WIRE CATHETER, AFTER INSERTING THE CATHETER INTO THE VESSEL, THE BALLOON WAS INFLATED. WHEN THE CATHETER WAS WITHDRAWN FOR THROMBECTOMY, THE BALLOON WAS FOUND RUPTURED. A SECOND CATHETER WAS USED TO CONTINUE THE OPERATION BUT THE BALLOON ALSO RUPTURED. THE PROCEDURE WAS COMPLETED USING A THIRD CATHETER. NO INJURY OCCURRED. NOTE: THIS IS REPORT 1 OF 2 RELATED TO THE FIRST CATHETER USED IN THE EVENT. REPORT 1220948-2023-00093 WAS SUBMITTED FOR THE SECOND DEVICE INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17088813 ↗
• MalfunctionMay 5, 2023Material Rupture; Material Rupture

  WHEN CATHETER WAS INSERTED INTO BLOOD VESSEL AND BALLOON WAS INFLATED AT THE TARGET SITE, IT RUPTURED SOON AFTERWARDS. THERE WERE NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16876238 ↗
• MalfunctionJan 13, 2023Material Rupture; Material Rupture

  A TUFTEX OVER-THE-WIRE EMBOLECTOMY CATHETER WAS BEING USED IN A PROCEDURE. DURING USE THE BALLOON RUPTURED ANOTHER DEVICE WAS USE TO COMPLETE THE OPERATION. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16157455 ↗
• MalfunctionDec 8, 2022Material Rupture; Material Rupture

  A TUFTEX OVER-THE-WIRE EMBOLECTOMY CATHETER WAS BEING USED FOR A THROMBECTOMY. THE PHYSICIAN NOTICED THAT THE BALLOON HAD CRACKED. ANOTHER DEVICE WAS USE TO COMPLETE THE OPERATION. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15940303 ↗
• MalfunctionFeb 25, 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 BLOOD VESSEL. THE SURGEON THEN USED ANOTHER CATHETER TO COMPLETE THE PROCEDURE. THERE WAS NO IMPACT ON THE PATIENT BECAUSE OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13598837 ↗
• MalfunctionJul 7, 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 12131874 ↗
• MalfunctionJun 16, 2021Deflation Problem; Deflation Problem

  DURING THROMBECTOMY IN A DIALYSIS PATIENT, THE SURGEON INSERTED THE CATHETER SHAFT INTO THE BLOOD VESSEL. HE INFLATED THE BALLOON TO REMOVE THE THROMBUS. WHEN HE TRIED TO DEFLATE THE BALLOON JUST BEFORE THE STENOSIS, HE WAS UNABLE TO DO SO. THERE WAS NO HARM TO THE PATIENT AS A RESULT OF THIS INCIDENT. THE SURGEON USED ANOTHER 4F OVER-THE-WIRE EMBOLECTOMY CATHETER TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12010279 ↗
• MalfunctionMar 26, 2021Inflation Problem; Inflation Problem

  DURING PRE-USE CHECK, WHEN SURGEON INFLATED THE BALLOON OF THE OVER THE WIRE EMBOLECTOMY CATHETER, HE OBSERVED THE TIP OF THE BALLOON INFLATED IN A DISTORTED SHAPE. HE ALSO EXPERIENCED EXCESSIVE RESISTANCE WHEN INFLATING THE BALLOON. THE MALFUNCTION WAS FOUND DURING PRE-USE CHECK. SURGEON USED ANOTHER OVER-THE-WIRE EMBOLECTOMY CATHETER TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11578315 ↗
• MalfunctionNov 20, 2020Deflation Problem; Deflation Problem

  AFTER PREUSE CHECK, THE CATHETER WAS INSERTED INTO THE VESSEL. THEN, THE BALLOON WAS INFLATED BY THE SALINE. DURING THE THROMBECTOMY (THE EXACT NUMBER OF TIMES CATHETER WAS USED TO REMOVE THE CLOTS WAS UNKNOWN), THE BALLOON ATTEMPTED TO DEFLATE, BUT IT COULD NOT DO. THE CATHETER WAS REMOVED FROM THE BLOOD VESSEL WITH THE STATUS OF INFLATED BALLOON. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10878568 ↗
• MalfunctionJul 1, 2020Material Rupture; Material Rupture

  DURING AN EMBOLECTOMY PROCEDURE, THE BALLOON OF AN OVER-THE-WIRE EMBOLECTOMY CATHETER RUPTURED WHEN SURGEON ATTEMPTED TO REMOVE A CLOT FROM THE PATIENT'S VESSEL. THERE WAS NO INJURY TO THE PATIENT AS THE RESULT OF THIS INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10221054 ↗
• MalfunctionFeb 19, 2020Material Rupture; Material Rupture

  DURING AN EMBOLECTOMY PROCEDURE, THE BALLOON OF A OVER-THE-WIRE EMBOLECTOMY CATHETER BURST WHEN SURGEON ATTEMPTED TO REMOVE A CLOT FROM THE PATIENT'S SUPERFICIAL FEMORAL ARTERY. THERE WAS NO INJURY TO THE PATIENT AS THE RESULT OF THIS INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9729588 ↗
• InjuryNov 20, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING THROMBECTOMY OF A PTFE GRAFT, SURGEON INITIALLY INSERTED A LEMAITRE SINGLE LUMEN EMBOLECTOMY CATHETER TO REMOVE AN OLD THROMBUS FROM THE PATIENT'S FEMORAL ARTERY. HOWEVER, HE COULD NOT GET THE CATHETER PAST THE THROMBUS. USING A GUIDEWIRE, HE WAS ABLE TO INSERT A LEMAITRE OVER-THE-WIRE EMBOLECTOMY CATHETER PAST THE THROMBUS. WHEN PULLING THE THROMBUS, SURGEON EXPERIENCED STRONG RESISTANCE AT THE ANASTOMOTIC AREA BETWEEN THE ARTERY AND PTFE. SO, HE EXERTED GREATER PULL FORCE TO REMOVE THE THROMBUS. BY DOING SO, HE WAS ABLE TO REMOVE THE CATHETER. HOWEVER, THE CATHETER WAS MISSING THE BALLOON. HE THEN USED ANOTHER EMBOLECTOMY CATHETER ( FROM A DIFFERENT MANUFACTURER ) TO REMOVE THE THROMBUS AND THE DISLODGED BALLOON. THERE WAS NO INJURY TO THE PATIENT AS THE RESULT OF THIS INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9350808 ↗
• MalfunctionJul 13, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  WHILE PERFORMING EMBOLECTOMY, THE DISTAL TIP SEPARATED FROM THE CATHETER.

  Patient problems: No Information

  MAUDE report 6712387 ↗

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-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-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-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-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-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-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.