LeMaitre Embolectomy Catheter 1651-34Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00840663100651), received between Sep 3, 2020 and Jan 19, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 19, 2026Material Separation

  IT WAS REPORTED THAT DURING AN AV SHUNT THROMBECTOMY, THE PHYSICIAN REPORTED FEELING AS THOUGH THE TIP OF THE CATHETER TORE WHILE IT WAS BEING WITHDRAWN. RESISTANCE WAS ENCOUNTERED DURING THE PROCEDURE; HOWEVER, IT WAS NECESSARY TO CONTINUE PULLING THE CATHETER. AS A RESULT, THE CATHETER TIP WAS RETRIEVED IN A PARTIALLY TORN CONDITION. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24109573 ↗
• MalfunctionSep 19, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE TUFTEX OTW BALLOON RUPTURED DURING PRE-USE CHECK. IT WAS NOT USED ON THE PATIENT. NO INJURY WAS REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20260484 ↗
• MalfunctionMay 5, 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 WHEN THE CATHETER WAS WITHDRAWN, THE BALLOON RUPTURED.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 16876276 ↗
• MalfunctionNov 21, 2022Material Rupture; Material Rupture

  A TUFTEX OVER-THE-WIRE EMBOLECTOMY CATHETER WAS BEING USED TO REMOVE A THROMBUS. PRIOR TO USE THE BALLOON INFLATED PROPERLY. THE CATHETER WAS INSERTED INTO THE VESSEL AND THE BALLOON RUPTURED WHEN PULLING THE CATHETER FOR THE THROMBECTOMY. ANOTHER DEVICE WAS USE TO COMPLETE THE OPERATION. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15838138 ↗
• MalfunctionMay 12, 2022Failure to Deflate; Failure to Deflate

  DURING THROMBECTOMY OF A HEMODIALYSIS PATIENT, THE SURGEON WAS UNABLE TO DEFLATE THE BALLOON OF THE TUFTEX EMBOLECTOMY CATHETER. SO, THE SURGEON TRIED DEFLATING THE BALLOON MULTIPLE TIMES BY ATTEMPTING TO ASPIRATE THE LIQUID INSIDE THE BALLOON USING A SYRINGE. AFTER REDUCING THE SIZE OF THE BALLOON TO A DESIRED SIZE, HE WITHDREW THE CATHETER FROM THE PATIENT'S VESSEL. THEN, HE USED ANOTHER CATHETER TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14380994 ↗
• 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 11477796 ↗
• MalfunctionDec 3, 2020Material Rupture; Material Rupture

  WHEN THE CATHETER SHAFT WAS INSERTED INTO THE BLOOD VESSEL AND THE BALLOON WAS INFLATED, THE BALLOON IMMEDIATELY RUPTURED. THERE WAS CALCIFICATION AT THE TREATMENT AREA. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER LEMAITRE OVER-THE-WIRE 4F EMBOLECTOMY CATHETER. THERE WAS NO INJURY TO THE PATIENT AS THE RESULT OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10938379 ↗
• MalfunctionSep 3, 2020Material Rupture; Material Rupture

  DURING THROMBECTOMY, WHEN SURGEON INFLATED THE BALLOON OF THE OVER-THE-WIRE EMBOLECTOMY CATHETER INSIDE THE PATIENT'S VESSEL, THE BALLOON RUPTURED. ANOTHER OVER-THE-WIRE EMBOLECTOMY CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO INJURY TO THE PATIENT AS THE RESULT OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10489547 ↗

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-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-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-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-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-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.