LeMaitre Embolectomy Catheter e1651-84Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00840663100859), received between May 30, 2019 and Jul 13, 2023 — classified as 14 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 13, 2023Material Rupture; Material Rupture

  IT WAS REPORTED FOUR TUFTEX OTW CATHETERS HAD BALLOON RUPTURE DURING DECLOT - DIALYSIS ACCESS PROCEDURE (2 BY EACH SURGEON) FOR END STAGE RENAL DISEASE DURING FIRST PASS. NO INJURY OCCURRED TO PATIENT. CATHETERS WERE DISCARDED AND NEW EMBOLECTOMY CATHETER WAS USED. THIS IS REPORT 3 OF 4 RELATED TO THE THIRD CATHETER USED IN THE EVENT. REPORT 1220948-2023-00116, 1220948-2023-00117, 1220948-2023-00119 WERE SUBMITTED FOR THE FIRST, SECOND, AND FOURTH DEVICES INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17320636 ↗
• MalfunctionJul 13, 2023Material Rupture; Material Rupture

  IT WAS REPORTED FOUR TUFTEX OTW CATHETERS HAD BALLOON RUPTURE DURING DECLOT - DIALYSIS ACCESS PROCEDURE (2 BY EACH SURGEON) FOR END STAGE RENAL DISEASE DURING FIRST PASS. NO INJURY OCCURRED TO PATIENT. CATHETERS WERE DISCARDED AND NEW EMBOLECTOMY CATHETER WAS USED. THIS IS REPORT 4 OF 4 RELATED TO THE FOURTH CATHETER USED IN THE EVENT. REPORT 1220948-2023-00116, 1220948-2023-00117, 1220948-2023-00118 WERE SUBMITTED FOR THE FIRST, SECOND, AND THIRD DEVICES INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17320108 ↗
• MalfunctionJul 13, 2023Material Rupture; Material Rupture

  IT WAS REPORTED FOUR TUFTEX OTW CATHETERS HAD BALLOON RUPTURE DURING DECLOT - DIALYSIS ACCESS PROCEDURE (2 BY EACH SURGEON) FOR END STAGE RENAL DISEASE DURING FIRST PASS. NO INJURY OCCURRED TO PATIENT. CATHETERS WERE DISCARDED AND NEW EMBOLECTOMY CATHETER WAS USED. THIS IS REPORT 1 OF 4 RELATED TO THE FIRST CATHETER USED IN THE EVENT. REPORT 1220948-2023-00117, 1220948-2023-00118, 1220948-2023-00119 WERE SUBMITTED FOR THE SECOND, THIRD, AND FOURTH DEVICES INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17319592 ↗
• MalfunctionMar 24, 2020Deflation Problem; Nonstandard Device; Deflation Problem

  DURING A THROMBECTOMY PROCEDURE, THE BALLOON OF AN OVER-THE-WIRE EMBOLECTOMY CATHETER FAILED TO DEFLATE. THE BALLOON BURST WHEN SURGEON ATTEMPTED 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 9875471 ↗
• MalfunctionMar 11, 2020Deflation Problem; Deflation Problem

  DURING A THROMBECTOMY PROCEDURE, THE BALLOON OF AN OVER-THE-WIRE EMBOLECTOMY CATHETER FAILED TO DEFLATE AFTER PULLING THE ARTERIAL PLUG INTO THE GRAFT. SO, THE SURGEON PUNCTURED THE BALLOON AND REMOVED THE CATHETER FROM THE PATIENT'S VESSEL. THERE WAS NO INJURY TO THE PATIENT AS THE RESULT OF THIS INCIDENT. THIS IS REPORT 3 OF 5.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9817823 ↗
• MalfunctionMar 11, 2020Deflation Problem; Deflation Problem

  DURING A THROMBECTOMY PROCEDURE, THE BALLOON OF AN OVER-THE-WIRE EMBOLECTOMY CATHETER FAILED TO DEFLATE AFTER PULLING THE ARTERIAL PLUG INTO THE GRAFT. SO, THE SURGEON PUNCTURED THE BALLOON AND REMOVED THE CATHETER FROM THE PATIENT'S VESSEL. THERE WAS NO INJURY TO THE PATIENT AS THE RESULT OF THIS INCIDENT. THIS IS REPORT 1 OF 5.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9817819 ↗
• MalfunctionMar 11, 2020Deflation Problem; Deflation Problem

  DURING A THROMBECTOMY PROCEDURE, THE BALLOON OF AN OVER-THE-WIRE EMBOLECTOMY CATHETER FAILED TO DEFLATE AFTER PULLING THE ARTERIAL PLUG INTO THE GRAFT. SO, THE SURGEON PUNCTURED THE BALLOON AND REMOVED THE CATHETER FROM THE PATIENT'S VESSEL. THERE WAS NO INJURY TO THE PATIENT AS THE RESULT OF THIS INCIDENT. THIS IS REPORT 4 OF 5.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9817818 ↗
• MalfunctionMar 11, 2020Deflation Problem; Nonstandard Device; Deflation Problem

  DURING A THROMBECTOMY PROCEDURE, THE BALLOON OF AN OVER-THE-WIRE EMBOLECTOMY CATHETER FAILED TO DEFLATE AFTER PULLING THE ARTERIAL PLUG INTO THE GRAFT. SO, THE SURGEON PUNCTURED THE BALLOON AND REMOVED THE CATHETER FROM THE PATIENT'S VESSEL. THERE WAS NO INJURY TO THE PATIENT AS THE RESULT OF THIS INCIDENT. THIS IS REPORT 1 OF 5.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9817816 ↗
• MalfunctionMar 11, 2020Deflation Problem; Deflation Problem

  DURING A THROMBECTOMY PROCEDURE, THE BALLOON OF AN OVER-THE-WIRE EMBOLECTOMY CATHETER FAILED TO DEFLATE AFTER PULLING THE ARTERIAL PLUG INTO THE GRAFT. SO, THE SURGEON PUNCTURED THE BALLOON AND REMOVED THE CATHETER FROM THE PATIENT'S VESSEL. THERE WAS NO INJURY TO THE PATIENT AS THE RESULT OF THIS INCIDENT. THIS IS REPORT 5 OF 5.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9817815 ↗
• MalfunctionMar 10, 2020Deflation Problem; Deflation Problem

  DURING A THROMBECTOMY PROCEDURE, THE BALLOON OF A OVER-THE-WIRE EMBOLECTOMY CATHETER FAILED TO DEFLATE AFTER PULLING THE ARTERIAL PLUG INTO THE GRAFT. SO, THE SURGEON PUNCTURED THE BALLOON AND REMOVED THE CATHETER 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 9811062 ↗
• MalfunctionJan 3, 2020Material Rupture; Material Rupture

  DURING PRE-USE CHECK, THE BALLOON OF OVER-THE-WIRE EMBOLECTOMY CATHETER RUPTURED WHEN THE BALLOON WAS INFLATED WITH SALINE. DEVICE WAS NOT USED IN THE PATIENT. THIS IS REPORT 2 FO 4.

  Patient problems: No Patient Involvement

  MAUDE report 9549080 ↗
• MalfunctionJan 3, 2020Material Rupture; Material Rupture

  DURING PRE-USE CHECK, THE BALLOON OF OVER-THE-WIRE EMBOLECTOMY CATHETER RUPTURED WHEN THE BALLOON WAS INFLATED WITH SALINE. DEVICE WAS NOT USED IN THE PATIENT. THIS IS REPORT 3 FO 4.

  Patient problems: No Patient Involvement

  MAUDE report 9549068 ↗
• MalfunctionJan 3, 2020Material Rupture; Material Rupture

  DURING THROMBECTOMY, THE BALLOON OF OVER-THE-WIRE EMBOLECTOMY CATHETER RUPTURED WHEN SURGEON ATTEMPTED TO REMOVE THE CLOT BY PULLING IT THROUGH THE INFLATED BALLOON OF THIS CATHETER. THERE WAS NO INJURY TO THE PATIENT AS THE RESULT OF THIS INCIDENT. THIS IS REPORT 1 OF 4.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9548998 ↗
• MalfunctionMay 30, 2019Material Rupture; Material Rupture

  DURING THROMBECTOMY OF AV GRAFT, THE BALLOON OF THE OVER-THE-WIRE EMBOLECTOMY CATHETER BURST. NO FURTHER INFORMATION WAS PROVIDED. THERE WAS NO INJURY TO THE PATIENT AS THE RESULT OF THIS INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8656308 ↗

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-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-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-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-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-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.