LeMaitre Embolectomy Catheter 1601-38Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00840663100477), received between Aug 26, 2016 and Apr 29, 2026 — classified as 5 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (4 reports).

9 other recalls cover devices cleared under the same FDA submission (K992368); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2026Material Rupture

  IT WAS REPORTED THAT THE TUFTEX EMBOLECTOMY CATHETER BALLOON WAS FOUND RUPTURED UPON REMOVAL FROM DISPENSER. THE DEVICE WAS NOT USED ON THE PATIENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25030900 ↗
• MalfunctionFeb 27, 2026Failure to Deflate

  WHILE PREPARING THE DEVICE, THE BALLOON COULD BE INFLATED. HOWEVER, IT COULD NOT BE DEFLATED. A DIFFERENT DEVICE OF THE SAME SIZE AND FROM THE SAME LOT WAS USED AS A REPLACEMENT. THE PROCEDURE WAS COMPLETED WITHOUT ISSUE USING THE REPLACEMENT DEVICE. NO PATIENT INJURY OR ADVERSE HEALTH EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24468739 ↗
• MalfunctionNov 16, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING A PROCEDURE USING A TUFTEX EMBOLECTOMY CATHETER THE INITIAL CATHETER BECAME IMMENSELY ELONGATED WHILE BEING REMOVED FROM THE PATIENT. AFTER THE FIRST DEVICE WAS REMOVED, A SECOND DEVICE WAS USED WHERE THE BALLOON OF THE CATHETER RUPTURED DURING USE. NO INJURY OCCURRED. PLEASE NOTE THAT REPORT 1220948-2022-00116 WAS ALSO SUBMITTED RELATED TO THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15807238 ↗
• MalfunctionNov 20, 2019Material Rupture; Material Rupture

  DURING THROMBECTOMY OF A PTFE GRAFT, SURGEON INSERTED A LEMAITRE SINGLE LUMEN EMBOLECTOMY CATHETER TO REMOVE AN OLD THROMBUS FROM THE PATIENT'S FEMORAL ARTERY. HOWEVER, HE FOUND THAT THE BALLOON HAD ALREADY RUPTURED. THERE WAS NO INJURY TO THE PATIENT AS THE RESULT OF THIS INCIDENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9350800 ↗
• MalfunctionOct 18, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING AN EMBOLECTOMY PROCEDURE IN A POPLITEAL ARTERY, THE BALLOON OF THE EMBOLECTOMY CATHETER DISLODGED FROM THE CATHETER SHAFT AND WAS RETAINED IN THE PATIENT'S BLOOD VESSEL. SURGEON HAD TO PERFORM ADDITIONAL SURGERY TO RETRIEVE THE DISLODGED BALLOON. NO FURTHER INFORMATION WAS PROVIDED BY THE SURGICAL TEAM.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 9210120 ↗
• MalfunctionJun 14, 2019Unintended Movement; Unintended Movement

  DURING AN EMERGENCY VASCULAR PROCEDURE, WHILE PERFORMING A LEFT POPLITEAL EMBOLECTOMY, THE TIP OF THE EMBOLECTOMY CATHETER AND THE BALLOON BROKE OFF THE CATHETER AND WAS RETAINED IN THE PATIENT'S BLOOD VESSEL. MULTIPLE ATTEMPTS WERE MADE BY THE SURGEON TO LOCATE AND RETRIEVE THE MISSING TIP, BUT WERE UNSUCCESSFUL. THE CATHETER TIP REMAINED IN SITU.

  Patient problems: Foreign Body In Patient

  MAUDE report 8700809 ↗
• InjuryDec 13, 2018Difficult to Remove; Difficult to Remove

  A (B)(6) YEARS OLD MALE PATIENT WITH OBSTRUCTIVE HYDROCEPHALUS UNDERWENT VENTRICULOSTOMY PROCEDURE USING LEMAITRE EMBOLECTOMY CATHETER CATALOG# 1601-38, LOT# SLC4326. THE PHYSICIAN WAS UNABLE TO REMOVE THE CATHETER FROM THE VENTRICLE, AND THE CATHETER WAS DAMAGED WHILE REMOVING IT. SO, ANOTHER CATHETER WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: Hydrocephalus

  MAUDE report 8162163 ↗
• MalfunctionDec 13, 2018Difficult to Remove; Difficult to Remove

  DURING NEUROENDOSCOPY, THE BALLOON OF THE LEMAITRE EMBOLECTOMY CATHETER CATALOG# 1601-38 LOT# SLC4470 FAILED TO DEFLATE IN A NEUROENDOSCOPE. AS A RESULT, THE SURGEON COULD NOT REMOVE THE CATHETER THROUGH THE NEUROENDOSCOPE CHANNEL . SO, HE HAD TO REMOVE ALL OF THE OTHER EQUIPMENT IN ORDER TO REMOVE THE CATHETER.

  Patient problems: No Information

  MAUDE report 8162160 ↗
• InjuryOct 28, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING A THROMBECTOMY PROCEDURE, WHILE REMOVING THE THROMBUS, THE CATHETER CAME OUT OF THE ARTERY BUT THE BALLOON ATTACHED TO THE CATHETER WAS MISSING.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8011480 ↗
• MalfunctionSep 21, 2018Deflation Problem; Deflation Problem

  THE INITIAL REPORT RECEIVED FROM THE SURGEON STATED THAT THE HUB JOINT WAS LEAKING DURING PRE-USE CHECK. DURING OUR EVALUATION, WE OBSERVED THAT THE BALLOON INFLATED PARTIALLY BUT FAILED TO DEFLATE.

  Patient problems: No Information

  MAUDE report 7899713 ↗
• MalfunctionSep 13, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING REMOVAL OF THROMBUS FROM THE FISTULA AT THE LEFT ARM, LEMAITRE EMBOLECTOMY CATHETER WAS INSERTED AND THE BALLOON WAS INFLATED WITH APPROXIMATELY 0.2 ML OF HEPARINIZED SALINE. WHILE PULLING THE THROMBUS OUT OF THE VESSEL, THE BALLOON SNAGGED AT THE ELBOW. SO, THE PHYSICIAN DEFLATED THE BALLOON SLIGHTLY AND THEN CONTINUED TO WITHDRAW THE CATHETER. WHEN THE CATHETER WAS REMOVED COMPLETELY FROM THE PATIENT'S VESSEL, HE FOUND OUT THAT THE BALLOON WAS MISSING FROM THE CATHETER.

  Patient problems: Alteration In Body Temperature

  MAUDE report 7874858 ↗
• InjuryJun 22, 2018Material Rupture

  THIS IS REPORT 2 OF 2 (PLEASE REFER TO 1220948-2018-00040 FOR ANOTHER REPORT). BALLOON RUPTURED DURING THE EMBOLECTOMY PROCEDURE.

  Patient problems: No Information

  MAUDE report 7631227 ↗
• InjuryJun 22, 2018Device Slipped; Device Slipped

  THIS IS REPORT 1 OF 2 (PLEASE REFER TO 1220948-2018-00041 FOR ANOTHER REPORT). CATHETER BALLOON DETACHED COMPLETELY FROM THE CATHETER SHAFT DURING THE EMBOLECTOMY PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7631223 ↗
• InjuryApr 12, 2018Deflation Problem; Deflation Problem

  THE CATHETER WAS STUCK UPON ENTERING A COLLATERAL VARIANT OF THE SUPERFICIAL FEMORAL ARTERY BECAUSE THE BALLOON DID NOT DEFLATE. IT WAS INITIALLY NOT POSSIBLE TO REMOVE THE BALLOON, EVEN AFTER PUNCTURING IT. IT WAS NECESSARY TO DRY THE COLLATERAL VARIANT TO REMOVE THE CATHETER.

  Patient problems: Foreign Body In Patient

  MAUDE report 7426568 ↗
• MalfunctionNov 22, 2017Detachment Of Device Component; Detachment Of Device Component

  DURING A FEMORAL ARTERY EMBOLECTOMY PROCEDURE, THE BALLOON OF THE EMBOLECTOMY CATHETER RUPTURED AND SHEARED AWAY FROM THE CATHETER. THE TIP WAS NOT RETRIEVED FROM THE PATIENTS VESSEL.

  Patient problems: Foreign Body In Patient

  MAUDE report 7053876 ↗
• MalfunctionAug 26, 2016Detachment Of Device Component; Detachment Of Device Component

  PATIENT HAD AN ACUTE RUPTURE OF THE AORTA, ONCE BROUGHT UNDER CONTROL AND REPAIRED. THE SURGEON USED A 4FR AND THEN A 3FR EMBOLECTOMY CATHETER TO REMOVE DEBRIS FROM THE ILIAC, SFA AND EVENTUALLY THE PROXIMAL POPLITEAL. IT WAS AFTER REMOVING THE 3FR CATHETER FROM THE CALCIFIED DISTAL VESSEL THAT HE NOTICED THE BALLOON/END OF THE 3FR CATHETER WAS MISSING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5906302 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K992368. One submission often covers many models, so check the product and lot details in each record.

• Z-0228-2023 · Sep 30, 2022 · Open, Classified
  TufTex Embolectomy Catheter, Model No. This catheter has a latex balloon and a single lumen extrusion. It is inserted using a guidewire or introducer. The devices affected by thi
• Z-0388-2016 · Oct 21, 2015 · Terminated
  LeMaitre Single Lumen Embolectomy Catheter 5F, 80 cm, Model 1601-58 and e1601-58. Indicated for the removal of arterial emboli and thrombi.
• Z-0387-2016 · Oct 21, 2015 · Terminated
  LeMaitre Single Lumen Embolectomy Catheter 4F, 80 cm, Model 1601-48 and e1601-48. Indicated for the removal of arterial emboli and thrombi.
• Z-0390-2016 · Oct 21, 2015 · Terminated
  LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 2F, 60 cm, Model e1801-26. Indicated for the removal of arterial emboli and thrombi.
• Z-0389-2016 · Oct 21, 2015 · Terminated
  LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 6F, 80 cm, Model 1601-68. Indicated for the removal of arterial emboli and thrombi.
• Z-0386-2016 · Oct 21, 2015 · Terminated
  LeMaitre Single Lumen Embolectomy Catheter 3F, 80 cm, Model 1601-38 and e1601-38. Indicated for the removal of arterial emboli and thrombi.
• Z-0558-05 · Feb 7, 2005 · Terminated
  LeMaitre Embolectomy Catheter 3F Single Lumen, Balloon volume 0.2ml, Length 80 cm, Latex Model: 1601-38
• Z-0560-05 · Feb 7, 2005 · Terminated
  LeMaitre Embolectomy Catheter 5F Single Lumen, Balloon Volume 1.5 ml, Length 80 cm, Latex Model: 1601-58
• Z-0557-05 · Feb 7, 2005 · Terminated
  LeMaitre Embolectomy Catheter 2F Single Lumen, Balloon Volume 0.05 ml, Length 60 cm. Latex Model: 1601-26