LeMaitre Embolectomy Catheter 1601-48Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00840663100491), received between Nov 28, 2017 and Apr 3, 2026 — classified as 1 injury, 23 malfunctions.

The most frequently reported specific device problem is “Failure to Deflate” (11 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2026Material Separation

  IT WAS REPORTED THAT THE CATHETER WAS USED TO UNCLOG A BYPASS. DURING WITHDRAWAL, THE CATHETER HEAD DETACHED AND REMAINED ABOVE THE STENOSIS. A SECOND DEVICE WAS USED TO SUCCESSFULLY RETRIEVE THE DETACHED COMPONENT. THE DEVICE WAS NOT PRE-CHECKED PRIOR TO USE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24775120 ↗
• MalfunctionNov 26, 2024Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT THE TUFTEX EMBOLECTOMY CATHETER BALLOON DID NOT DEFLATE DURING A PROCEDURE. NO INJURY WAS REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20785836 ↗
• MalfunctionNov 26, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THIS TUFTEX 4F WAS THE THIRD DEVICE USED TO RETRIEVE OLD THROMBOTIC MATERIAL FROM THE ANASTOMOSIS, BUT IT ALSO RUPTURED AT THE SECOND PASSAGE. THE THROMBUS REMOVAL WAS INCOMPLETE. NO INJURY WAS REPORTED TO THE PATIENT. NOTE: THIS IS REPORT 3 OF 3 RELATED TO THE THIRD CATHETER USED IN THE EVENT. REPORTS 1220948-2024-00235 AND 1220948-2024-00236 WERE SUBMITTED FOR THE FIRST AND SECOND DEVICES INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20776987 ↗
• MalfunctionNov 11, 2024Material Separation; Failure to Deflate; Material Separation; Failure to Deflate

  THE PATIENT WAS ADMITTED TO HOSPITAL WITH A RUPTURED ABDOMINAL AORTIC ANEURYSM AND NEEDED AN EMERGENCY DOWNSTREAM EMBOLECTOMY. THE CATHETER WAS INSERTED INTO THE LEFT ILIAC, AND DESPITE TRYING TO DEFLATE THE BALLOON IT WOULDN'T DEFLATE AND HAD DIFFICULTY PULLING BACK AND WAS STUCK. THE TIP OF THE CATHETER SNAPPED INSIDE PATIENT AND WAS MISSING. AN X-RAY WAS PERFORMED ON THE PATIENT, BUT THEY WERE UNABLE LOCATE THE MISSING PART TO RETRIEVE IT. NO OTHER INJURY OR COMPLICATION WAS REPORTED. THE PATIENT WAS STILL IN THE ICU DUE TO THE EMERGENCY OPERATION FOR RUPTURED ABDOMINAL AORTIC ANEURYSM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20653720 ↗
• MalfunctionJul 24, 2024Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT THE BALLOON IS NOT DEFLATING AFTER INFLATION. THE ISSUE OCCURRED WITH THREE DEVICES. DURING THE PROCEDURE THE PATIENT EXPERIENCED BLEEDING, BUT THE CONDITION WAS STABILIZED AFTER THE PROCEDURE. NOTE: THIS IS REPORT 3 OF 3 RELATED TO THE THIRD CATHETER USED IN THE EVENT. REPORTS 1220948-2024-00123 AND 1220948-2024-00142 WERE SUBMITTED FOR THE FIRST AND SECOND DEVICES INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19819997 ↗
• MalfunctionJul 24, 2024Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT THE BALLOON IS NOT DEFLATING AFTER INFLATION. THE ISSUE OCCURRED WITH THREE DEVICES. DURING THE PROCEDURE THE PATIENT EXPERIENCED BLEEDING, BUT THE CONDITION WAS STABILIZED AFTER THE PROCEDURE. NOTE: THIS IS REPORT 1 OF 3 RELATED TO THE FIRST CATHETER USED IN THE EVENT. REPORTS 1220948-2024-00142 AND 1220948-2024-00143 WERE SUBMITTED FOR THE SECOND AND THIRD DEVICES INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19819985 ↗
• MalfunctionJul 24, 2024Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT THE BALLOON IS NOT DEFLATING AFTER INFLATION. THE ISSUE OCCURRED WITH THREE DEVICES. DURING THE PROCEDURE THE PATIENT EXPERIENCED BLEEDING, BUT THE CONDITION WAS STABILIZED AFTER THE PROCEDURE. NOTE: THIS IS REPORT 2 OF 3 RELATED TO THE SECOND CATHETER USED IN THE EVENT. REPORTS 1220948-2024-00123 AND 1220948-2024-00143 WERE SUBMITTED FOR THE FIRST AND THIRD DEVICES INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19819951 ↗
• MalfunctionFeb 9, 2024Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT THE BALLOON DID NOT DEFLATE. IT WAS NOT DETERMINED IF THE DEVICE WAS CHECKED PRIOR TO USE. NO INJURY WAS REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18677135 ↗
• MalfunctionJan 3, 2024Failure to Deflate; Failure to Deflate

  IT WAS REPORTED BY THE OPERATING ROOM NURSE THAT FOUR DEVICES FROM THE SAME LOT HAD AN ISSUE WITH THE BALLOON NOT DEFLATING. THE USER STATED NO PRE-USE CHECK WAS PERFORMED ON THE DEVICES. NO INJURY WAS REPORTED TO THE PATIENT. THIS IS REPORT 4 OF 4 RELATED TO THE FOURTH CATHETER USED IN THE EVENT. REPORT 1220948-2023-00210, 1220948-2023-00211, 1220948-2023-00212 WERE SUBMITTED FOR THE FIRST, SECOND, AND THIRD DEVICES INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18436296 ↗
• MalfunctionJan 3, 2024Failure to Deflate; Failure to Deflate

  IT WAS REPORTED BY THE OPERATING ROOM NURSE THAT FOUR DEVICES FROM THE SAME LOT HAD AN ISSUE WITH THE BALLOON NOT DEFLATING. THE USER STATED NO PRE-USE CHECK WAS PERFORMED ON THE DEVICES. NO INJURY WAS REPORTED TO THE PATIENT. THIS IS REPORT 3 OF 4 RELATED TO THE THIRD CATHETER USED IN THE EVENT. REPORT 1220948-2023-00210, 1220948-2023-00211, 1220948-2023-00213 WERE SUBMITTED FOR THE FIRST, SECOND, AND FOURTH DEVICES INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18436295 ↗
• MalfunctionJan 3, 2024Failure to Deflate; Failure to Deflate

  IT WAS REPORTED BY THE OPERATING ROOM NURSE THAT FOUR DEVICES FROM THE SAME LOT HAD AN ISSUE WITH THE BALLOON NOT DEFLATING. THE USER STATED NO PRE-USE CHECK WAS PERFORMED ON THE DEVICES. NO INJURY WAS REPORTED TO THE PATIENT. THIS IS REPORT 2 OF 4 RELATED TO THE SECOND CATHETER USED IN THE EVENT. REPORT 1220948-2023-00210, 1220948-2023-00212, 1220948-2023-00213 WERE SUBMITTED FOR THE FIRST, THIRD, AND FOURTH DEVICES INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18436278 ↗
• MalfunctionJan 3, 2024Failure to Deflate; Failure to Deflate

  IT WAS REPORTED BY THE OPERATING ROOM NURSE THAT FOUR DEVICES FROM THE SAME LOT HAD AN ISSUE WITH THE BALLOON NOT DEFLATING. THE USER STATED NO PRE-USE CHECK WAS PERFORMED ON THE DEVICES. NO INJURY WAS REPORTED TO THE PATIENT. THIS IS REPORT 1 OF 4 RELATED TO THE FIRST CATHETER USED IN THE EVENT. REPORT 1220948-2023-00211, 1220948-2023-00212, 1220948-2023-00213 WERE SUBMITTED FOR THE SECOND, THIRD, AND FOURTH DEVICES INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18436261 ↗
• MalfunctionFeb 16, 2023Material Rupture; Material Rupture

  A TUFTEX EMBOLECTOMY CATHETER WAS BEING USED FOR A PROCEDURE. THE FIRST CATHETER WAS INSERTED INTO THE BLOOD VESSEL AND THE BALLOON WAS INFLATED. THE BALLOON IMMEDIATELY RUPTURED. PLEASE NOTE THAT REPORT 1220948-2023-00016 WAS SUBMITTED RELATED TO THE FIRST DEVICE INVOLVED IN THIS INCIDENT. A SECOND DEVICE WAS USED TO CONTINUE TO PROCEDURE, HOWEVER THE BALLOON OF THE SECOND DEVICE ALSO RUPTURED. A THIRD DEVICE WAS USED TO COMPLETE THE OPERATION. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16390120 ↗
• MalfunctionFeb 16, 2023Material Rupture; Material Rupture

  A TUFTEX EMBOLECTOMY CATHETER WAS BEING USED FOR A PROCEDURE. THE CATHETER WAS INSERTED INTO THE BLOOD VESSEL AND THE BALLOON WAS INFLATED. THE BALLOON IMMEDIATELY RUPTURED. A SECOND DEVICE WAS USED TO CONTINUE TO PROCEDURE, HOWEVER THE BALLOON OF THE SECOND DEVICE ALSO RUPTURED. PLEASE NOTE THAT REPORT 1220948-2023-00017 WAS SUBMITTED RELATED TO THE SECOND DEVICE INVOLVED IN THIS INCIDENT. A THIRD DEVICE WAS USED TO COMPLETE THE OPERATION. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16388825 ↗
• MalfunctionFeb 11, 2022Failure to Deflate; Failure to Deflate

  THE BALLOON OF THE LEMAITRE EMBOLECTOMY CATHETER FAILED TO DEFLATE DURING THE PRE-USE CHECK. THE SURGEON DID NOT USE THE DEVICE FOR THE EMBOLECTOMY PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13518284 ↗
• MalfunctionJan 21, 2022Difficult to Insert; Difficult to Insert

  DURING EMBOLECTOMY, THE SURGEON INSERTED THE CATHETER INTO THE PATIENT'S BLOOD VESSEL AND PERFORMED THE PROCEDURE AS USUAL. HE HAD TO PULL THE CLOT WITH A HIGHER FORCE THAN USUAL. BECAUSE THERE WAS STILL A CLOT IN THE BLOOD VESSEL, THE SURGEON ATTEMPTED TO INSERT THE CATHETER BACK INTO THE VESSEL TO PERFORM THE PROCEDURE AGAIN. HOWEVER, THIS TIME, THE CATHETER COULD NOT ENTER THE VESSEL. THROUGH INSPECTION, HE FOUND THAT THE BODY OF THE CATHETER WAS DEFORMED AND HE HAD TO USE ANOTHER CATHETER TO REMOVE THE RESIDUAL CLOT. THERE WAS NO HARM TO THE PATIENT BECAUSE OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13314918 ↗
• InjuryFeb 28, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING THROMBECTOMY IN SUPERFICIAL FEMORAL ARTERY, CATHETER TIP DISLODGED FROM THE CATHETER SHAFT DURING REMOVAL OF RESIDUAL THROMBI FROM THE PATIENT'S VESSEL. THE MALFUNCTION OCCURRED DURING SECOND PASS. SURGEON WAS ABLE TO REMOVE THE CATHETER TIP FROM THE PATIENT'S VESSEL. THE MALFUNCTION EXTENDED OPERATING TIME PERIOD BUT DID NOT RESULT IN ANY PATIENT INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 9770750 ↗
• MalfunctionDec 6, 2019Burst Container or Vessel; Burst Container or Vessel

  DURING THROMBECTOMY OF A POPLITEAL ARTERY USING A LEMAITRE 4F SINGLE LUMEN EMBOLECTOMY CATHETER, SURGEON INSERTED THE CATHETER SHAFT INTO THE PATIENT'S ARTERY. WHEN THE BALLOON WAS INFLATED AT ITS TARGET LOCATION, IT IMMEDIATELY RUPTURED. THERE WAS NO INJURY TO THE PATIENT AS THE RESULT OF THIS INCIDENT. SURGEON COMPLETED THE PROCEDURE USING A 3F SINGLE LUMEN CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9433146 ↗
• MalfunctionDec 4, 2019Deflation Problem; Deflation Problem

  DURING AN EMBOLECTOMY PROCEDURE, SURGEON INFLATED A 4F LEMAITRE EMBOLECTOMY CATHETER AND INSERTED INTO THE ARTERY OF THE LOWER LIMB. SURGEON WAS ABLE TO PARTIALLY REMOVE THE CLOT FROM THE ARTERY. HOWEVER, HE OBSERVED A SECTION OF THE BALLOON BEYOND THE DISTAL LIGATURE REMAINED INFLATED DESPITE THE REMAINING SECTION OF THE BALLOON HAD DEFLATED PROPERLY. THIS IS REPORT 1 OF 2 OF THIS SERIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9413613 ↗
• MalfunctionDec 4, 2019Deflation Problem; Deflation Problem

  DURING AN EMBOLECTOMY PROCEDURE, SURGEON INFLATED A 4F LEMAITRE EMBOLECTOMY CATHETER AND INSERTED INTO THE ARTERY OF THE LOWER LIMB. SURGEON WAS ABLE TO PARTIALLY REMOVE THE CLOT FROM THE ARTERY. HOWEVER, HE OBSERVED A SECTION OF THE BALLOON BEYOND THE DISTAL LIGATURE REMAINED INFLATED DESPITE THE REMAINING SECTION OF THE BALLOON HAD DEFLATED PROPERLY. THIS IS REPORT 2 OF 2 OF THIS SERIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9413607 ↗
• MalfunctionAug 17, 2018Deflation Problem; Deflation Problem

  DURING PRE-USE CHECK, SURGEON INFLATED THE BALLOON OF A SINGLE LUMEN CATHETER USING SALINE. UPON INFLATION, HE OBSERVED THAT A SECTION OF THE BALLOON BEYOND DISTAL LIGATURE ALSO INFLATED. HOWEVER, THIS SECTION OF THE BALLOON FAILED TO DEFLATE WHEN HE PULLED THE PLUNGER OF THE SYRINGE ALTHOUGH THE SECTION OF BALLOON BELOW THE DISTAL LIGATURE DEFLATED PROPERLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7794413 ↗
• MalfunctionAug 16, 2018Inflation Problem; Inflation Problem

  DURING PRE-USE CHECK, THE PHYSICIAN INJECTED 0.75 ML OF SALINE TO INFLATE THE BALLOON. HOWEVER, THE BALLOON DID NOT INFLATE SYMMETRICALLY.

  Patient problems: No Information

  MAUDE report 7790812 ↗
• MalfunctionJul 25, 2018Deflation Problem; Deflation Problem

  A SECTION OF THE BALLOON BEYOND THE DISTAL LIGATURE REMAINED INFLATED DESPITE THE REMAINING PART OF THE BALLOON DEFLATING PROPERLY.

  Patient problems: No Information

  MAUDE report 7720137 ↗
• MalfunctionNov 28, 2017Detachment Of Device Component; Detachment Of Device Component

  THE BALLOON CAME OFF DURING THE PROCEDURE. THEY WERE ABLE TO RETRIEVE THE BALLOON.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7064815 ↗

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-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-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-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-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-0557-05 · Feb 7, 2005 · Terminated
  LeMaitre Embolectomy Catheter 2F Single Lumen, Balloon Volume 0.05 ml, Length 60 cm. Latex Model: 1601-26
• 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