LeMaitre Embolectomy Catheter 1601-44Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00840663100484), received between Nov 8, 2017 and Apr 28, 2026 — classified as 1 injury, 21 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (8 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2026Material Rupture

  IT WAS REPORTED THAT DURING AN EMBOLECTOMY PROCEDURE, THE TUFTEX EMBOLECTOMY CATHETER BALLOON RUPTURED WHILE REMOVING A CLOT. THE DEVICE WAS CHECKED PRIOR TO USE AND THE BALLOON INFLATION WAS CONFIRMED TO BE ACCEPTABLE WITH NO LEAKAGE OBSERVED. THE SALINE VOLUME USED FOR BALLOON INFLATION DID NOT EXCEED THE RECOMMENDED LIMIT. THERE WAS NO INDICATION OF ABNORMAL STORAGE CONDITIONS FOR THE PRODUCT. THE DEVICE WAS REPORTEDLY USED IN A STENOTIC REGION. NO ADDITIONAL INCISION WAS MADE, AND NO SHARP OBJECT WAS USED TO PUNCTURE THE BALLOON. NO CATHETER FRAGMENTS WERE RETAINED IN THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A REPLACEMENT DEVICE. NO PATIENT INJURY OR ADVERSE IMPACT TO THE PATIENT'S HEALTH WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25016682 ↗
• MalfunctionApr 28, 2026Material Rupture

  IT WAS REPORTED THAT DURING AN EMBOLECTOMY PROCEDURE, THE TUFTEX EMBOLECTOMY CATHETER BALLOON RUPTURED WHILE REMOVING A CLOT. THE DEVICE HAD BEEN CHECKED PRIOR TO USE AND WAS CONFIRMED TO BE ACCEPTABLE, WITH SUCCESSFUL INFLATION AND NO LEAKAGE OBSERVED. THE SALINE VOLUME USED FOR BALLOON INFLATION DID NOT EXCEED THE RECOMMENDED LIMIT. THERE WAS NO INDICATION OF ABNORMAL STORAGE CONDITIONS. THE DEVICE WAS REPORTEDLY USED IN A STENOTIC REGION. NO ADDITIONAL INCISION WAS MADE, AND NO SHARP OBJECT WAS USED ON THE BALLOON. NO CATHETER FRAGMENTS WERE RETAINED IN THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A REPLACEMENT DEVICE. NO PATIENT INJURY OR ADVERSE IMPACT TO THE PATIENT'S HEALTH WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25016662 ↗
• MalfunctionApr 21, 2026Material Rupture

  IT WAS REPORTED THAT THE TUFTEX EMBOLECTOMY CATHETER BALLOON RUPTURED DURING A PROCEDURE. THE DEVICE WAS CHECKED PRIOR TO USE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24940188 ↗
• MalfunctionSep 26, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE TUFTEX EMBOLECTOMY CATHETER BALLOON RUPTURED DURING PRE-TEST. IT WAS IN DIRECT CONTACT WITH THE PATIENT. NO INJURY WAS REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20311290 ↗
• MalfunctionNov 9, 2023Material Rupture; Material Rupture

  IT WAS REPORTED A PRUITT F3 CAROTID SHUNT WAS LEAKING WHEN TRYING TO INFLATE THE BALLOONS DURING PRE-USE CHECK. NO INJURY WAS REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18101882 ↗
• MalfunctionMay 24, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THE BALLOON RUPTURED AS SOON AS THE THROMBECTOMY PROCEDURE STARTED. THERE WERE NO INJURY REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16991894 ↗
• MalfunctionApr 7, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE TUFTEX EMBOLECTOMY CATHETER WAS INSERTED INTO THE BLOOD VESSEL. WHILE THE PHYSICIAN WAS PULLING BACK THE CATHETER FOR THE EMBOLECTOMY HE WAS NO LONGER ABLE TO FEEL RESISTANCE. UPON CHECKING THE BALLOON IT WAS OBSERVED TO BE RUPTURED. THERE WAS NO CALCIFICATION OR SEVERE STENOSIS AT THE LESION. THE OPERATION WAS COMPLETED USING A REPLACEMENT DEVICE. NO INJURY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16702965 ↗
• MalfunctionFeb 3, 2023Material Rupture; Material Rupture

  IT WAS INITIALLY REPORTED THAT WHEN USING THE TUFTEX EMBOLECTOMY CATHETER THE BALLOON OF THE CATHETER WAS UNABLE TO INFLATE. HOWEVER, THE DEVICE INVESTIGATION WAS PERFORMED ON 05JAN2023, AND IT WAS DETERMINED THAT THE BALLOON OF THE DEVICE WAS RUPTURED. BASED ON THE INVESTIGATION FINDINGS, THIS INCIDENT WAS UPDATED TO A REPORTABLE INCIDENT WITH AWARENESS DATE OF 05JAN2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16293324 ↗
• MalfunctionOct 14, 2022Unintended Movement; Failure to Deflate; Unintended Movement; Failure to Deflate

  IT WAS REPORTED THAT DURING THE PRE-USE CHECK, THE BALLOON WAS NOT ABLE TO INFLATE, SO A DIFFERENT DEVICE WAS USED FOR THE OPERATION. HOWEVER, WHEN THE PRODUCT WAS RECEIVED IT WAS FOUND THAT THE RETURNED DEVICE HAD THE LIGATURE OF THE BALLOON SLIPPED TOWARD THE DISTAL END OF THE CATHETER, WHICH PREVENTED THE BALLOON FROM DEFLATING. THE BALLOON FAILING TO DEFLATE CAN POTENTIALLY CAUSE INJURY TO THE PATIENT OR REQUIRE THE SURGEON TO MANUALLY POP THE BALLOON TO PREVENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15606379 ↗
• MalfunctionJan 20, 2021Failure to Deflate; Failure to Deflate

  FOR EMBOLIZATION OF THE LEFT FEMORAL ARTERY, THE CATHETER SHAFT OF THIS PRODUCT WAS INSERTED INTO THE ARTERY. AND THE CLOT WAS REMOVED BY PULLING THE CATHETER WITH INFLATED BALLOON (THE FIRST THROMBECTOMY WAS COMPLETED SUCCESSFULLY). IN THE SAME WAY, THE SECOND THROMBECTOMY WAS PERFORMED WITH THIS PRODUCT AND COMPLETED SUCCESSFULLY. WHILE PERFORMING THE THIRD THROMBECTOMY WITH THIS PRODUCT, THE BALLOON BECAME UNABLE TO DEFLATE, SO THE CATHETER COULD NOT REMOVE FROM THE ARTERY. AS A RESULT, AFTER PERFORMING SURGICAL CUTDOWN NEAR THE BALLOON AND CUTTING THE CATHETER SHAFT, THE CATHETER SHAFT AND CATHETER TIP WAS SURGICALLY REMOVED. FINALLY, THE SURGICAL PROCEDURE WAS CHANGED FROM "THROMBECTOMY" TO "THROMBO-ENDARTERECTOMY (TAE)" AND THIS OPERATION WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11205132 ↗
• MalfunctionMay 23, 2019Unintended Movement; Unintended Movement

  DURING REMOVAL OF AN EMBOLI FROM AN ARTERIOVENOUS FISTULA, THE BALLOON OF THE SINGLE LUMEN EMBOLECTOMY CATHETER MALFUNCTIONED. UPON REMOVAL OF THE CATHETER FROM THE PATIENT'S VESSEL, SURGEON OBSERVED THAT THE LIGATURE ATTACHED ON BOTH ENDS OF THE BALLOON HAD SHIFTED. THERE WAS NO INJURY TO THE PATIENT AS THE RESULT OF THIS INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8636411 ↗
• MalfunctionJan 25, 2019Positioning Failure; Positioning Failure

  DURING PRE-USE CHECK, THE BALLOON OF THE CATHETER DID NOT INFLATE SYMMETRICALLY.

  Patient problems: No Information

  MAUDE report 8279469 ↗
• MalfunctionAug 23, 2018Deflation Problem; Deflation Problem

  THE BALLOON FAILED TO DEFLATE PROPERLY DURING EMBOLECTOMY PROCEDURE. THIS IS THE FOLLOW-UP REPORT OF THE MANUFACTURER'S REPORT# 1220948-2018-00060 THAT WAS INITIALLY SUBMITTED ON 8/23/2018.

  Patient problems: No Information

  MAUDE report 7809154 ↗
• MalfunctionJun 29, 2018Inflation Problem; Device Operational Issue; Inflation Problem; Device Operational Issue

  DURING EMBOLECTOMY PROCEDURE, AFTER LOCATING THE BALLOON OF THE SINGLE LUMEN CATHETER (CATALOG#: 1601-44; LOT#: SLC4417) PROXIMAL TO THE BLOOD CLOT, PHYSICIAN PULLED THE BALLOON TO REMOVE THE ADHERENT MATERIAL. HOWEVER, HE DID NOT FEEL ANY RESISTANCE WHILE DOING SO. WHEN HE PULLED THE CATHETER FROM THE VESSEL, HE OBSERVED THAT THE PROXIMAL LIGATURE OF THE BALLOON HAD LOOSENED AND THE BALLOON HAD DEFLATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7652951 ↗
• MalfunctionJun 27, 2018Deflation Problem; Deflation Problem

  DURING EMBOLECTOMY PROCEDURE, THE PHYSICIAN COULD NOT DEFLATE THE BALLOON COMPLETELY WHEN REMOVING THE CATHETER OUT OF THE PATIENT'S ARTERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7643236 ↗
• InjuryMar 28, 2018Burst Container or Vessel; Burst Container or Vessel

  BALLOON RUPTURED DURING AN EMBOLECTOMY PROCEDURE IN AN ILIAC ARTERY. SOME BALLOON FRAGMENTS REMAINED IN THE ILIAC ARTERY. SO, THE PHYSICIAN HAD TO USE ANOTHER EMBOLECTOMY CATHETER TO REMOVE THE FRAGMENTS.

  Patient problems: Foreign Body In Patient

  MAUDE report 7377705 ↗
• MalfunctionMar 21, 2018Device Slipped; Device Slipped

  THE BALLOON SEPARATED FROM THE CATHETER WHEN REMOVING A CLOT FROM THE CEPHALIC VEIN DURING AV FISTULA REVISION IN A DIALYSIS PATIENT. AS A RESULT, THE SURGEON REQUIRED ADDITIONAL CUT DOWN TO RETRIEVE THE SEPARATED BALLOON.

  Patient problems: Foreign Body In Patient

  MAUDE report 7357378 ↗
• MalfunctionFeb 2, 2018Deflation Problem; Deflation Problem

  SINGLE LUMEN CATHETER WAS USED IN RIGHT SFA. AFTER THE PROCEDURE, THE PHYSICIAN COULD NOT DEFLATE THE BALLOON WHEN REMOVING THE CATHETER OUT OF THE PATIENT'S ARTERY. THEREFORE, THE PHYSICIAN HAD TO LEAVE 3-4 CM OF THE TIP OF THE CATHETER INSIDE THE PATIENT'S ARTERY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7236008 ↗
• MalfunctionDec 5, 2017Deflation Problem; Deflation Problem

  THE LEMAITRE SINGLE LUMEN EMBOLECTOMY CATHETER WAS USED DURING AN EMERGENCY INTERVENTION. THE PHYSICIAN COULD NOT DEFLATE THE BALLOON COMPLETELY WHEN REMOVING THE BALLOON FROM THE PATIENT'S VESSEL.

  Patient problems: No Information

  MAUDE report 7084737 ↗
• MalfunctionNov 8, 2017Deflation Problem; Deflation Problem

  BALLOON COULD NOT BE DEFLATED.

  Patient problems: No Information

  MAUDE report 7010932 ↗
• MalfunctionNov 8, 2017Deflation Problem; Deflation Problem

  BALLOON COULD NOT BE DEFLATED.

  Patient problems: No Information

  MAUDE report 7010926 ↗
• MalfunctionNov 8, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING THROMBECTOMY FOR A DIALYSIS PATIENT, SINGLE LUMEN CATHETER WAS INSERTED INTO THE PATIENT'S BLOOD VESSEL. AFTER THE CATHETER REACHED ITS INTENDED LOCATION, THE BALLOON WAS INFLATED AND PULLED TO REMOVE THE THROMBI. WHILE PULLING THE CATHETER, IT ENCOUNTERED A STRICTURED SEGMENT INSIDE THE BLOOD VESSEL. WHEN HE TRIED TO PULL THE CATHETER, HE FELT A RESISTANCE WHILE DOING SO. HE COULD NOT PULL OR PUSH THE CATHETER ANY FURTHER. WHEN HE TRIED TO DEFLATE THE BALLOON, HE COULD NOT DO SO EITHER. SO, HE PULLED THE CATHETER WITH EXCESSIVE FORCE AND WAS ABLE TO REMOVE THE CATHETER FROM THE PATIENT'S VESSEL. HOWEVER, HE OBSERVED THE BALLOON ( 1 CM IN LENGTH ) WAS MISSING IN THE SHAFT OF THE CATHETER.

  Patient problems: Thrombus

  MAUDE report 7010922 ↗

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-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-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-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-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-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-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