LeMaitre Embolectomy Catheter 1801-48Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00840663100927), received between Sep 14, 2018 and Sep 24, 2024 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (10 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT FOUR SYNTEL SILICONE EMBOLECTOMY CATHETER - REGULAR TIP BALLOON RUPTURED DURING USE. NO INJURY WAS REPORTED TO THE PATIENTS. MORE INFORMATION IN REGARDS TO THE REPORTED INCIDENTS WERE REQUESTED. NOTE: THIS IS REPORT 4 OF 4 RELATED TO THE FOURTH CATHETER USED IN THE EVENT. REPORTS 1220948-2024-00187, 1220948-2024-00188, AND 1220948-2024-00189 WERE SUBMITTED FOR THE FIRST, SECOND, AND THIRD DEVICES INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20295368 ↗
• MalfunctionJan 24, 2024Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT IT TOOK A CONSIDERABLE AMOUNT OF TIME TO DEFLATE THE BALLOON. ALSO, IT SEEMS THAT THE BALLOON OF THIS PRODUCT INFLATED ASYMMETRICALLY. THEREFORE, THE PHYSICIAN DISCONTINUED USING THE DEVICE. A REPLACEMENT DEVICE WITH THE SAME LOT NUMBER WAS USED TO COMPLETE THE OPERATION. NO INJURY WAS REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18575632 ↗
• MalfunctionOct 3, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THE SYNTEL SILICONE EMBOLECTOMY CATHETER BALLOON RUPTURED DURING A PROCEDURE. THE BALLOON WAS NOT OVER INFLATED, BUT RATHER UNDER INFLATED. THERE WERE NO CALCIUM BUILD UP IN THE PATIENT'S VESSEL. THE SURGEONS WERE CONVINCED IT WAS A PRODUCT MANUFACTURING ISSUE WITH NO ERROR IN USAGE OR PATIENT CONDITION. A 12TLW804F FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER MANUFACTURED BY BAXTER WAS USED TO COMPLETE THE PROCEDURE. NO INJURY WAS REPORTED TO THE PATIENT. NOTE: THIS IS REPORT 8 OF 9 RELATED TO THE EIGHTH CATHETER USED IN THE EVENT. REPORT 1220948-2023-00160, 1220948-2023-00161, 1220948-2023-00162, 1220948-2023-00163, 1220948-2023-00164, 1220948-2023-00165, 1220948-2023-00166, 1220948-2023-00168 WAS SUBMITTED FOR THE FIRST, SECOND, THIRD, FOURTH, FIFTH, SIXTH, SEVENTH, AND NINTH DEVICES INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17862320 ↗
• MalfunctionOct 3, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THE SYNTEL SILICONE EMBOLECTOMY CATHETER BALLOON RUPTURED DURING A PROCEDURE. THE BALLOON WAS NOT OVER INFLATED, BUT RATHER UNDER INFLATED. THERE WERE NO CALCIUM BUILD UP IN THE PATIENT'S VESSEL. THE SURGEONS WERE CONVINCED IT WAS A PRODUCT MANUFACTURING ISSUE WITH NO ERROR IN USAGE OR PATIENT CONDITION. A 12TLW804F FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER MANUFACTURED BY BAXTER WAS USED TO COMPLETE THE PROCEDURE. NO INJURY WAS REPORTED TO THE PATIENT. NOTE: THIS IS REPORT 7 OF 9 RELATED TO THE SEVENTH CATHETER USED IN THE EVENT. REPORT 1220948-2023-00160, 1220948-2023-00161, 1220948-2023-00162, 1220948-2023-00163, 1220948-2023-00164, 1220948-2023-00165, 1220948-2023-00167, 1220948-2023-00168 WAS SUBMITTED FOR THE FIRST, SECOND, THIRD, FOURTH, FIFTH, SIXTH, EIGHTH, AND NINTH DEVICES INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17862292 ↗
• MalfunctionOct 3, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THE SYNTEL SILICONE EMBOLECTOMY CATHETER BALLOON RUPTURED DURING A PROCEDURE. THE BALLOON WAS NOT OVER INFLATED, BUT RATHER UNDER INFLATED. THERE WERE NO CALCIUM BUILD UP IN THE PATIENT'S VESSEL. A 12TLW804F FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER MANUFACTURED BY BAXTER WAS USED TO COMPLETE THE PROCEDURE. NO INJURY WAS REPORTED TO THE PATIENT. NOTE: THIS IS REPORT 6 OF 9 RELATED TO THE SIXTH CATHETER USED IN THE EVENT. REPORT 1220948-2023-00160, 1220948-2023-00161, 1220948-2023-00162, 1220948-2023-00163, 1220948-2023-00164, 1220948-2023-00166, 1220948-2023-00167, 1220948-2023-00168 WAS SUBMITTED FOR THE FIRST, SECOND, THIRD, FOURTH, FIFTH, SEVENTH, EIGHTH, AND NINTH DEVICES INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17862277 ↗
• MalfunctionOct 3, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THE SYNTEL SILICONE EMBOLECTOMY CATHETER BALLOON RUPTURED DURING A PROCEDURE. THE BALLOON WAS NOT OVER INFLATED, BUT RATHER UNDER INFLATED. THERE WERE NO CALCIUM BUILD UP IN THE PATIENT'S VESSEL. A 12TLW804F FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER MANUFACTURED BY BAXTER WAS USED TO COMPLETE THE PROCEDURE. NO INJURY WAS REPORTED TO THE PATIENT. NOTE: THIS IS REPORT 5 OF 9 RELATED TO THE FIFTH CATHETER USED IN THE EVENT. REPORT 1220948-2023-00160, 1220948-2023-00161, 1220948-2023-00162, 1220948-2023-00163, 1220948-2023-00165, 1220948-2023-00166, 1220948-2023-00167, 1220948-2023-00168 WAS SUBMITTED FOR THE FIRST, SECOND, THIRD, FOURTH, SIXTH, SEVENTH, EIGHTH, AND NINTH DEVICES INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17862276 ↗
• MalfunctionOct 3, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THE SYNTEL SILICONE EMBOLECTOMY CATHETER BALLOON RUPTURED DURING A PROCEDURE. THE BALLOON WAS NOT OVER INFLATED, BUT RATHER UNDER INFLATED. THERE WERE NO CALCIUM BUILD UP IN THE PATIENT'S VESSEL. A 12TLW804F FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER MANUFACTURED BY BAXTER WAS USED TO COMPLETE THE PROCEDURE. NO INJURY WAS REPORTED TO THE PATIENT. NOTE: THIS IS REPORT 4 OF 9 RELATED TO THE FOURTH CATHETER USED IN THE EVENT. REPORT 1220948-2023-00160, 1220948-2023-00161, 1220948-2023-00162, 1220948-2023-00164, 1220948-2023-00165, 1220948-2023-00166, 1220948-2023-00167, 1220948-2023-00168 WAS SUBMITTED FOR THE FIRST, SECOND, THIRD, FIFTH, SIXTH, SEVENTH, EIGHTH, AND NINTH DEVICES INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17862268 ↗
• MalfunctionOct 3, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THE SYNTEL SILICONE EMBOLECTOMY CATHETER BALLOON RUPTURED DURING A PROCEDURE. THE BALLOON WAS NOT OVER INFLATED, BUT RATHER UNDER INFLATED. THERE WERE NO CALCIUM BUILD UP IN THE PATIENT'S VESSEL. A 12TLW804F FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER MANUFACTURED BY BAXTER WAS USED TO COMPLETE THE PROCEDURE. NO INJURY WAS REPORTED TO THE PATIENT. NOTE: THIS IS REPORT 3 OF 9 RELATED TO THE THIRD CATHETER USED IN THE EVENT. REPORT 1220948-2023-00160, 1220948-2023-00161, 1220948-2023-00163, 1220948-2023-00164, 1220948-2023-00165, 1220948-2023-00166, 1220948-2023-00167, 1220948-2023-00168 WAS SUBMITTED FOR THE FIRST, SECOND, FOURTH, FIFTH, SIXTH, SEVENTH, EIGHTH, AND NINTH DEVICES INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17862267 ↗
• MalfunctionOct 3, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THE SYNTEL SILICONE EMBOLECTOMY CATHETER BALLOON RUPTURED DURING A PROCEDURE. THE BALLOON WAS NOT OVER INFLATED, BUT RATHER UNDER INFLATED. THERE WERE NO CALCIUM BUILD UP IN THE PATIENT'S VESSEL. A 12TLW804F FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER MANUFACTURED BY BAXTER WAS USED TO COMPLETE THE PROCEDURE. NO INJURY WAS REPORTED TO THE PATIENT. NOTE: THIS IS REPORT 2 OF 9 RELATED TO THE SECOND CATHETER USED IN THE EVENT. REPORT 1220948-2023-00160, 1220948-2023-00162, 1220948-2023-00163, 1220948-2023-00164, 1220948-2023-00165, 1220948-2023-00166, 1220948-2023-00167, 1220948-2023-00168 WAS SUBMITTED FOR THE FIRST, THIRD, FOURTH, FIFTH, SIXTH, SEVENTH, EIGHTH, AND NINTH DEVICES INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17862261 ↗
• MalfunctionJun 27, 2019Material Rupture; Material Rupture

  THE SURGEON REPORTED THAT DURING PRE-USE CHECK, THE BALLOON OF THE LEMAITRE NOVASIL SINGLE LUMEN EMBOLECTOMY CATHETER BURST AFTER INFLATING THE BALLOON WITH 0.6 CC OF SALINE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8740232 ↗
• MalfunctionJun 3, 2019Material Rupture; Material Rupture

  THE SURGEON REPORTED THAT THE BALLOONS OF THE LEMAITRE NOVASIL SINGLE LUMEN EMBOLECTOMY CATHETERS BURST DURING EMBOLECTOMY PROCEDURE WHEN THE BALLOONS WERE EXPOSED TO HIGHLY CALCIFIED VESSEL. THIS IS REPORT 3 OF 3 OF THAT SERIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8664932 ↗
• MalfunctionSep 14, 2018Unraveled Material; Unraveled Material

  THE PROXIMAL LIGATURE WAS FOUND TO HAVE PARTIALLY UNWOUND DURING THROMBECTOMY PROCEDURE IN TWO OF THE NOVASIL EMBOLECTOMY CATHETERS.

  Patient problems: No Information

  MAUDE report 7877813 ↗

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-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-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-0558-05 · Feb 7, 2005 · Terminated
  LeMaitre Embolectomy Catheter 3F Single Lumen, Balloon volume 0.2ml, Length 80 cm, Latex Model: 1601-38
• 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-0560-05 · Feb 7, 2005 · Terminated
  LeMaitre Embolectomy Catheter 5F Single Lumen, Balloon Volume 1.5 ml, Length 80 cm, Latex Model: 1601-58