LeMaitre Embolectomy Catheter 1801-38Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00840663100903), received between Jun 3, 2019 and Jan 17, 2025 — classified as 4 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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 17, 2025Material Rupture; Material Rupture

  IT WAS REPORTED WHILE THE DEVICE WAS BEING PREPARED BY REMOVING THE AIR, THE BALLOON RUPTURED. ANOTHER DEVICE WAS OPENED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO INJURY WAS REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21179198 ↗
• 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 9 OF 9 RELATED TO THE NINTH 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, 1220948-2023-00167 WAS SUBMITTED FOR THE FIRST, SECOND, THIRD, FOURTH, FIFTH, SIXTH, SEVENTH, AND EIGHTH DEVICES INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17862300 ↗
• 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 1 OF 9 RELATED TO THE FIRST CATHETER USED IN THE EVENT. REPORT 1220948-2023-00161, 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 SECOND, THIRD, FOURTH, FIFTH, SIXTH, SEVENTH, EIGHTH, AND NINTH DEVICES INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17862258 ↗
• 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 2 OF 3 OF THAT SERIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8664930 ↗

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-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-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-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-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