LeMaitre Embolectomy Catheter e1601-38Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840663100583), received between Aug 31, 2017 and Aug 9, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 9, 2019Material Rupture; Material Rupture

  THE SURGEON REPORTED THAT DURING THROMBECTOMY ON ONE PATIENT, THE BALLOONS OF THE THREE LEMAITRE EMBOCTOMY CATHETERS RUPTURED. TWO WERE SILICONE BASED BALLOONS AND ONE WAS A LATEX BALLOON. THIS IS REPORT 3 OF 3 AND DESCRIBES A LATEX BASED BALLOON FAILURE. REPORT 1 OF 3 DESCRIBES A SILICONE BASED BALLOON FAILURE AND 2 OF 3 DESCRIBES ANOTHER SILICONE BASED BALLOON FAILURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8880776 ↗
• MalfunctionAug 31, 2017Detachment Of Device Component; Material Rupture; Detachment Of Device Component; Material Rupture

  TIP OF THE CATHETER BROKE DURING USAGE.

  Patient problems: No Information

  MAUDE report 6836198 ↗

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-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-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-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-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-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