LeMaitre Embolectomy Catheter e1801-48Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00840663101047), received between Aug 9, 2019 and May 12, 2025 — classified as 5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE SYNTEL SILICONE EMBOLECTOMY CATHETER BALLOON RUPTURED WHILE ATTEMPTING TO REMOVE A CLOT DURING A PROCEDURE. NO INJURY WAS REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22001370 ↗
• MalfunctionAug 11, 2023Material Rupture; Material Rupture

  IT WAS REPORTED SYNTEL SILICONE EMBOLECTOMY CATHETER - REGULAR TIP BALLOON RUPTURED IN VESSEL DURING BYPASS PROCEDURE. NO INJURY REPORTED TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17508195 ↗
• MalfunctionJul 7, 2023Difficult to Remove; Failure to Deflate; Difficult to Remove; Failure to Deflate

  IT WAS REPORTED SYNTEL SILICONE EMBOLECTOMY CATHETER - REGULAR TIP BALLOON NOT DEFLATING AND STUCK IN PATIENT DURING DE-CLOT ACCESS CENTER PROCEDURE. THE BALLOON HAD TO BE PHYSICALLY POPPED WITH A NEEDLE. NO INJURY OCCURRED TO PATIENT. IT WAS ALSO STATED CUSTOMER HAS BEEN HAVING A LOT OF BALLOON RUPTURE DURING USE WITH PATIENT, BUT NO FURTHER INFORMATION (DATE AND LOT NUMBERS) WERE AVAILABLE. THE DEVICE WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17277731 ↗
• 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 2 OF 3 AND DESCRIBES A SILICONE BASED BALLOON FAILURE. REPORT 1 OF 3 DESCRIBES ANOTHER SILICONE BASED BALLOON FAILURE AND 3 OF 3 DESCRIBES A LATEX BASED BALLOON FAILURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8880775 ↗
• 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 1 OF 3 AND DESCRIBES A SILICONE BASED BALLOON FAILURE. REPORT 2 OF 3 DESCRIBES ANOTHER SILICONE BASED BALLOON FAILURE AND 3 OF 3 DESCRIBES A LATEX BASED BALLOON FAILURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8880772 ↗

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-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-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-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-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-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