LeMaitre Embolectomy Catheter e1801-44Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00840663101030), received between Dec 1, 2022 and Dec 18, 2025 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 18, 2025Material Rupture; Material Rupture

  DURING A THROMBECTOMY PROCEDURE FOR A DIALYSIS PATIENT (OPEN PROCEDURE WITHIN AN ARTIFICIAL GRAFT WITH NO NOTABLE CALCIFICATION), THE VESSEL WAS EXPOSED, THE CATHETER WAS PREPARED, AND INSERTED INTO THE VESSEL. UPON ATTEMPTED INFLATION, THE BALLOON WAS FOUND TO BE RUPTURED AND DID NOT INFLATE. USE OF THE DEVICE WAS DISCONTINUED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A NEW DEVICE OF THE SAME MODEL. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23839445 ↗
• MalfunctionSep 3, 2024Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT DURING THE PREUSE CHECK ONLY ONE SIDE OF THE BALLOON INFLATED. THEN WHEN ATTEMPTING TO DEFLATE, IT WOULD NOT DEFLATE. ANOTHER PRODUCT (SAME PRODUCT NUMBER) WAS USED TO COMPLETE THE OPERATION. NO INJURY WAS REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20127890 ↗
• MalfunctionDec 1, 2022Failure to Deflate; Failure to Deflate

  A CUSTOMER REPORTED VARIOUS ISSUES HAVE OCCURRED WHILE USING THE SYNTEL SILICONE EMBOLECTOMY CATHETER - REGULAR TIP DEVICES. IT WAS REPORTED THAT DURING USE, THE BALLOON OF THE CATHETER DID NOT DEFLATE. ADDITIONALLY, THE SITE REPORTED THREE ADDITIONAL INCIDENCES OF FAILURES WITH THIS PRODUCT. THE THREE ADDITIONAL DEVICES HAD BALLOONS RUPTURE DURING USE REQUIRING THE BALLOON TO MANUALLY BE REMOVED DURING THE OPERATION. NO INJURIES WERE REPORTED FOR THESE EVENTS. PLEASE NOTE THAT THIS IS REPORT 4 OF 4 RELATED TO THIS INCIDENT. REPORTS 1220948-2022-00124, 1220948-2022-00125 AND 1220948-2022-00126 WERE ALSO FILED IN RELATION TO THE INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15894207 ↗
• MalfunctionDec 1, 2022Material Rupture; Material Rupture

  A CUSTOMER REPORTED VARIOUS ISSUES HAVE OCCURRED WHILE USING THE SYNTEL SILICONE EMBOLECTOMY CATHETER - REGULAR TIP DEVICES. IT WAS REPORTED THAT THE USER HAD THE BALLOON OF THE CATHETER RUPTURE DURING USE AND THEY HAD TO RETRIEVE THE BROKEN PIECE WITH A SNARE. ADDITIONALLY, THE SITE REPORTED THREE ADDITIONAL INCIDENCES OF FAILURES WITH THIS PRODUCT. TWO ADDITIONAL DEVICES ALSO HAD BALLOONS RUPTURE DURING USE AND ONE DEVICE HAD THE BALLOON FAIL TO DEFLATE DURING USE. NO INJURIES WERE REPORTED FOR THESE EVENTS. PLEASE NOTE THAT THIS IS REPORT 2 OF 4 RELATED TO THIS INCIDENT. REPORTS 1220948-2022-00124, 1220948-2022-00126 AND 1220948-2022-00127 WERE ALSO FILED IN RELATION TO THE INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15894164 ↗
• MalfunctionDec 1, 2022Material Rupture; Material Rupture

  A CUSTOMER REPORTED VARIOUS ISSUES HAVE OCCURRED WHILE USING THE SYNTEL SILICONE EMBOLECTOMY CATHETER - REGULAR TIP DEVICES. IT WAS REPORTED THAT THE USER HAD THE BALLOON OF THE CATHETER RUPTURE DURING USE AND THEY HAD TO RETRIEVE THE BROKEN PIECE WITH A SNARE. ADDITIONALLY, THE SITE REPORTED THREE ADDITIONAL INCIDENCES OF FAILURES WITH THIS PRODUCT. TWO ADDITIONAL DEVICES ALSO HAD BALLOONS RUPTURE DURING USE AND ONE DEVICE HAD THE BALLOON FAIL TO DEFLATE DURING USE. NO INJURIES WERE REPORTED FOR THESE EVENTS. PLEASE NOTE THAT THIS IS REPORT 3 OF 4 RELATED TO THIS INCIDENT. REPORTS 1220948-2022-00124, 1220948-2022-00125 AND 1220948-2022-00127 WERE ALSO FILED IN RELATION TO THE INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15894161 ↗
• MalfunctionDec 1, 2022Material Rupture; Material Rupture

  A CUSTOMER REPORTED VARIOUS ISSUES HAVE OCCURRED WHILE USING THE SYNTEL SILICONE EMBOLECTOMY CATHETER - REGULAR TIP DEVICES. IT WAS REPORTED THAT THE USER HAD THE BALLOON OF THE CATHETER RUPTURE DURING USE AND THEY HAD TO RETRIEVE THE BROKEN PIECE WITH A SNARE. ADDITIONALLY, THE SITE REPORTED THREE ADDITIONAL INCIDENCES OF FAILURES WITH THIS PRODUCT. TWO ADDITIONAL DEVICES ALSO HAD BALLOONS RUPTURE DURING USE AND ONE DEVICE HAD THE BALLOON FAIL TO DEFLATE DURING USE. NO INJURIES WERE REPORTED FOR THESE EVENTS. PLEASE NOTE THAT THIS IS REPORT 1 OF 4 RELATED TO THIS INCIDENT. REPORTS 1220948-2022-00125, 1220948-2022-00126 AND 1220948-2022-00127 WERE ALSO FILED IN RELATION TO THE INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15894158 ↗

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