Syntel Silicone OTW Embolectomy Catheter A4E03Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00840663109883), received between Mar 19, 2025 and Aug 7, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (4 reports).

2 other recalls cover devices cleared under the same FDA submission (K970762); 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.

• MalfunctionAug 7, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED WHILE REMOVING A CLOT DURING AN EMBOLECTOMY PROCEDURE. THE OPERATION WAS COMPLETED SUCCESSFULLY USING A REPLACEMENT. DEVICE WAS PRE-CHECKED PRIOR TO USE. THE SALINE VOLUME DID NOT EXCEED THE RECOMMENDED VOLUME. CATHETER WAS USED AT THE STENOTIC REGIONS. NO INJURY WAS REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22738098 ↗
• MalfunctionJun 11, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED DURING CLINICAL USE. THE SURGERY WAS COMPLETED SUCCESSFULLY USING A REPLACEMENT PRODUCT. NO INJURY WAS REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22184271 ↗
• MalfunctionApr 25, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE SYNTEL OTW BALLOON RUPTURED DURING A THROMBECTOMY PROCEDURE AFTER BARELY BEING INFLATED. NO INJURY WAS REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21908368 ↗
• MalfunctionMar 19, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING A THROMBECTOMY IN A DIALYSIS PATIENT WITH THE VESSEL EXPOSED, THE CATHETER WAS PREPARED AND INSERTED INTO THE VESSEL. ATTEMPTS WERE MADE TO INFLATE THE BALLOON, BUT IT HAD RUPTURED AND WOULD NOT INFLATE. USE OF THE CATHETER WAS DISCONTINUED, AND A NEW DEVICE OF THE SAME TYPE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO INJURY WAS REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21641664 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K970762. One submission often covers many models, so check the product and lot details in each record.

• Z-1846-2020 · Oct 24, 2019 · Terminated
  Python Embolectomy Catheters, Sterile EO, CE, Ref numbers/UDI: A4E01/(01)00607915113407; A4E02/(01)00607915113414; A4E03/(01)00607915113421; A4E04/(01)00607915113438; A4E05/(01
• Z-1847-2020 · Oct 24, 2019 · Terminated
  Bard Embolectomy Catheter & 1 ml SYRINGE, REF numbers/UDI: CE0340DR/(01)H699CE0340DR10R; CE0380DR/(01)H699CE0380DR10V; CE0440DR/(01)H699CE0440DR10S; CE0480DR/(01)H699CE0480DR10