Syntel Silicone OTW Embolectomy Catheter A4E08Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00840663109937), received between May 10, 2023 and Apr 7, 2026 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (15 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 7, 2026Material Rupture

  IT WAS REPORTED THAT DURING A VAIVT PROCEDURE, THE BALLOON RUPTURED UPON INFLATION AT THE TARGET SITE. A REPLACEMENT CATHETER OF THE SAME TYPE WAS THEN USED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24798672 ↗
• MalfunctionMar 17, 2026Material Rupture

  IT WAS REPORTED THAT DURING A VAIVT PROCEDURE, THE BALLOON RUPTURED WHEN IT WAS INFLATED AT THE TARGET SITE. ANOTHER CATHETER OF THE SAME TYPE WAS USED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24618217 ↗
• MalfunctionJan 12, 2026Material Rupture

  IT WAS REPORTED THAT DURING A VAIVT PROCEDURE, THE BALLOON RUPTURED UPON INFLATION AT THE TARGET SITE. A REPLACEMENT DEVICE WAS USED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT INJURY WAS REPORTED. NOTE: THIS IS REPORT 2 OF 2 RELATED TO THE SECOND CATHETER USED IN THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24044911 ↗
• MalfunctionJan 12, 2026Material Rupture

  IT WAS REPORTED THAT DURING A VAIVT PROCEDURE, THE BALLOON RUPTURED UPON INFLATION AT THE TARGET SITE. A REPLACEMENT DEVICE WAS USED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT INJURY WAS REPORTED. NOTE: THIS IS REPORT 1 OF 2 RELATED TO THE FIRST CATHETER USED IN THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24044735 ↗
• MalfunctionDec 2, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT PRIOR TO PATIENT USE, A PRE-USE INSPECTION WAS PERFORMED. THE PHYSICIAN INFLATED THE BALLOON AND INJECTED NORMAL SALINE INTO THE GUIDEWIRE LUMEN, DETERMINING THE PRODUCT TO BE ACCEPTABLE BEFORE PROCEEDING WITH THE THROMBECTOMY. THE CATHETER TIP SUCCESSFULLY PASSED THROUGH THE STENOTIC LESION, AND THE BALLOON WAS INFLATED WITH THE SPECIFIED AMOUNT OF NORMAL SALINE. HOWEVER, DURING WITHDRAWAL OF THE CATHETER, THE PHYSICIAN NOTICED AN UNEXPECTED LACK OF RESISTANCE. SUBSEQUENT EXTERNAL INSPECTION, PERFORMED BY ATTEMPTING TO INFLATE THE BALLOON OUTSIDE THE BODY, CONFIRMED THAT THE BALLOON HAD RUPTURED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A SPARE UNIT OF THE SAME PRODUCT AVAILABLE AT THE CLINIC, WITH NO FURTHER ISSUES. NO HARM TO THE PATIENT'S HEALTH WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23701074 ↗
• MalfunctionNov 24, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING A VAIVT PROCEDURE, THE BALLOON RUPTURED DURING EXPANSION AT THE TARGET SITE. A NEW DEVICE OF THE SAME PRODUCT WAS USED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23640519 ↗
• MalfunctionJul 25, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT AFTER OPENING THE PACKAGING, THE PHYSICIAN CONDUCTED A PRE-USE INSPECTION BEFORE APPLYING THE DEVICE TO THE PATIENT. THIS INCLUDED BALLOON INFLATION AND THE INJECTION OF SALINE INTO THE GUIDEWIRE LUMEN. NO ISSUES WERE IDENTIFIED AT THAT TIME, SO HE PROCEEDED WITH THE THROMBECTOMY. AFTER PASSING THROUGH THE STENOTIC AREA AND INFLATING THE BALLOON TO THE SPECIFIED VOLUME, HE ATTEMPTED TO WITHDRAW THE CATHETER. HOWEVER, HE NOTICED AN UNUSUAL LACK OF RESISTANCE. WHEN HE TESTED BALLOON INFLATION OUTSIDE THE BODY, HE FOUND THAT THE BALLOON HAD RUPTURED. NO INJURY WAS REPORTED TO THE PATIENT. NOTE: THIS IS REPORT 3 OF 3 RELATED TO THE THIRD CATHETER USED IN THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22606395 ↗
• MalfunctionJul 25, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT AFTER OPENING THE PACKAGING, THE PHYSICIAN CONDUCTED A PRE-USE INSPECTION BEFORE APPLYING THE DEVICE TO THE PATIENT. THIS INCLUDED BALLOON INFLATION AND THE INJECTION OF SALINE INTO THE GUIDEWIRE LUMEN. NO ISSUES WERE IDENTIFIED AT THAT TIME, SO HE PROCEEDED WITH THE THROMBECTOMY. AFTER PASSING THROUGH THE STENOTIC AREA AND INFLATING THE BALLOON TO THE SPECIFIED VOLUME, HE ATTEMPTED TO WITHDRAW THE CATHETER. HOWEVER, HE NOTICED AN UNUSUAL LACK OF RESISTANCE. WHEN HE TESTED BALLOON INFLATION OUTSIDE THE BODY, HE FOUND THAT THE BALLOON HAD RUPTURED. NO INJURY WAS REPORTED TO THE PATIENT. NOTE: THIS IS REPORT 2 OF 3 RELATED TO THE SECOND CATHETER USED IN THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22604801 ↗
• MalfunctionJul 24, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT AFTER OPENING THE PACKAGING, THE PHYSICIAN CONDUCTED A PRE-USE INSPECTION BEFORE APPLYING THE DEVICE TO THE PATIENT. THIS INCLUDED BALLOON INFLATION AND THE INJECTION OF SALINE INTO THE GUIDEWIRE LUMEN. NO ISSUES WERE IDENTIFIED AT THAT TIME, SO HE PROCEEDED WITH THE THROMBECTOMY. AFTER PASSING THROUGH THE STENOTIC AREA AND INFLATING THE BALLOON TO THE SPECIFIED VOLUME, HE ATTEMPTED TO WITHDRAW THE CATHETER. HOWEVER, HE NOTICED AN UNUSUAL LACK OF RESISTANCE. WHEN HE TESTED BALLOON INFLATION OUTSIDE THE BODY, HE FOUND THAT THE BALLOON HAD RUPTURED. NO INJURY WAS REPORTED TO THE PATIENT. NOTE: THIS IS REPORT 1 OF 3 RELATED TO THE FIRST CATHETER USED IN THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22602988 ↗
• MalfunctionJan 8, 2025Material Rupture; Material Rupture

  THE CATHETER WAS USED TO REMOVE BLOOD CLOTS NEAR THE SHUNT AREA. WHEN THE BALLOON WAS INFLATED IN THE VESSEL, IT RUPTURED. ANOTHER CATHETER WAS QUICKLY PREPARED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING IT. NO INJURY WAS REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21102608 ↗
• MalfunctionNov 5, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED WHEN IT WAS INFLATED IN THE VESSEL. THE CATHETER WAS USED TO REMOVE BLOOD CLOTS NEAR THE SHUNT AREA. ANOTHER CATHETER WAS USED TO THE SUCCESSFULLY COMPLETE THE OPERATION. NO INJURY WAS REPORTED TO THE PATIENT. NOTE: THIS IS REPORT 2 OF 2 RELATED TO THE SECOND CATHETER USED IN THE EVENT. REPORT 1220948-2024-00215 WAS SUBMITTED FOR THE FIRST DEVICE INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20608817 ↗
• MalfunctionNov 5, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED WHEN IT WAS INFLATED IN THE VESSEL. THE CATHETER WAS USED TO REMOVE BLOOD CLOTS NEAR THE SHUNT AREA. ANOTHER CATHETER WAS USED TO THE SUCCESSFULLY COMPLETE THE OPERATION. NO INJURY WAS REPORTED TO THE PATIENT. NOTE: THIS IS REPORT 1 OF 2 RELATED TO THE FIRST CATHETER USED IN THE EVENT. REPORT 1220948-2024-00216 WAS SUBMITTED FOR THE SECOND DEVICE INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20608805 ↗
• MalfunctionNov 1, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON RUPTURED DURING INFLATION TO REMOVE A BLOOD CLOT FOR AN EMBOLECTOMY PROCEDURE. THE SALINE VOLUME DID NOT EXCEED THE RECOMMENDED VOLUME. IT APPEARS THE CATHETER WAS USED AT THE STENOTIC REGIONS. NO FRAGMENT WAS LEFT INSIDE THE PATIENT. THE DEVICE WAS CHECKED PRIOR TO USE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER DEVICE. NO INJURY WAS REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20587607 ↗
• MalfunctionNov 2, 2023Material Rupture; Material Rupture

  THIS CATHETER WAS USED TO REMOVE A BLOOD CLOTS NEAR THE SHUNT AREA. THE BALLOON WAS RUPTURED WHILE COLLECTING A BLOOD CLOTS FROM THE TARGET LESION. THE OPERATION WAS SUCCESSFULLY COMPLETED USING ANOTHER CATHETER. NO INJURY WAS REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18058023 ↗
• MalfunctionMay 10, 2023Material Rupture; Material Rupture

  THE BALLOON RUPTURED WHILE REMOVING THE CLOT. THERE WERE NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16903142 ↗

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