Syntel Silicone OTW Embolectomy Catheter A4E01Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00840663109869), received between Jun 2, 2022 and Oct 31, 2022 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (8 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 31, 2022Material Rupture; Material Rupture

  THE BALLOON OF THE SYNTEL OVER-THE-WIRE EMBOLECTOMY CATHETER RUPTURED DURING AN EMBOLECTOMY PROCEDURE. SO, THE SURGEON USED ANOTHER CATHETER FOR THE PROCEDURE. THERE WAS NO HARM TO THE PATIENT BECAUSE OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15703495 ↗
• MalfunctionSep 13, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  AN EMAIL WAS RECIEVED FROM A CUSTOMER ASKING WHY THEY RECEIVED A 3F SYNTEL OTW EMBOLECTOMY CATHETER WHEN THEY HAD ORDERED A 5F. IN DIGGING INTO THIS WE UNCOVERED THAT WHILE THE IFU LISTS ALL OF THE CATHETERS AS 5F DIAMETER, OUR PRODUCT LABELS LIST THEM AS 3F-7F (THE CORRESPONDING SIZE WHICH EACH REPLACES BASED ON BALLOON SIZE). THIS IS IDENTIFIED AS A LABELING ISSUE THAT IS NOT LIKELY TO CAUSE ADVERSE HEALTH CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15414098 ↗
• MalfunctionSep 8, 2022Material Rupture; Material Rupture

  THE SYNTEL SILICONE OVER-THE-WIRE EMBOLECTOMY CATHETER WAS USED IN A THROMBECTOMY OF A DIALYSIS PATIENT. AFTER PREPARING THE PRODUCT, THE CATHETER TIP WAS INSERTED INTO THE VEIN. WHEN THE BALLOON WAS INFLATED AND THE THROMBUS REMOVAL WAS STARTED, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER WITHOUT ANY PROBLEMS. THE PATIENT IS FINE. NO HEALTH DAMAGE HAPPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15381440 ↗
• MalfunctionAug 24, 2022Material Rupture; Material Rupture

  THE SYNTEL SILICONE OVER-THE-WIRE EMBOLECTOMY CATHETER WAS USED IN A THROMBECTOMY OF A DIALYSIS PATIENT. AFTER PREPARING THE PRODUCT, THE ARTIFICIAL BLOOD VESSEL WAS INCISED AND THE CATHETER TIP WAS INSERTED INTO THE VEIN. WHEN THE BALLOON WAS INFLATED AND THE THROMBUS REMOVAL IN THE ARTIFICIAL BLOOD VESSEL (WITH SLIGHT CALCIFICATION) WAS STARTED, THE BALLOON WAS RUPTURED EASILY. A SECOND PRODUCT FROM THE SAME LOT WAS PREPARED AND USED FOR THIS OPERATION. WHEN THE THROMBUS WAS ATTEMPTED TO REMOVE FROM THE ARTIFICIAL BLOOD VESSEL AND THE VENOUS ANASTOMOSIS (WITH MILD STENOSIS), THE BALLOON WAS RUPTURED. THE PHYSICIAN PREPARED THE THIRD CATHETER AND COMPLETED THE PROCEDURE WITHOUT ANY PROBLEMS. THE PATIENT IS FINE. NO HEALTH DAMAGE HAPPENED. THIS IS REPORT 1 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15287002 ↗
• MalfunctionAug 24, 2022Material Rupture; Material Rupture

  THE SYNTEL SILICONE OVER-THE-WIRE EMBOLECTOMY CATHETER WAS USED IN A THROMBECTOMY OF A DIALYSIS PATIENT. AFTER PREPARING THE PRODUCT, THE ARTIFICIAL BLOOD VESSEL WAS INCISED AND THE CATHETER TIP WAS INSERTED INTO THE VEIN. WHEN THE BALLOON WAS INFLATED AND THE THROMBUS REMOVAL IN THE ARTIFICIAL BLOOD VESSEL (WITH SLIGHT CALCIFICATION) WAS STARTED, THE BALLOON WAS RUPTURED EASILY. A SECOND PRODUCT FROM THE SAME LOT WAS PREPARED AND USED FOR THIS OPERATION. WHEN THE THROMBUS WAS ATTEMPTED TO REMOVE FROM THE ARTIFICIAL BLOOD VESSEL AND THE VENOUS ANASTOMOSIS (WITH MILD STENOSIS), THE BALLOON WAS RUPTURED. THE PHYSICIAN PREPARED THE THIRD CATHETER AND COMPLETED THE PROCEDURE WITHOUT ANY PROBLEMS. THE PATIENT IS FINE. NO HEALTH DAMAGE HAPPENED. THIS IS REPORT 2 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15286999 ↗
• MalfunctionAug 18, 2022Material Rupture; Material Rupture

  THE SYNTEL SILICONE OVER-THE-WIRE EMBOLECTOMY CATHETER WAS USED IN A THROMBUS REMOVAL OF THE DIALYSIS PATIENT. AFTER PREPARING THE PRODUCT, THE ARTIFICIAL BLOOD VESSEL WAS INCISED AND THE CATHETER TIP WAS INSERTED INTO THE VEIN. THE BALLOON RUPTURED SOON AFTER IT WAS INFLATED IN THE VEIN AND THROMBUS REMOVAL WAS STARTED. A SECOND PRODUCT FROM THE SAME LOT WAS PREPARED AND USED FOR THIS OPERATION, BUT THE BALLOON ALSO RUPTURED. SO, A THIRD PRODUCT WAS PREPARED AND USED. THE OPERATION WAS COMPLETED USING IT WITHOUT ANY PROBLEMS. THE PATIENT IS FINE. NO HEALTH DAMAGE HAPPENED. THIS IS REPORT 2 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15254766 ↗
• MalfunctionAug 18, 2022Material Rupture; Material Rupture

  THE SYNTEL SILICONE OVER-THE-WIRE EMBOLECTOMY CATHETER WAS USED IN A THROMBUS REMOVAL OF THE DIALYSIS PATIENT. AFTER PREPARING THE PRODUCT, THE ARTIFICIAL BLOOD VESSEL WAS INCISED AND THE CATHETER TIP WAS INSERTED INTO THE VEIN. THE BALLOON RUPTURED SOON AFTER IT WAS INFLATED IN THE VEIN AND THROMBUS REMOVAL WAS STARTED. A SECOND PRODUCT FROM THE SAME LOT WAS PREPARED AND USED FOR THIS OPERATION, BUT THE BALLOON ALSO RUPTURED. SO, A THIRD PRODUCT WAS PREPARED AND USED. THE OPERATION WAS COMPLETED USING IT WITHOUT ANY PROBLEMS. THE PATIENT IS FINE. NO HEALTH DAMAGE HAPPENED. THIS IS REPORT 1 OF 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15254710 ↗
• MalfunctionAug 11, 2022Material Rupture; Material Rupture

  THE BALLOON OF THE SYNTEL OVER-THE-WIRE EMBOLECTOMY CATHETER RUPTURED ON THE FIRST INFLATION DURING A THROMBECTOMY PROCEDURE. THE SURGEON USED ANOTHER CATHETER FOR THE PROCEDURE. THERE WAS NO HARM TO THE PATIENT BECAUSE OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15213795 ↗
• MalfunctionJul 21, 2022Material Rupture; Material Rupture

  THE BALLOON OF THE SYNTEL OVER-THE-WIRE EMBOLECTOMY CATHETER RUPTURED DURING AN EMBOLECTOMY PROCEDURE. THE BALLOON RUPTURED DURING THE FIRST PASS WHEN IT WAS INFLATED IN THE PATIENT'S BLOOD VESSEL. SO, THE SURGEON USED ANOTHER CATHETER FOR THE PROCEDURE. THERE WAS NO HARM TO THE PATIENT BECAUSE OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15079782 ↗
• MalfunctionJun 2, 2022Inflation Problem; Inflation Problem

  THE BALLOON OF THE SYNTEL OVER-THE-WIRE EMBOLECTOMY CATHETER RUPTURED DURING AN EMBOLECTOMY PROCEDURE. SO, THE SURGEON USED ANOTHER CATHETER FOR THE PROCEDURE. THERE WAS NO HARM TO THE PATIENT BECAUSE OF THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14572896 ↗

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-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
• 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