Syntel Silicone Embolectomy Catheter A4F04Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00840663109654), received between Aug 19, 2022 and Apr 5, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K901627); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 5, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT WHILE USING A SYNTEL SILICONE EMBOLECTOMY CATHETER - SPRING TIP FOR REMOVAL OF A CLOT THE BALLOON RUPTURED. THERE WAS NO INJURY TO THE PATIENT. THE OPERATION WAS SUCCESSFULLY COMPLETED WITH A REPLACEMENT DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16682219 ↗
• MalfunctionNov 30, 2022Material Rupture; Material Rupture

  BEFORE OF A SYNTEL SILICONE EMBOLECTOMY CATHETER - SPRING TIP, WHEN THE PHYSICIAN TRIED TO INFLATE THE BALLOON IT WAS NOTED THAT THE BALLOON RUPTURED. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15887423 ↗
• MalfunctionAug 19, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PRODUCT WAS PREPARED FOR EMBOLECTOMY IN THE AUTOLOGOUS BLOOD VESSELS OF DIALYSIS PATIENT. THE CATHETER WAS INSERTED INTO THE BLOOD VESSEL, THEN THE BALLOON WAS INFLATED. WHEN THE PHYSICIAN STARTED PULLING THE CATHETER FOR REMOVING THE CLOTS, THE BALLOON RUPTURED WITHOUT ANY RESISTANCE. WHEN HE TOOK THE CATHETER OUT OF THE VESSEL AND CHECKED IT, THERE WAS SOMETHING LIKE A LIGATURE AND A PIECE OF THE BALLOON ON THE CATHETER TIP. HE GAVE UP USING THIS PRODUCT AND REPLACED IT WITH ANOTHER CATHETER OF THE SAME SIZE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING THAT CATHETER. THE PATIENT IS FINE. THERE WAS NO HEALTH IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15262631 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K901627. One submission often covers many models, so check the product and lot details in each record.

• Z-2446-2012 · Aug 9, 2012 · Terminated
  Embolectomy Catheters (Models A44XX, A4FXX, CE0XXXST, and CE0XXX): Model Numbers & Description: A4402, 3F-40CM, SYNTEL RT-EMB; A4403, 3F-80CM, SYNTEL RT-EMB; A4404, 4F-40CM, SYNTE