Syntel Silicone Embolectomy Catheter A4F05Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840663109661), received between Jan 18, 2023 and Jan 18, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 18, 2023Material Rupture; Material Rupture

  IT WAS INITIALLY REPORTED THAT THE PRODUCT WAS REMOVED FROM THE PACKAGE AND DURING THE PRE-USE CHECK THE CATHETER COULD NOT BE USED DUE TO LEAKAGE FROM THE BALLOON. HOWEVER, INSPECTION OF THE DEVICE PERFORMED ON 19DEC2022 DETERMINED THAT THE RETURNED PRODUCT HAD BEEN USED AND FOUND THE BALLOON TO BE RUPTURED. DUE TO THE DEVICE INSPECTION, THIS EVENT WAS REASSESSED TO BE A REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16196288 ↗

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