Syntel Silicone Embolectomy Catheter A4F07Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840663109685), received between Feb 6, 2023 and Feb 6, 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.

• MalfunctionFeb 6, 2023Material Rupture; Material Rupture

  DURING AORTOILIAC RIGHT LOWER EXTREMITY ANGIOGRAM THE SYNTEL SINGLE LUMEN SPRING TIP EMBOLECTOMY CATHETER BALLOON BROKE.

  Patient problems: Insufficient Information

  MAUDE report 16308213 ↗

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