TYSHAK II® 611941Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046964339431), received between Apr 13, 2022 and Apr 13, 2022 — classified as 1 death.

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

1 other recall cover devices cleared under the same FDA submission (K003052, K931009); 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 16, 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.

• DeathApr 13, 2022Break; Off-Label Use; Break; Off-Label Use

  AS REPORTED TO NUMED BY THE DISTRIBUTOR /USER FACILITY - PHYSICIAN WAS USING THE TYSHAK BALLOON DURING A PROCEDURE AND THE BALLOON RUPTURED. THIS PATIENT EXPIRED DURING THE PROCEDURE. PHYSICIAN BELIEVES THE DEATH IS UNLIKELY RELATED TO THE BALLOON RUPTURE AND ATTRIBUTABLE MORE TO THE PRE-EXISTING CONDITIONS IN THIS PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 14105818 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K003052, K931009. One submission often covers many models, so check the product and lot details in each record.

• Z-0509-2010 · Sep 23, 2009 · Terminated
  IMPACT Catheters, Balloon Dilatation and Esophageal Dilatation Catheter, Model Number 307, STERILE, Rx only --- Common/Usual Name: PTA and Esophageal Catheter --- Manufactured f