TYSHAK II® 611938Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046964339370), received between Feb 4, 2022 and Feb 4, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Off-Label Use” (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.

• InjuryFeb 4, 2022Off-Label Use; Off-Label Use

  BALLOON BURST. AS PER THE INFORMATION PROVIDED BY THE U.S. DISTRIBUTOR, (B)(6), WHO IN TURN RECEIVED AN EMAIL FROM THE USER FACILITY THAT STATED." DR. (B)(6) HAD TO SNARE OUT ONE OF YOUR WEDGE CATHETERS LAST WEEK. THE BALLOON RUPTURE AND BROKE APART."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13452437 ↗

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