TYSHAK II® 611937Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046964339356), received between Oct 29, 2021 and Oct 29, 2021 — classified as 1 malfunction.

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.

• MalfunctionOct 29, 2021Off-Label Use; Off-Label Use

  AS PER THE REPORT FROM THE USER FACILITY / DISTRIBUTOR - PATIENT BROUGHT IN FOR A VALUVLOPLASTY. DURING THE PROCEDURE THE VALVULOPLASTY BALLOON RUPTURED. TYSHAK 22MM AORTIC BALLOON RUPTURED WHILE INFLATED ACROSS TAVR AORTIC VALVE. WE BELIEVE THAT THE TAVR STRUT CAUGHT THE BALLOON. DURING INFLATION, THE SYRINGE FILLED WITH BLOOD AND THE BALLOON WAS NOTED TO BE RUPTURED. SOME OF THE BALLOON GOT CAUGHT ON THE ARTIFICIAL VALVE. A 50CC SYRINGE WITH A 3 WAY STOPCOCK WAS USED. MONITORED BALLOON INFLATION UNDER FLUORO. INTRODUCER 7FR X 10CM TERUMO. GUIDEWIRE: .035 X 260 LUNDERQUIST. THE CATHETER SHAFT WAS NOT KINKED. THERE WAS NOTHING UNUSUAL ABOUT THE PATIENT ANATOMY. PREEXISTING CHARACTERISTICS THAT MAY HAVE CONTRIBUTED TO THE EVENT: CORONARY HEART DISEASE. THE PATIENT'S CONDITION POST PROCEDURE: STABLE, TRANSFERRED TO CARDIOVASCULAR ICU. ANOTHER BALLOON WAS NOT USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12719173 ↗

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