TYSHAK II® 611939Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046964339394), received between Dec 8, 2016 and Dec 8, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Burst Container or Vessel” (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.

• MalfunctionDec 8, 2016Burst Container or Vessel

  AS PER THE REPORT RECEIVED FROM THE DISTRIBUTOR: "BALLOON BURST PRIOR TO FULL INFLATION, TEAR WAS CIRCUMFERENTIAL (POSSIBLY SOME LONGITUDINAL TEAR ALSO). WHILE ATTEMPTING TO PULL BALLOON OUT OF THE BODY OVER THE WIRE, AS THE RUPTURED BALLOON GOT NEAR THE SHEATH, THE BALLOON CLAMPED DOWN ONTO THE WIRE. WITH CONTINUED PULLING, BALLOON STRETCHED TIGHTLY ONTO THE WIRE, THEN SHAFT BROKE. APPROX 2/3 OF BALLOON CAME OUT THROUGH THE SHEATH, REMAINDER OF THE BALLOON WAS STUCK ON THE WIRE, NEAR THE SHEATH. THERE WAS A THIN LAYER OF BALLOON SHAFT STUCK ON THE WIRE (CIRCUMFERENTIALLY) THAT PREVENTED PHYSICIAN FROM ADVANCING ANYTHING OVER THE WIRE. PHYSICIAN USED A SCALPEL TO SCRAPE THIS THIN LAYER OF BALLOON SHAFT OFF THE WIRE. PHYSICIAN INCLUDED SOME OF THE SCRAPED MATERIAL IN THE PLASTIC PACKAGE WITH BALLOON PIECES. PHYSICIAN EXCHANGED THE 10 FR SHEATH FOR A 14 FRENCH SHORT SHEATH, AND ADVANCED A 10MM SNARE OVER THE WIRE, PAST THE BALLOON AND TO END OF THE WIRE (WHICH WAS NOW IN THE RIGHT ATRIUM). PHYSICIAN TIGHTENED THE SNARE ONTO THE WIRE, THEN PULLED EVERYTHING INTO THE 14 FR SHEATH (A 14 FR SHEATH WAS USED TO MAKE SURE SHEATH WAS LARGE ENOUGH TO ASSURE ALL BALLOON FRAGMENTS WOULD PULL SA

  Patient problems: Foreign Body In Patient

  MAUDE report 6156116 ↗

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