TYSHAK II® 611934Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04046964339295), received between Jan 17, 2018 and Jan 30, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2020Material Rupture

  AS PER THE REPORT FROM THE USER FACILITY / DISTRIBUTOR - BALLOON RUPTURED. AN INFLATION DEVICE WAS USED WITH A 20CC SYRINGE ATTACHED TO THE SIDEPORT. A 10FR TERUMO INTRODUCER SHEATH WAS USED. THE CATHETER SHAFT WAS NOT KINKED. THERE WAS NOTHING UNUSUAL ABOUT THE PATIENT ANATOMY. THE PATIENT WAS STABLE POST PROCEDURE. UPDATE - 1/13/2020 - IN AN EMAIL FROM THE ACCOUNT: THE INDICATION THE PHYSICIAN WAS USING THE BALLOON FOR WAS ILIAC STENOSIS. AN XXL ESOPHAGEAL BALLOON WAS USED TO COMPLETE THE PROCEDURE. UPDATE - 1/15/2020 - IN AN EMAIL FROM THE ACCOUNT: AN INFLATION SERVICE WITH PRESSURE GAUGE WAS USED. THE GUIDEWIRE SIZE AND TYPE IS UNKNOWN.

  Patient problems: Stenosis

  MAUDE report 9649315 ↗
• MalfunctionJan 17, 2018Material Rupture

  AS PER THE REPORT RECEIVED FROM BIS: "THE PRODUCT WAS USED ON THE AORTIC VALVE. THE BALLOON RUPTURED. A HAND SYRINGE INFLATION WAS USED."

  Patient problems: No Information

  MAUDE report 7201185 ↗

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