TYSHAK II® 611911Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046964338847), received between Feb 8, 2017 and Feb 8, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (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 18, 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.

• MalfunctionFeb 8, 2017Material Rupture

  AS PER THE INCIDENT REPORT FROM BIS: "BALLOON INFLATED OTW TO THE PULMONIC VALVE. INFLATED AT 3.5 ATM FOR 15 SECONDS, INFLATED AT 3.5 ATM FOR 10 SECONDS, INFLATED AT 2.0 ATM FOR 10 SECONDS. BALLOON RUPTURED. REMOVED BALLOON OTW, COULD NOT GET THE BALLOON THROUGH THE SHEATH, REMOVED ALL TOGETHER. UNSURE IF ALL OF THE BALLOON WAS REMOVED FROM THE BODY." A FOLLOW-UP REPORT WAS ALSO SENT TO NUMED FROM BIS WITH THIS ADDITIONAL INFORMATION: "IN A CONVERSATION THE BIS SALES SPECIALIST HAD WITH THE ACCOUNT: THE PHYSICIAN WAS USING THE BALLOON FOR PULMONIC VALVULOPLASTY. AN INFLATION DEVICE WITH PRESSURE GAUGE WAS USED - MERIT DIGITAL INFLATOR. A ST. JUDE FAST TRACK 8 FR INTRODUCER WAS USED. THE CATHETER SHAFT WAS NOT KINKED. THERE WAS NOTHING UNUSUAL ABOUT THE PATIENT ANATOMY. THEIR (SIC) WAS NO CHANGE IN THE PATIENT CONDITION POST PROCEDURE. NO SECOND BALLOON WAS USED TO COMPLETE THE PROCEDURE. THE BALLOON BURST AT 3.5 ATMS."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6311772 ↗

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