TYSHAK II® 611932Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04046964339257), received between Aug 7, 2017 and Sep 22, 2022 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2022Burst Container or Vessel; Burst Container or Vessel

  AS REPORTED BY THE USER FACILITY / DISTRIBUTOR - DURING THE PROCEDURE (MITRAL VALVULOPLASTY), THE PHYSICIAN NOTICED THE BALLOON RUPTURED UNDER FLUOROSCOPY. THE BALLOON WAS SUCCESSFULLY REMOVED THROUGH THE SHEATH AND THE PRODUCT WAS SAVED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15462865 ↗
• MalfunctionDec 11, 2019Material Rupture

  AS PER THE REPORT FROM THE USER FACILITY / DISTRIBUTOR - DURING POSITIVE BALLOON PREPARATION AS INDICATED IN THE IFU, THE PHYSICIAN FILLED THE BALLOON WITH CONTRAST/SALINE MIXTURE (RATION UNKNOWN) TO A "SOFT" DILATED STATE WITH EITHER A 30 OR 60CC SYRINGE. UPON "PULLBACK" TO EXPEL AIR, THE PHYSICIAN NOTED THAT THE BALLOON BURST. THE NATURE OF THIS BURST WAS NOT KNOWN. THE CATHETER SHAFT WAS NOT KINKED. A 611937 PDC537 WAS USED TO COMPLETE THE PROCEDURE. IT IS UNKNOWN AT WHAT PRESSURE THE BALLOON RUPTURED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9449891 ↗
• MalfunctionAug 7, 2017Material Rupture

  AS PER THE REPORT FROM BIS - "CASE WAS A PULMONARY ARTERY ANGIOPLASTY AND THE BALLOON RUPTURED LONGITUDINALLY IN THE PULMONARY ARTERY. PHYSICIAN WAS ABLE TO SNARE AND REMOVE THE FRAGMENTED PIECE LEFT BEHIND. PATIENT IS FINE." ON (B)(6) 2017 UPDATE - "IN AN EMAIL FROM THE ACCOUNT: AN INFLATION DEVICE WITH PRESSURE GAUGE WAS USED. THE BALLOON BURST AT ABOUT 3-4 ATM. THE SHAFT WAS NOT KINKED. A 0.025 SUPER STIFF GUIDEWIRE WAS USED. A VIDA BALLOON WAS USED TO COMPLETE THE PROCEDURE. REGARDING THE PATIENT ANATOMY THE ACCOUNT NOTED: YES, IT WAS UNUSUAL AS THE TYSHAK II WAS USED ON A BIOPROSTHETIC VALVE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6771781 ↗

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