TYSHAK II® 611928Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04046964339172), received between Jan 6, 2017 and Oct 24, 2025 — classified as 2 injuries, 1 malfunction.

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 18, 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.

• InjuryOct 24, 2025Material Rupture; Material Rupture

  AS PER THE REPORT FROM THE USER FACILITY / DISTRIBUTOR - DURING SCHEDULED RIGHT HEART CATHETERIZATION AND BALLOON ANGIOPLASTY OF PULMONIC VALVE, TYSHAK II 18.0MMX4.0MM BALLOON INFLATED TO BURST PRESSURE OF 2.0 ATM. BALLOON RUPTURED. TIP OF THE BALLOON SHEARED AWAY FROM BODY OF BALLOON CATHETER AND REMAINED IN BODY AS CATHETER REMOVED. INTRACARDIAC ECHO INITIATED IN ATTEMPT TO VISUALIZE RETAINED BALLOON TIP. UNABLE TO OBTAIN ANY IMAGES. ALTERNATE BALLOON USED TO COMPLETE PROCEDURE. PROCEDURE ENDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23381688 ↗
• InjuryJul 23, 2024Material Rupture; Material Rupture

  DURING A VALVULOPLASTY, THE BALLOON RUPTURED.

  Patient problems: Insufficient Information

  MAUDE report 19806914 ↗
• MalfunctionJan 6, 2017Burst Container or Vessel

  AS PER THE REPORT RECEIVED FROM BIS: "BALLOON WAS INFLATED WITH A SYRINGE AND BURST. PHYSICIAN WAS USING THE BALLOON FOR TAVR - EXISTING STENT INSIDE STENT IN VALVE WHEN BALLOON WAS INFLATED. A 14FR DRY SEAL INTRODUCER SHEATH WAS USED. THE CATHETER SHAFT WAS NOT KINKED. A TYSHAK II WAS USED TO COMPLETE THE PROCEDURE WITHOUT INCIDENT. THE PATIENT WAS FINE POST PROCEDURE - THE PATIENT HAD 2 STENTS IN THE VALVE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6230017 ↗

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