TYSHAK II® 611930Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04046964339219), received between Aug 29, 2017 and Apr 15, 2026 — 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 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.

• MalfunctionApr 15, 2026Material Rupture

  THE BALLOON WAS INFLATED AND BURST, CAUSING THE PATIENT TO ASPIRATE CONTRAST.

  Patient problems: Aspiration/Inhalation

  MAUDE report 24885507 ↗
• MalfunctionNov 3, 2020Break; Off-Label Use; Break; Off-Label Use

  AS REPORTED TO NUMED BY THE USER FACILITY / DISTRIBUTOR - " BAV PROCEDURE. THERE WAS A BRIEF INFLATION AND THEN THE BALLOON BURST. ACCOUNT INDICATED THAT THE PROCEDURE WAS SUCCESSFUL. THE ENTIRE BALLOON WAS REMOVED AFTER THE RUPTURE. AN INFLATION DEVICE WITH A PRESSURE GAUGE WAS USED. PHYSICIAN DOES NOT KNOW WHAT NUMBER IT WAS ON WHEN IT BURST. THE GUIDEWIRE USED WAS 0.035. IT IS UNKNOWN WHETHER OR NOT THE SHAFT WAS KINKED OR IF THERE WAS ANYTHING UNUSUAL WITH THE PATIENT ANATOMY. THE PATIENT WAS FINE POST PROCEDURE." "THERE WAS A BRIEF INFLATION AND THEN THE BALLOON BURST." NO ADVERSE EVENTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10780042 ↗
• MalfunctionAug 29, 2017Material Rupture; Material Separation

  AS PER THE MEDWATCH REPORT RECEIVED FROM THE FDA/USER FACILITY: "DURING PRE-DILATATION THE BALLOON RUPTURED AND WAS REMOVED BUT IT HAD SEPARATED FROM THE INNER SHEATH." UPDATED REPORT FROM BIS "IN AN EMAIL FROM THE ACCOUNT: THE CATHETER WAS USED FOR AORTIC VALVULOPLASTY. THERE WERE NO NOTES ABOUT AN INFLATION DEVICE BEING USED. THERE WAS NO MENTION OF ANY PRESSURE AT THE TIME OF RUPTURE. A 16FR GORE DRY-SEAL SHEATH WAS USED. THE CATHETER SHAFT WAS NOT KINKED. THERE IS A MENTION OF STEEP HORIZONTAL AORTIC ANGLE IN EXCESS OF 60 DEGREES. THERE IS MENTION OF HEAVY VALVE CALCIFICATION. CONDITION OF THE PATIENT WAS STABLE. ONCE DEFECTIVE BALLOON WAS REMOVED A 29 MM EVOLUT PRO CORE VALVE WAS LOADED INTO THE DELIVERY CATHETER."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6826590 ↗

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