TYSHAK II® 611940Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04046964339417), received between Jun 27, 2017 and Aug 3, 2020 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 3, 2020Degraded; Material Rupture

  AS REPORTED TO NUMED FROM DISTRIBUTOR (B)(6) - UPON POSITIVE PREPARATION OF THE BALLOON DILATATION CATHETER OUTSIDE THE PATIENT'S BODY THE EVENT REPORTER STATED THE BALLOON "DISINTEGRATED" WITH AROUND 22ML OF SOLUTION IN THE BALLOON. THE BALLOON RUPTURED. NO PATIENT HARM. UPDATE (B)(6) 2020 FROM (B)(6) - IN A CONVERSATION WITH THE ACCOUNT: USED A 60CC SYRINGE WITH A 3 TO 1 SALINE TO CONTRAST RATIO AND PLACED APPROXIMATELY 21 TO 22 ML OF SOLUTION INTO THE BALLOON DURING POSITIVE PREPARATION. THE BALLOON RUPTURED / DISINTEGRATED. NO GUIDEWIRE WAS UTILIZED DURING PREPARATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10355939 ↗
• MalfunctionJul 31, 2020Material Rupture

  BALLOON BEING PREPPED BEFORE ENTERING THE BODY. BALLOON POPPED DURING PREP TIME WITHOUT FULL AMOUNT OF LIQUID IN BALLOON.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10349511 ↗
• InjuryNov 20, 2018Material Rupture; Physical Resistance/Sticking

  DESCRIPTION TAKEN DIRECTLY FROM A MEDWATCH REPORT RECEIVED DIRECTLY FROM THE USER FACILITY: WITH THE USE OF FLUOROSCOPIC AND VASCULAR ULTRASOUND GUIDANCE, THE RIGHT COMMON FEMORAL ARTERY WAS ACCESSED. ANGIOGRAPHY REVEALED GOOD CATHETER POSITIONING WITH A MICROPUNCTURE KIT AND A SINGLE PERCLOSE PROGLIDE DEVICE WAS PLACED AND THEN A 9 FRENCH SHEATH WITHOUT DIFFICULTY. HEPARIN WAS THEN ADMINISTERED AT FULL DOSAGE. DUE TO THE RIGHT FEMORAL ARTERY SHEATH, A PIGTAIL CATHETER WAS ADVANCED TO THE LEVEL OF THE EDWARDS SAPIEN VALVE AND THE VALVE WAS CROSSED WITHOUT DIFFICULTY. THROUGH THE PIGTAIL CATHETER, A SAFARI EXTRA SMALL WIRE WAS PLACED IN THE LV APEX AND THE PIGTAIL CATHETER WAS SUBSEQUENTLY REMOVED. OVER THIS WIRE, A TYSHAK 23 MM BALLOON WAS PASSED AND ACROSS THE NATIVE VALVE WITHOUT DIFFICULTY. RAPID VENTRICULAR PACING WAS PERFORMED WITH THE ASSISTANCE OF A PACEMAKER REP WITH A MAXIMUM RATE OF 170 WITH GOOD DROP IN SYSTOLIC PRESSURE AND VERY LOW PULSE PRESSURE. THE BALLOON IS FULLY INFLATED AND AT MAXIMUM INFLATION, THE BALLOON DID RUPTURE. THE BALLOON CATHETER WAS WITHDRAWN TO THE LEVEL OF THE SHEATH MAKING SURE THAT THE BALLOON MARKER ARE IN PLACE. THERE WAS SOME RESISTANCE TO REM

  Patient problems: Foreign Body In Patient; Ischemia

  MAUDE report 8090911 ↗
• MalfunctionJun 27, 2017Material Rupture

  AS PER THE REPORT FROM BIS - "DURING A VALVULOPLASTY PROCEDURE, PHYSICIAN HAD THE BALLOON RUPTURE UPON INFLATION. THERE WAS NOT HARM CAUSED TO THE PATIENT AND THE PROCEDURE ENDED UP WITH A GOOD RESULT, DESPITE THIS RUPTURE. THE CARDIAC OUTPUT PRIOR TO THE PROCEDURE WAS A 1.6 AND AFTER THE PROCEDURE IT WAS AN AVG OF 1.95. CALCIFICATION WAS NOTED AT THE PROCEDURE SITE. AN INFLATION DEVICE WITH PRESSURE GAUGE WAS NOT USED. THE ATM AT WHICH THE BALLOON RUPTURED IS UNKNOWN BECAUSE A SYRINGE WAS USED. THE CATHETER SHAFT WAS NOT KINKED. A 9F TERUMO PINNACLE SHEATH WAS USED. NO UNUSUAL PATIENT ANATOMY WAS REPORTED."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6669240 ↗

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