TYSHAK II® 611929Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04046964339202), received between Apr 25, 2019 and Apr 16, 2021 — classified as 1 death, 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 16, 2021Off-Label Use; Off-Label Use

  PER THE REPORT FROM THE USER FACILITY / DISTRIBUTOR - BALLOON RUPTURE OF AN 18MM X 5CM TYSHAK II BALLOON INFLATED TO RBP (BUT NOT GREATER THAN RBP). AN INFLATION DEVICE WITH PRESSURE GAUGE WAS USED. THE INDICATION THE PHYSICIAN WAS USING THE BALLOON FOR WAS STATIC ATRIAL SEPTOSTOMY. THE SIZE AND TYPE OF INTRODUCER SHEATH BEING USED: 8FR TERUMO. THE RUPTURE WAS CIRCUMFERENTIAL AND THE PHYSICIAN COULD NOT RISK THE WIRE POSITION WHILE ON VA ECMO, THEREFORE PERFORMED A PARTIAL CUT DOWN OF THE FEMORAL VEIN TO LOCATE THE DISTAL BALLOON FRAGMENT (WHICH HAD INVERTED ON ITSELF) AND REMOVED IT. PATIENT CONDITION POST PROCEDURE WAS CRITICAL, HOWEVER NOT RELATED TO THE BALLOON RUPTURE.

  Patient problems: Insufficient Information

  MAUDE report 11678262 ↗
• MalfunctionMay 11, 2020Material Rupture

  PER THE REPORT FROM THE MEDWATCH FORM / DISTRIBUTOR - THE BALLOON WAS HAND INFLATED NOMINAL SIZE (18MM) USING A VAC-LOK LOCKING SYRINGE. AFTER REACHING ITS NOMINAL SIZE USING FLUOROSCOPY, THE BALLOON RUPTURED. PHYSICIAN IMMEDIATELY PULLED A NEGATIVE PRESSURE ON THE VAC-LOK'S PLUNGER AND LOCKED IT. BLOOD OBSERVED RETURNING FROM THE BALLOON PORT (WHICH IS SUPPOSED TO BE A CLOSED SYSTEM). THE BALLOON WAS WITHDRAWN FROM THE PATIENT WITH VAC-LOK PLUNGER LOCKED ON NEGATIVE. THERE WERE EKG CHANGES AFTER BALLOON RUPTURING. CONCERN IF THERE MAY HAVE BEEN SOME AIR/MICRO-BUBBLES DISPURSED DURING THE BALLOON RUPTURING. THE BALLOON RUPTURED FROM EITHER A SHARP CALCIFIC EDGE FROM THE AORTIC VALVE AND/OR BEING INFLATED ADJACENT TO THE "CRIMPED" UNDEPLOYED VALVE CAGE LOADED ON ITS DELIVERY SYSTEM MAY HAVE RUPTURED THE BALLOON. ONCE REMOVED IT WAS CONFIRMED THE BALLOON RUPTURED. PROCEDURE COMPLETED. NO HARM TO PATIENT. 4/24/2020: IN A CONVERSATION WITH THE BIS SALES SPECIALIST AND THE ACCOUNT: A 9FR SHEATH WAS USED. THE CATHETER SHAFT WAS NOT KINKED. THE BALLOON WAS REMOVED AND REPLACED WITH A MARKER PIGTAIL. THE REMOVED BALLOON WAS INTACT, NO MISSING PARTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10043618 ↗
• DeathSep 26, 2019Burst Container or Vessel

  MEDWATCH REPORT RECEIVED FROM DISTRIBUTOR (B)(4), WHO RECEIVED IT FROM THE FDA - VALVULOPLASTY BALLOON WAS INFLATED AND THEN BURST. IT IS BELIEVED THAT THE BALLOON RUPTURED DUE TO THE HEAVY CALCIUM ON THE PATIENT'S VALVE WHICH POKED A HOLE IN THE PLASTIC OF THE BALLOON. INFORMATION FROM THE ACCOUNT THAT WAS SENT TO (B)(4) AS A FOLLOW-UP - "IT IS UNKNOWN IF AN INFLATION DEVICE WITH PRESSURE GAUGE WAS USED. THE PATIENT CONDITION POST PROCEDURE: PATIENT CODED DURING THE PROCEDURE AND DID NOT SURVIVE. PHYSICIAN SAID THAT PATIENT DID NOT CODE AS A RESULT OF THE RUPTURE. IT WAS AORTIC. THE TYPE AND SIZE OF GUIDEWIRE USED IS UNKNOWN AND IT IS UNKNOWN IF THE SHAFT WAS KINKED."

  Patient problems: Cardiac Arrest; Death

  MAUDE report 9123111 ↗
• InjuryApr 25, 2019Entrapment of Device; Material Rupture

  AS RECEIVED FROM NUMED'S DISTRIBUTOR/USER FACILITY: "THE BALLOON CATHETER RUPTURED DURING A BAV. IT THEN GOT STUCK IN THE PATIENT, WHO REQUIRED SURGICAL INTERVENTION. 1ST INFLATION WAS FOR 10 SECONDS. BURST OCCURRED DURING THE SECOND INFLATION. THE ENTIRE BALLOON WAS PERCEIVED TO HAVE BEEN PULLED BACK INTO THE FEMORAL SHEATH, HOWEVER IT COULD NOT BE REMOVED FROM THE SHEATH. THE SHEATH WAS EXTRACTED FROM THE PATIENT, BUT THE DISTAL HALF OF THE BALLOON REMAINED STUCK IN THE PATIENT'S FEMORAL ARTERY. VASCULAR SURGEON WAS CALLED TO INTERVENE. DEVICE WAS SUCCESSFULLY REMOVED BY SURGEON UNDER SURGICAL TECHNIQUE. ON (B)(6) 2019 - IN AN EMAIL FROM THE ACCOUNT :AN INFLATION DEVICE WITH PRESSURE GAUGE WAS NOT USED. IT WAS HAND INFLATED WITH A MERIT MEDICAL 30CC SYRINGE. THE 8FR, 25CM TERUMO INTRODUCER WAS USED. THE CATHETER SHAFT WAS NOT KINKED. REGARDING THE PATIENT ANATOMY: PROSTHETIC AORTIC VALVE, ILIAC STENTS (HENCE LONG SHEATH). THE PATIENT WAS STABLE POST PROCEDURE. A SECOND BALLOON WAS NOT USED TO COMPLETE THE PROCEDURE".

  Patient problems: Foreign Body In Patient

  MAUDE report 8549804 ↗

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