TYSHAK IIRecalls & reported problems across all models
B Braun Interventional Systems, Inc · 12 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 25
- Deaths reported
- 2
- Injuries reported
- 7
- Recalls
- 0
We found 12 models of TYSHAK II by B Braun Interventional Systems, Inc in the FDA's device registry (GUDID). Together they are named in 25 adverse event reports in the FDA's MAUDE database, received between Dec 8, 2016 and Apr 15, 2026 — classified as 2 deaths, 7 injuries, 16 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (16 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported TYSHAK II problems
Device problems
- Material Rupture16
- Off-Label Use5
- Burst Container or Vessel4
- Break2
- Degraded1
- Entrapment of Device1
- Material Separation1
- Physical Resistance/Sticking1
Patient problems
- No Known Impact Or Consequence To Patient7
- Foreign Body In Patient5
- No Clinical Signs, Symptoms or Conditions4
- Insufficient Information3
- No Consequences Or Impact To Patient2
- Aspiration/Inhalation1
- Cardiac Arrest1
- Death1
TYSHAK II models
12 models, most reported first. Each model has its own page with its reports, recalls and device details.
- TYSHAK II® 611929Catheter, angioplasty, peripheral, transluminal1 death4 reports
- TYSHAK II® 611940CATHETER, PERCUTANEOUS4 reports
- TYSHAK II® 611928CATHETER, PERCUTANEOUS3 reports
- TYSHAK II® 611930CATHETER, PERCUTANEOUS3 reports
- TYSHAK II® 611932CATHETER, PERCUTANEOUS3 reports
- TYSHAK II® 611934Catheter, angioplasty, peripheral, transluminal2 reports
- TYSHAK II® 611911Catheter, angioplasty, peripheral, transluminal1 report
- TYSHAK II® 611936Catheter, angioplasty, peripheral, transluminal1 report
- TYSHAK II® 611937CATHETER, PERCUTANEOUS1 report
- TYSHAK II® 611938CATHETER, PERCUTANEOUS1 report
- TYSHAK II® 611939CATHETER, PERCUTANEOUS1 report
- TYSHAK II® 611941CATHETER, PERCUTANEOUS1 death1 report
Recent TYSHAK II adverse event reports
The 15 most recent reports across all models, 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 ↗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 ↗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 ↗DeathApr 13, 2022Break; Off-Label Use; Break; Off-Label Use
AS REPORTED TO NUMED BY THE DISTRIBUTOR /USER FACILITY - PHYSICIAN WAS USING THE TYSHAK BALLOON DURING A PROCEDURE AND THE BALLOON RUPTURED. THIS PATIENT EXPIRED DURING THE PROCEDURE. PHYSICIAN BELIEVES THE DEATH IS UNLIKELY RELATED TO THE BALLOON RUPTURE AND ATTRIBUTABLE MORE TO THE PRE-EXISTING CONDITIONS IN THIS PATIENT.
Patient problems: Insufficient Information
MAUDE report 14105818 ↗InjuryFeb 4, 2022Off-Label Use; Off-Label Use
BALLOON BURST. AS PER THE INFORMATION PROVIDED BY THE U.S. DISTRIBUTOR, (B)(6), WHO IN TURN RECEIVED AN EMAIL FROM THE USER FACILITY THAT STATED." DR. (B)(6) HAD TO SNARE OUT ONE OF YOUR WEDGE CATHETERS LAST WEEK. THE BALLOON RUPTURE AND BROKE APART."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13452437 ↗MalfunctionOct 29, 2021Off-Label Use; Off-Label Use
AS PER THE REPORT FROM THE USER FACILITY / DISTRIBUTOR - PATIENT BROUGHT IN FOR A VALUVLOPLASTY. DURING THE PROCEDURE THE VALVULOPLASTY BALLOON RUPTURED. TYSHAK 22MM AORTIC BALLOON RUPTURED WHILE INFLATED ACROSS TAVR AORTIC VALVE. WE BELIEVE THAT THE TAVR STRUT CAUGHT THE BALLOON. DURING INFLATION, THE SYRINGE FILLED WITH BLOOD AND THE BALLOON WAS NOTED TO BE RUPTURED. SOME OF THE BALLOON GOT CAUGHT ON THE ARTIFICIAL VALVE. A 50CC SYRINGE WITH A 3 WAY STOPCOCK WAS USED. MONITORED BALLOON INFLATION UNDER FLUORO. INTRODUCER 7FR X 10CM TERUMO. GUIDEWIRE: .035 X 260 LUNDERQUIST. THE CATHETER SHAFT WAS NOT KINKED. THERE WAS NOTHING UNUSUAL ABOUT THE PATIENT ANATOMY. PREEXISTING CHARACTERISTICS THAT MAY HAVE CONTRIBUTED TO THE EVENT: CORONARY HEART DISEASE. THE PATIENT'S CONDITION POST PROCEDURE: STABLE, TRANSFERRED TO CARDIOVASCULAR ICU. ANOTHER BALLOON WAS NOT USED TO COMPLETE THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12719173 ↗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 ↗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 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 ↗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 ↗MalfunctionJan 30, 2020Material Rupture
AS PER THE REPORT FROM THE USER FACILITY / DISTRIBUTOR - BALLOON RUPTURED. AN INFLATION DEVICE WAS USED WITH A 20CC SYRINGE ATTACHED TO THE SIDEPORT. A 10FR TERUMO INTRODUCER SHEATH WAS USED. THE CATHETER SHAFT WAS NOT KINKED. THERE WAS NOTHING UNUSUAL ABOUT THE PATIENT ANATOMY. THE PATIENT WAS STABLE POST PROCEDURE. UPDATE - 1/13/2020 - IN AN EMAIL FROM THE ACCOUNT: THE INDICATION THE PHYSICIAN WAS USING THE BALLOON FOR WAS ILIAC STENOSIS. AN XXL ESOPHAGEAL BALLOON WAS USED TO COMPLETE THE PROCEDURE. UPDATE - 1/15/2020 - IN AN EMAIL FROM THE ACCOUNT: AN INFLATION SERVICE WITH PRESSURE GAUGE WAS USED. THE GUIDEWIRE SIZE AND TYPE IS UNKNOWN.
Patient problems: Stenosis
MAUDE report 9649315 ↗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 ↗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 ↗
Other B Braun Interventional Systems, Inc products
All B Braun Interventional Systems, Inc devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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