TYSHAK II® 611936Recalls & reported problems
B Braun Interventional Systems, Inc · PDC536 22MM X 4CM BALL CATH TYSHA II STD · Class 2
All models of TYSHAK II (12)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046964339332), received between Sep 14, 2017 and Sep 14, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Material Rupture” (1 report).
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
Device problems
- Material Rupture1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 14, 2017Material Rupture
AS REPORTED BY THE DISTRIBUTOR BIS "BALLOON RUPTURED DURING A CASE. IN AN EMAIL FROM THE ACCOUNT (B)(6) 2017: BALLOON USED FOR VALVULOPLASTY, REPORTED TO HAVE RUPTURED. WHILE ATTEMPTING TO REMOVE THE CATHETER, THE PROVIDER WAS UNABLE TO REMOVE. PATIENT HAD TO HAVE CATHETER REMOVED SURGICALLY. BALLOON WAS BEING USED FOR SEVERE AORTIC STENOSIS. IT IS NOT DOCUMENTED WHETHER OR NOT AN INFLATION DEVICE WITH PRESSURE GAUGE WAS USED. AN 8FR STANDARD SHEATH WAS USED. IT IS UNKNOWN IF THERE WAS ANYTHING UNUSUAL ABOUT THE PATIENT ANATOMY. POST PROCEDURE PATIENT WAS TRANSFERRED TO THE OR FOR CATHETER REMOVAL, VITAL SIGNS WERE WITHIN NORMAL LIMITS. A SECOND BALLOON WAS NOT USED TO COMPLETE THE PROCEDURE. IT IS NOT DOCUMENTED AT WHAT ATM THE BALLOON RUPTURED."
Patient problems: Foreign Body In Patient
MAUDE report 6865462 ↗
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 · TerminatedIMPACT Catheters, Balloon Dilatation and Esophageal Dilatation Catheter, Model Number 307, STERILE, Rx only --- Common/Usual Name: PTA and Esophageal Catheter --- Manufactured f
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- Coyote™ H74939185202210Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal200 reports
- Coyote™ ES H74939135254010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal127 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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