Skip to content

TYSHAK Mini® 611986Recalls & reported problems

B Braun Interventional Systems, Inc · PDC401 TYSHAK MINI 5MM 2CM · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046964339653), received between Dec 16, 2019 and Dec 16, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Material Rupture1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionDec 16, 2019Material Rupture

    AS PER THE REPORT FROM THE USER FACILITY / DISTRIBUTOR - PRE-DILATATION BALLOON TEST WITH CONTRAST BURST THE BALLOON. THE INDICATION THE PHYSICIAN WAS USING THE BALLOON FOR: COARCTATION OF THE AORTA / ANGIOPLASTY. AN INFLATION DEVICE WITH PRESSURE GAUGE WAS USED. A 4 FR INTRODUCER SHEATH WAS USED. THE CATHETER SHAFT WAS NOT KINKED. A 6MM TYSHAK MINI WAS USED TO COMPLETE THE PROCEDURE WITHOUT INCIDENT. THE BALLOON RUPTURED LONGITUDINALLY AND BELOW NOMINAL: 1-2 RBP.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9476551 ↗

Other Catheter, angioplasty, peripheral, transluminal devices

All Catheter, angioplasty, peripheral, transluminal devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.