TYSHAK Mini® 611989Recalls & reported problems
B Braun Interventional Systems, Inc · PDC404 TYSHAK MINI 8MM 2CM · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 04046964339714), received between Oct 25, 2017 and Oct 25, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Deflation Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Deflation Problem1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 25, 2017Deflation Problem
AS PER THE MEDWATCH REPORT RECEIVED FROM THE FDA - "WHILE PREPPING THE BALLOON, THE BALLOON WOULD NOT DEFLATE COMPLETELY. A NEW BALLOON WAS OBTAINED AND PROCEDURE WAS COMPLETED. ORIGINAL DEVICE WAS NOT USED ON PATIENT. REPORTEDLY, THERE WAS NO HARM TO PATIENT."
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6976383 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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