Z-MED II™ 611660Recalls & reported problems
B Braun Interventional Systems, Inc · SO071 ZMED II 28X4X100 · Class 2
Data updated Oct 18, 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 04046964335815), received between Feb 1, 2017 and Feb 1, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Burst Container or Vessel” (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 18, 2026.
Most reported problems
Device problems
- Burst Container or Vessel1
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.
MalfunctionFeb 1, 2017Burst Container or Vessel
AS PER THE REPORT FROM BIS - "BALLOON BURST CIRCUMFERENTIALLY."
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6292177 ↗
Other Balloon aortic valvuloplasty devices
- TRUE DILATATION 0224512Bard Peripheral Vascular, Inc. · Balloon aortic valvuloplasty23 reports
- TRUE DILATATION 0204511Bard Peripheral Vascular, Inc. · Balloon aortic valvuloplasty21 reports
- TRUE DILATATION 0244512Bard Peripheral Vascular, Inc. · Balloon aortic valvuloplasty2 deaths19 reports
- TRUE DILATATION 0184511Bard Peripheral Vascular, Inc. · Balloon aortic valvuloplasty12 reports
- TRUE DILATATION 0264513Bard Peripheral Vascular, Inc. · Balloon aortic valvuloplasty11 reports
- TRUE DILATATION 0214512Bard Peripheral Vascular, Inc. · Balloon aortic valvuloplasty10 reports
- TRUE FLOW TF0203511Bard Peripheral Vascular, Inc. · Balloon aortic valvuloplasty10 reports
- TRUE DILATATION 0234512Bard Peripheral Vascular, Inc. · Balloon aortic valvuloplasty1 death10 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.
How reports and recalls are matched · Editorial policy · Report an error on this page