Z-MED II X™ 618733Recalls & reported problems
B Braun Interventional Systems, Inc · Z-MED II-X 18X4X10X8X100X.035 PDZ733 · 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 04046964315848), received between Nov 21, 2017 and Nov 21, 2017 — 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. 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
- No Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 21, 2017Material Rupture
MEDWATCH FORM RECEIVED BY BIS FROM FDA - "DURING BALLOON AORTIC VALVULOPLASTY, THE BALLOON INITIALLY INFLATED BUT RUPTURED. AS A RESULT, THIS BALLOON WAS REMOVED AND ANOTHER BALLOON WAS INFLATED SUCCESSFULLY."
Patient problems: No Information
MAUDE report 7048034 ↗
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- WATCHMAN™ TruSeal™ Access System M635TU70020Boston Scientific Corporation · Catheter, percutaneous1 recall11 deaths217 reports
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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