Z-MED II X™ 618730Recalls & reported problems
B Braun Interventional Systems, Inc · Z-MED II-X 16X5X9X7X100X.035 PDZ730 · Class 2
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 04046964315787), received between Jul 15, 2022 and Jul 15, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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
- Improper or Incorrect Procedure or Method1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 15, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
AS PER THE REPORT FROM THE USER FACILITY / DISTRIBUTOR - POST PROCEDURE THE DEFLATED BALLOON WOULD NOT WITHDRAW INTO THE 9F CORDIS AVANTI SHEATH. DR TRIED TO REMOVE SHEATH AND BALLOON TOGETHER BUT FELT RESISTANCE AND STOPPED. VASCULAR SURGEON PERFORMED A FEMORAL CUT DOWN AND REMOVED THE SHEATH AND BALLOON. PATIENT WAS STABLE POST PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15029351 ↗
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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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