Z-MED™ 610470Recalls & reported problems
B Braun Interventional Systems, Inc · PDZ320 Z-MED 20X4X100 · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04046964329012), received between Feb 8, 2018 and Nov 30, 2022 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
- Device Operates Differently Than Expected1
- Material Rupture1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Code Available1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 30, 2022Break; Break
AS REPORTED FROM THE USER FACILITY / DISTRIBUTOR - BALLOON BURST WITH INFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15887515 ↗InjuryFeb 8, 2018Material Rupture; Material Separation; Device Operates Differently Than Expected
AS REPORTED TO NUMED - "REPORTING A MALFUNCTIONING ANGIOPLASTY BALLOON. THE BALLOON SEPARATED OFF OF THE SHAFT OF THE DELIVERY SYSTEM. THE PATIENT THEN HAD TO ENDURE ANOTHER PROCEDURE AND RISK AND TIME." ADDITIONAL INFORMATION RECEIVED ON 1/19/2018 - "THE BALLOON WAS COMPLETELY SEPARATED FROM THE SHAFT. IT WAS IN TWO SEPARATE PIECES WHEN IT CAME BACK OUT. THE BALLOON WAS ALSO RUPTURED AND THEY HAD TO SNARE OUT WHAT WAS LEFT BEHIND BEFORE USING A LARGER ATLAS GOLD 22 X 4 BALLOON TO FINISH THE PROCEDURE. THEY WERE UNAWARE OF THE RUPTURE AND DETACHMENT UNTIL THEY PULLED OUT THE BALLOON AND SAW IT. THERE WAS NO VIDEO. A 260 CM COOK LUNDERQUIST GUIDEWIRE WAS USED. THE Z-MED WAS INSIDE A STENT IN THE IVC. A 12FR 13 CM COOK FLEXOR SHEATH WAS USED. AN INFLATION DEVICE WITH PRESSURE GAUGE WAS USED. THE BALLOON RUPTURED CIRCUMFERENTIALLY, HOWEVER IT WAS NOT DURING INFLATION OR DEFLATION. THE CATHETER SHAFT WAS NOT KINKED. THERE WAS NOTHING UNUSUAL ABOUT THE PATIENT ANATOMY. THE PATIENT WAS FINE POST PROCEDURE." ADDITIONAL INFORMATION RECEIVED ON 2/5/2018 - " THE Z-MED WAS USED TO DILATE A PREVIOUSLY PLACED STENT IN THE IVC. THEY INFLATED THE BALLOON AND DEFLATED THE BALLOON WITHOUT PROBLEM.
Patient problems: No Code Available
MAUDE report 7251833 ↗
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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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