Z-MED II X™ 618716Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046964315497), received between Aug 16, 2021 and Aug 16, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Difficult to Remove” (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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 16, 2021Off-Label Use; Difficult to Remove; Off-Label Use; Difficult to Remove

  THE BALLOON WOULD NOT ENTER THE SHEATH POST INFLATION. BALLOON WAS SURGICALLY REMOVED. THE BALLOON WAS BEING USED FOR ATRIAL SEPTUM BALLOONING. AN INFLATION DEVICE WITH PRESSURE GAUGE WAS USED. A COOK FLEXOR 10FR INTRODUCER SHEATH WAS USED. THE CATHETER SHAFT WAS NOT KINKED. THERE WAS NOTHING UNUSUAL ABOUT THE PATIENT ANATOMY. (B)(6) 2021 - IN AN EMAIL FROM THE ACCOUNT - ITEMS USED WITH THE BALLOON: .035 SUPERSTIFF WIRE, .035 J WIRE, 10FR FLEXOR COOK, 12FR FLEXOR SHEATH, 16FR COOK SHEATH.

  Patient problems: Insufficient Information

  MAUDE report 12328175 ↗