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Z-MED II™ 611769Recalls & reported problems

B Braun Interventional Systems, Inc · PDZ669 ZMED II 25X4X100 · 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 04046964337734), received between Nov 9, 2018 and Nov 9, 2018 — classified as 1 injury.

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
  • Material Separation1

Patient problems

  • No Code Available1

Recent adverse event reports

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

  • InjuryNov 9, 2018Material Rupture; Material Separation

    AS REPORTED TO NUMED BY THE USER FACILITY AND THE DISTRIBUTOR (B)(4) - "BALLOON RUPTURED CIRCUMFERENTIALLY AT 4 ATM ON A CALCIUM SPICULE IN THE PULMONIC ANNULUS. UPON BALLOON RUPTURE, PHYSICIAN WITHDREW PROXIMAL PORTION OF BALLOON TOWARDS INTRODUCER SHEATH AND NOTED THAT THE DISTAL PORTION OF BALLOON CATHETER SHAFT AND BALLOON REMNANTS WERE NOT TRACKING PROPERLY OVER THE WIRE AND COULD NOT BE WITHDRAWN THOUGH THE 12F COOK SHEATH. PHYSICIAN NOTED THAT THE DISTAL REMNANTS HAD SEPARATED FROM THE PROXIMAL PORTION OF THE BALLOON CATHETER AND HAD TO BE SNARED VIA AN 18F SHEATH (ACCESS POINT LEFT FEMORAL). ALL COMPONENTS OF BALLOON ALONG WITH THE GUIDEWIRE WILL BE RETURNED FOR EVALUATION/ANALYSIS. THE INDICATION THE PHYSICIAN WAS USING THE BALLOON FOR: PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY (PTV). AN INFLATION DEVICE WITH PRESSURE GAUGE WAS USED. THE SIZE AND TYPE OF INTRODUCER SHEATH USED: 12F X 13CM COOK CHECK-FLO INTRODUCER SET. THE CATHETER SHAFT WAS NOT KINKED. AN ATLAS GOLD 22X4X120 WAS USED TO COMPLETE THE PROCEDURE. BALLOON RUPTURED CIRCUMFERENTIALLY AT 4 ATM. BALLOON DISTAL REMNANTS SEPARATED FROM THE PROXIMAL PORTION OF THE BALLOON CATHETER AND HAD TO BE SNARED."

    Patient problems: No Code Available

    MAUDE report 8056246 ↗

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Sources and updates

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