Stealth Malleable Occlusion Device A0L75Recalls & reported problems
Applied Medical Resources Corporation · Malleable Occlusion Device · 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 00607915110550), received between Aug 2, 2016 and Aug 2, 2016 — classified as 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 18, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 2, 2016Break; Break
PROCEDURE PERFORMED: N/A- "WE OPENED A MALLEABLE JAW ASSEMBLY A0L75. THE SURGEON BENT IT TO ADJUST THE ANGLE BEFORE APPLYING IT, AND A SMALL PLASTIC RING BROKE OFF. LUCKILY WE BELIEVE WE FOUND ALL THE PIECES. THE RING WAS LOCATED AT THE JOIN OF THE MALLEABLE SHAFT TO THE JAW ASSEMBLY. THE CLAMP WAS UNABLE TO BE USED AFTER THIS AS IT WAS COMPLETELY MALLEABLE. COULDN'T MAKE IT RIGID." PATIENT STATUS: "FINE".
Patient problems: No Consequences Or Impact To Patient
MAUDE report 5842112 ↗
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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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