X-SUIT NIR BILIARY METALLIC STENT SME-200P-10060Recalls & reported problems
Medinol Ltd. · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04953170270659), received between Dec 6, 2015 and Dec 27, 2017 — classified as 1 death, 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
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Insufficient Device Problem Information1
Patient problems
- Death1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 27, 2017Break; Break
THE STENT WAS BROKEN IN HALF AFTER IT WAS DEPLOYED AT THE LOWER MIDDLE BILE DUCT AND THE BROKEN STENT IN SIDE OF THE DUODENUM WAS FALLEN IN THE DUODENUM. THE CUSTOMER WAS DEPLOYED A NEW STENT INTO THE STENT WHICH REMAINED INTO THE BILE DUCT. THERE WAS NO INJURY TO THE PATIENT. THE CONDITION OF THE PATIENT IS OK.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7147244 ↗DeathDec 6, 2015Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
A STENT PLACEMENT WAS COMPLETED. AFTER THE PROCEDURE, THE PT BECAME ILL AND URGENT TREATMENT WAS PERFORMED. THE PT PASSED AWAY. THE PT HAD ONE (1) TO THREE (3) MONTHS TO LIVE AT THE TIME OF THE STENT PLACEMENT. THE DISEASE NAME IS UNK. THE INCIDENT HAPPENED IN (B)(6).
Patient problems: Death
MAUDE report 5284977 ↗
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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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