X-SUIT NIR BILIARY METALLIC STENT SME-200P-08080Recalls & reported problems
Medinol Ltd. · Class 2 · Implant
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 04953170270703), received between Jun 10, 2019 and Jun 10, 2019 — 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.
MalfunctionJun 10, 2019Break; Break
ACCORDING TO THE INITIAL CASE REPORT FORM RECEIVED ON MAY 16, 2019: THIS COMPLAINT WAS INITIATED USING INTERIM MODEL NAME (UNCOVERED TYPE) SINCE THE PRODUCT NAME IS UNKNOWN. THE EVENT HAPPENED OUT OF US IN THE RADIOGRAPHY, THE CUSTOMER FOUND THAT THE STENT OF X-SUIT NIR WAS BROKEN. NO ADDITIONAL INFORMATION ABOUT THE COMPLAINT IS AVAILABLE AT THIS TIME. THERE WASN'T ANY INJURY TO PATIENT. THE CONDITION OF THE PATIENT IS OK.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8682162 ↗
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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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