Flexima™ M001271660Recalls & reported problems
Boston Scientific Corporation · Biliary Catheter System Kit · Class 2 · Implant
All models of Flexima (20)
Data updated Oct 16, 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 08714729323280), received between Sep 8, 2020 and Sep 8, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Unsealed Device Packaging” (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 16, 2026.
Most reported problems
Device problems
- Unsealed Device Packaging1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 8, 2020Unsealed Device Packaging; Unsealed Device Packaging
IT WAS REPORTED THAT THE PACKAGE WAS CONTAMINATED. A FLEXIMA DRAINAGE CATHETER WAS SELECTED FOR USE. DURING UNPACKING, IT WAS NOTED THAT THE INTERNAL AND EXTERNAL PACKAGE WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement
MAUDE report 10502578 ↗
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- Hurricane™ RX M00545940Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC2 recalls109 reports
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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