Flexima™ APD™ M001271280Recalls & reported problems
Boston Scientific Corporation · Drainage Catheter System · Class 2
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 08714729323051), received between Mar 31, 2022 and Mar 31, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Remove” (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
- Difficult to Remove1
- Material Deformation1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 31, 2022Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation
IT WAS REPORTED THAT THE DRAIN WAS DIFFICULT TO REMOVE. A 6F FLEXIMA APD DRAINAGE CATHETER SYSTEM WAS SELECTED FOR USE IN A PROCEDURE. DRAINAGE COULD NOT BE PERFORMED WITH THIS DEVICE. THE DRAIN HAD COILED AT THE DISTAL END OF THE DRAIN INTO THREE SPIRALS. THIS COILING MADE WITHDRAWAL DIFFICULT, WHICH POSSIBLY CAUSED BLEEDING. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 13971325 ↗
Other TUBE, DRAINAGE, SUPRAPUBIC devices
- Flexima™ APDL M001271380Boston Scientific Corporation · TUBE, DRAINAGE, SUPRAPUBIC17 reports
- Flexima™ APDL M001271340Boston Scientific Corporation · TUBE, DRAINAGE, SUPRAPUBIC2 deaths16 reports
- Flexima™ APDL M001271960Boston Scientific Corporation · TUBE, DRAINAGE, SUPRAPUBIC1 death10 reports
- Flexima™ APDL M001271350Boston Scientific Corporation · TUBE, DRAINAGE, SUPRAPUBIC9 reports
- Flexima™ APD™ M001271360Boston Scientific Corporation · TUBE, DRAINAGE, SUPRAPUBIC8 reports
- Flexima™ APDL M001271330Boston Scientific Corporation · TUBE, DRAINAGE, SUPRAPUBIC6 reports
- Flexima™ APDL M001275010Boston Scientific Corporation · TUBE, DRAINAGE, SUPRAPUBIC3 reports
- Flexima™ APDL M001275030Boston Scientific Corporation · TUBE, DRAINAGE, SUPRAPUBIC3 reports
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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