Flexima™ APDL M001281340Recalls & reported problems
Boston Scientific Corporation · Drainage Catheter System with Dissolving Tip · Class 2 · Implant
All models of Flexima APDL (12)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729191780), received between Mar 18, 2021 and Mar 18, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Collapse” (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
- Collapse1
- Detachment of Device or Device Component1
- Difficult to Advance1
Patient problems
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 18, 2021Collapse; Detachment of Device or Device Component; Difficult to Advance; Collapse; Detachment of Device or Device Component; Difficult to Advance
IT WAS REPORTED THAT THE TIP DETACHMENT AND RETRIEVED DEVICE COMPONENT OCCURRED. THE DRAINAGE CATHETER WAS ATTACHED TO THE PATIENT'S KIDNEYS. A 8/25 FLEXIMA APDL WAS SELECTED FOR USE. THE FLEXIMA APDL CATHETER WAS ADVANCED OVER THE WIRE. THE CATHETER WAS MEETING RESISTANCE IN THE RETROPERITONEAL SOFT TISSUES AND THE TIP WAS TELESCOPING. THE PHYSICIAN PULLED THE CATHETER BACK AND NOTICED THAT THE CLEAR TAPERED PIECE AT THE TIP WAS MISSING. THIS PIECE WAS SEEN ON THE CATHETER WHILE IT WAS LOADED ON THE WIRE. IT WAS CONCLUDED THAT THE PIECE SOMEHOW DETACHED FROM THE CATHETER INSIDE THE PATIENT. THE DETACHED CATHETER TIP COULD NOT BE LOCATED WITHIN THE PATIENT. CONSEQUENTLY, THE PHYSICIAN DISSECTED THE SOFT TISSUES IN ATTEMPT TO LOCATED THE DETACHED TIP. LOCATING THE DETACHED TIP WAS UNSUCCESSFUL. IT WAS NOTED THAT THE DETACHED CATHETER TIP WAS STILL ON THE WIRE ABOUT 4-5 CM DEEP TO THE SKIN AND THE PHYSICIAN BELIEVES THIS LIKELY PUSHED THE PART THROUGH THE KIDNEY AND INTO THE COLLECTING SYSTEM. THE PROCEDURE WAS COMPLETED WITH A NON BOSTON SCIENTIFIC DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 11517099 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page