vanSonnenberg™ Sump M001273040Recalls & reported problems
Boston Scientific Corporation · Sump Catheter System · Class 2 · Implant
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 08714729138129), received between Dec 12, 2019 and Dec 12, 2019 — classified as 1 injury.
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 16, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 12, 2019Break; Break
IT WAS REPORTED THAT THE CATHETER SHAFT SEPARATED. A VANSONNENBERG SUMP DRAINAGE CATHETER WAS SELECTED FOR USE. ON (B)(6) 2019 THE CATHETER WAS INSTALLED INSIDE THE BODY OF THE PATIENT. A MALFUNCTION WAS THEN NOTED ON THE CATHETER AFTER INSTALLATION. THE CATHETER SHAFT HAD SEPARATED WHICH PREVENTED THE DEVICE FROM FUNCTIONING. SURGICAL INTERVENTION WAS REQUIRED TO REMOVE AND REPLACE THE DEVICE. ON (B)(6) 2019 A PROCEDURE WAS PERFORMED TO REPLACE THE DEVICE WITH A NEW DEVICE. THERE WERE NO REPORTED PATIENT CONSEQUENCES AND THE PATIENT STATUS WAS GOOD.
Patient problems: No Code Available
MAUDE report 9459946 ↗
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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