Flexima™ M001271810Recalls & reported problems
Boston Scientific Corporation · Nephrostomy Catheter System · Class 1
- 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 08714729323327), received between Dec 10, 2025 and Dec 10, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT HUB DETACHMENT OCCURRED. A FLEXIMA WAS SELECTED FOR USE. THE NEPHROSTOMY TUBE WAS PLACED ON (B)(6) 2025. FIFTEEN DAYS POST PROCEDURE, THE PATIENT RETURNED BECAUSE THE NEPHROSTOMY TUBE WAS SEPARATED FROM THE HUB. THE TUBE WAS REMOVED, AND IT WAS REPLACED WITH A NEW NEPHROSTOMY TUBE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT AND THE PATIENT FULLY RECOVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23767294 ↗
Other CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY devices
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- NA M0064201110Boston Scientific Corporation · CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY6 reports
- Skater™ All-Purpose and Nephrostomy Set 756608025Argon Medical Devices, Inc. · Catheter, Nephrostomy, General & Plastic Surgery5 reports
- Flexima™ M001271790Boston Scientific Corporation · CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY4 reports
- Re-Entry Malecot Nephrostomy Catheter Set M0064101060Boston Scientific Corporation · CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY4 reports
- SKATER™ All Purpose and Nephrostomy Drainage Set 756608035Argon Medical Devices, Inc. · Catheter, Nephrostomy, General & Plastic Surgery4 reports
- Flexima™ M001271860Boston Scientific Corporation · CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY2 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.