Cook G14899Recalls & reported problems
Cook Incorporated · Percutaneous Pigtail Nephrostomy Set · Class 2
Data updated Oct 13, 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 00827002148994), received between Jul 28, 2017 and Jul 28, 2017 — 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.
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- Device Embedded In Tissue or Plaque1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 28, 2017Detachment of Device or Device Component; Detachment of Device or Device Component
INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT WAS UNDERGOING PLACEMENT OF A PERCUTANEOUS PIGTAIL NEPHROSTOMY SET. THE GUIDE WIRE BROKE DURING THE PLACEMENT PROCEDURE. THE BROKEN FRAGMENT REMAINED IN THE KIDNEY. THE FRAGMENT WAS THEN RETRIEVED BY AN UNSPECIFIED METHOD DURING THE INITIAL PROCEDURE. NO ADDITIONAL SURGICAL PROCEDURES WERE PERFORMED. NO FRAGMENT REMAINS WITHIN THE PATIENTS' BODY. THE HANDLING CONDITIONS AND CIRCUMSTANCES SURROUNDING THE EVENT ARE NOT KNOWN. THE DEVICE IS NOT AVAILABLE FOR EVALUATION.
Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient
MAUDE report 6749734 ↗
Other CATHETER, SUPRAPUBIC (AND ACCESSORIES) devices
- Rutner G14920Cook Incorporated · CATHETER, SUPRAPUBIC (AND ACCESSORIES)5 reports
- Cook G26666Cook Incorporated · CATHETER, SUPRAPUBIC (AND ACCESSORIES)4 reports
- Rutner G15261Cook Incorporated · CATHETER, SUPRAPUBIC (AND ACCESSORIES)4 reports
- Cook G26655Cook Incorporated · CATHETER, SUPRAPUBIC (AND ACCESSORIES)1 report
- Cook G14095Cook Incorporated · CATHETER, SUPRAPUBIC (AND ACCESSORIES)1 report
- Ultrathane G30401Cook Incorporated · CATHETER, SUPRAPUBIC (AND ACCESSORIES)1 report
- Malecot G16922Cook Incorporated · CATHETER, SUPRAPUBIC (AND ACCESSORIES)1 report
- Malecot G16923Cook Incorporated · CATHETER, SUPRAPUBIC (AND ACCESSORIES)1 report
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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