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Neff G04593Recalls & reported problems

Cook Incorporated · Neff Percutaneous Access Set · 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 00827002045934), received between May 24, 2017 and May 24, 2017 — 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. How this data works · Data updated Oct 13, 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.

  • InjuryMay 24, 2017Break; Break

    CUSTOMER REPORTED THAT A PATIENT WAS UNDERGOING A PERCUTANEOUS NEPHROSTOMY PROCEDURE ON (B)(6) 2017 USING A NEFF PERCUTANEOUS ACCESS SET. THE PHYSICIAN PLACED THE WIRE THROUGH THE DILATOR INTO THE RENAL PELVIS. THE WIRE REPORTEDLY "TURNED ON ITSELF AND PUT ITSELF IN A KNOT." ATTEMPTS WERE MADE TO STRAIGHTEN AND PULL THE TIP. THE WIRE SHEARED OFF WHILE STILL WITHIN THE RENAL PELVIS. THE SHEARED OFF PORTION OF THE WIRE WAS RETRIEVED USING A SNARE AND BIOPSY CLAMP. NO UNINTENDED SECTIONS OF THE DEVICE REMAINED WITHIN THE PATIENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. THE DEVICE WAS RECEIVED FOR EVALUATION.

    Patient problems: No Code Available

    MAUDE report 6587111 ↗

Other ACCESSORIES, CATHETER devices

All ACCESSORIES, CATHETER devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.