Cook G03415Recalls & reported problems
Cook Incorporated · Percutaneous Nephrostomy Set · Class U
- 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 00827002034150), received between Jul 13, 2016 and Jul 13, 2016 — 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
- No Consequences Or Impact 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 13, 2016Break; Break
IT WAS REPORTED THE GUIDE WIRE BROKE INSIDE THE PATIENT AT THE LEVEL OF THE "BELL" (BEND). THE TIP FRAGMENT WAS SUCCESSFULLY REMOVED. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 5790087 ↗
Other CATHETER, NEPHROSTOMY devices
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- Dawson Mueller G11020Cook Incorporated · CATHETER, NEPHROSTOMY100 reports
- Cook G09502Cook Incorporated · CATHETER, NEPHROSTOMY86 reports
- NephroMax Kit M0062101180Boston Scientific Corporation · CATHETER, NEPHROSTOMY1 recall25 reports
- NephroMax Kit M0062101600Boston Scientific Corporation · CATHETER, NEPHROSTOMY1 recall11 reports
- Dawson Mueller G13768Cook Incorporated · CATHETER, NEPHROSTOMY59 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.