Cook G27257Recalls & reported problems
Cook Incorporated · Percutaneous Entry Thinwall Needle Catheter Access · Class 2
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 00827002272576), received between Oct 24, 2024 and Oct 24, 2024 — 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.
Reports received per month
Most reported problems
Device problems
- Break1
Patient problems
- Foreign Body In Patient1
- Unspecified Mental, Emotional or Behavioral Problem1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 24, 2024Break; Break
AS REPORTED, DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL), A CATHETER ACCESS PERCUTANEOUS ENTRY NEEDLE BROKE WHILE GAINING RENAL ACCESS. ATTEMPTS WERE MADE TO RETRIEVE THE SEPARATED PORTION OF THE DEVICE; HOWEVER, THE DECISION WAS MADE TO LEAVE THE REMAINING SIXTEEN CENTIMETERS OF THE CATHETER INSIDE THE PERINEPHRIC/SUBCUTANEOUS SPACE TO PREVENT FURTHER HARM TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Foreign Body In Patient; Unspecified Mental, Emotional or Behavioral Problem
MAUDE report 20521435 ↗
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- NA EP003994SMedtronic, Inc. · Trocar60 reports
- Cook G02364Cook Incorporated · Trocar1 recall5 reports
- HeartSpan® 00884450489345Merit Medical Systems, Inc. · Trocar1 recall1 death2 reports
- Cook G01377Cook Incorporated · Trocar1 recall2 reports
- Cook G02365Cook Incorporated · Trocar1 recall0 reports
- Endrys G19261Cook Incorporated · Trocar1 recall0 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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