Cook G00650Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00827002006508), received between Jun 23, 2017 and Jul 10, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Aug 16, 2022Open, Classified

   Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.

   Z-1834-2022 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2026Device Contaminated During Manufacture or Shipping

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25786656 ↗
• MalfunctionSep 26, 2018Stretched; Detachment of Device or Device Component

  THE COMPLAINANT REPORTED THAT THE STRAIGHT FIXED CORE WIRE GUIDE WAS DAMAGED, AND IT WAS REMOVED FROM THE PATIENT WITHOUT INCIDENT. IT WAS FURTHER NOTED THAT THE DISTAL WELD CONNECTION SEPARATED FROM THE COIL AND SAFETY WIRE WHICH RESULTED IN COIL ELONGATION. THE INNER MANDRIL AND SAFETY WIRE WERE ALSO NOTED TO BE EXPOSED. THE PRODUCT PROBLEMS DID NOT RESULT IN ANY REPORTED SERIOUS INJURIES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7909804 ↗
• MalfunctionSep 19, 2018Break

  THE COMPLAINANT REPORTED THAT THE STRAIGHT FIXED CORE WIRE GUIDE WAS USED FOR INSERTION OF A URETHRAL CATHETER WITH A FLEXIBLE CYSTOSCOPE. WHEN REMOVING THE WIRE GUIDE AFTER INTRODUCING THE CATHETER, IT WAS NOTED THAT A SECTION OF THE WIRE GUIDE HAD UNCOILED AND AN INNER SECTION OF THE WIRE GUIDE HAD SNAPPED. THERE WAS NO REPORT OF RESISTANCE DURING REMOVAL OR KINKING OF THE WIRE. THE PRODUCT PROBLEM DID NOT RESULT IN ANY REPORTED SERIOUS INJURIES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7889095 ↗
• MalfunctionSep 18, 2018Crack; Material Protrusion/Extrusion; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE STRAIGHT FIXED CORE WIRE GUIDE WAS STRIPPED, AND THERE WAS A CRACK IN THE COATING WITH THE INNER WIRE PROTRUDING. THIS WIRE DID NOT MAKE PATIENT CONTACT, SO THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 7887025 ↗
• MalfunctionJun 23, 2017Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, USING A STRAIGHT FIXED CORE WIRE GUIDE, THE GUIDE WIRE TORE APART. ADDITIONALLY, IT WAS REPORTED THAT THERE WAS NO CLINICAL SIGNIFICANCE/NO KNOWN INJURY OR IMPACT ON THE PATIENT DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6665552 ↗