Cook G00362Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002003620), received between Mar 3, 2016 and Sep 19, 2018 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Crack” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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-1831-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 19, 2018Material Frayed; Material Twisted/Bent

  IT WAS REPORTED THAT THE FLEXIBLE TIPPED WIRES HAD A TENDENCY TO BEND OR FRAY WHILE BEING INSERTED INTO THE PATIENT. THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES REPORTED. ADDITIONAL INFORMATION HAD BEEN REQUESTED BUT NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7891426 ↗
• MalfunctionNov 17, 2017Crack; Manufacturing, Packaging or Shipping Problem; Crack; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT UPON OPENING THE STRAIGHT AND CURVED DOUBLE FLEXIBLE TIPPED WIRE GUIDE ONTO THE PROCEDURE TROLLEY, IT WAS NOTICED THAT THE J TIP WAS MISSING. THE USER ATTEMPTED TO FASHION A J ON THE WIRE GUIDE; HOWEVER, THE WIRE DID NOT HANDLE AS ANTICIPATED AS THE OUTER LAYER CRACKED REVEALING A SHARP METAL FROM THE INNER LAYER. THE WIRE GUIDE WAS DISCARDED AND DID NOT COME INTO CONTACT WITH A PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7043101 ↗
• InjuryMar 3, 2016Difficult to Remove; Unraveled Material; Difficult to Remove; Unraveled Material

  INITIAL INFORMATION STATED: WIRE SPLIT PARTIALLY MID-SHAFT DURING URETERIC STENT CASE. ADDITIONAL INFORMATION PROVIDED BY THE PHYSICIAN ON 08FEB2016 DETERMINED THE REPORTABILITY OF THE EVENT: DURING A URETERIC STENT PROCEDURE, THE WIRE SPLIT PARTIALLY MID-SHAFT DURING URETERIC STENT CASE. THE PHYSICIAN WAS PLANNING ON INSERTING A URETERIC STENT. A NEPHROSTOMY WAS ALREADY IN SITU. THE WIRE WAS PASSED INTO THE NEPHROSTOMY AND SEEN TO BE IN URETERIC SYSTEM. THE PHYSICIAN THEN REMOVED THE NEPHROSTOMY. HOWEVER, WHEN THE NEPHROSTOMY TUBE WAS AT THE LEVEL OF SKIN, IT BECAME APPARENT THAT THE WIRE SUTURE OF THE NEPHROSTOMY WAS CAUGHT ON SOMETHING. THE PHYSICIAN COULDN'T MANIPULATE IT FREE AND SO THE WIRE WAS CUT OFF THE NEPHROSTOMY AND PULLED THROUGH - NOT UNUSUAL PARTICULARLY. THE PHYSICIAN WAS THEN CONFRONTED WITH PROFUSE BLEEDING FROM THE SKIN. A 6FR BMC(UNKNOWN MANUFACTURER) WAS PASSED OVER THE WIRE AND INTO THE KIDNEY TO TAMPONADE THE BLEEDING WHICH DID NOT STOP. THE PHYSICIAN THEN ELECTED TO REPLACE A NEPHROSTOMY TUBE IN ORDER TO STOP THE BLEEDING AND ATTEMPTED TO PULL THE BMC (UNKNOWN MANUFACTURER) BACK, BUT IT PULLED THE WIRE WITH IT AND SO THE PHYSICIAN ATTEMPTED TO ADVANCE THE WI

  Patient problems: Blood Loss

  MAUDE report 5477737 ↗