Cook G01402Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002014022), received between Nov 16, 2017 and Dec 14, 2018 — classified as 3 malfunctions.

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.

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.

• MalfunctionDec 14, 2018Crack; Component Missing; Failure to Advance

  THE COMPLAINANT REPORTED THAT THE TIP OF THE DILATOR WAS DAMAGED DURING THE PHYSICIAN'S ATTEMPT TO ADVANCE IT OVER THE WIRE GUIDE. AS A RESULT, ANOTHER DEVICE (UNKNOWN LOT NUMBER) OF THE SAME KIND WAS USED TO COMPLETE THE PROCEDURE. IT WAS FURTHER NOTED THAT THERE WAS A CRACK IN THE TIP OF THE DILATOR, AND A PIECE OF THE DILATOR TIP WAS MISSING. THE COMPLAINANT REPORTED THAT THE MISSING TIP WAS NOT IN THE PATIENT'S BODY. ADDITIONALLY, THE PRODUCT PROBLEM DID NOT RESULT IN ANY REPORTED SERIOUS INJURIES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8166482 ↗
• MalfunctionDec 14, 2018Break

  THE COMPLAINANT REPORTED THAT THE TIP OF THE DILATOR WAS DAMAGED DURING THE PHYSICIAN'S ATTEMPT TO ADVANCE IT OVER THE WIRE GUIDE. AS A RESULT, ANOTHER DEVICE OF THE SAME KIND WAS USED TO COMPLETE THE PROCEDURE. IT WAS FURTHER NOTED THAT THERE WAS A CRACK IN THE TIP OF THE DILATOR. THE PRODUCT PROBLEM DID NOT RESULT IN ANY REPORTED SERIOUS INJURIES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8166395 ↗
• MalfunctionNov 16, 2017Split; Material Deformation; Split; Material Deformation

  THE INTERNATIONAL CUSTOMER REPORTED THAT, WHEN THE DILATOR WAS ADVANCED OVER A WIRE GUIDE OF UNKNOWN MANUFACTURE, THERE WAS AN UNUSUAL FEELING FEEDBACK WAS FELT. WHEN THE OPERATOR CHECKED THE TIP OF THE DILATOR, A DEFORMATION/SPLIT WAS EVIDENT IN THE TIP OF THE DEVICE. ANOTHER DEVICE WAS USED INSTEAD TO COMPLETE THE PROCEDURE SUCCESSFULLY, WITH NO FURTHER ISSUES AND NO PATIENT ADVERSE EVENTS. THE DEVICE HAS BEEN RETURNED FOR EVALUATION; HOWEVER, AS OF THE DATE OF THIS REPORT, THE INVESTIGATION IS STILL PENDING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7039540 ↗