Tracer Hybrid G22659Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002226593), received between Mar 21, 2016 and Dec 12, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (3 reports).

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 18, 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 12, 2018Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK TRACER HYBRID WIRE GUIDE. THE COATING STRIPPED OFF OF THE TIP OF THE DEVICE. IT DID NOT DETACH AND WAS REMOVED WITH THE REST OF THE DEVICE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER MANUFACTURER'S WIRE GUIDE. ADDITIONAL INFORMATION WAS RECEIVED ON 26-NOV-2018: THE DAMAGE IS AT THE TIP OF THE DEVICE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8156619 ↗
• MalfunctionJun 2, 2017Detachment Of Device Component; Peeled/Delaminated; Improper or Incorrect Procedure or Method; Detachment Of Device Component; Peeled/Delaminated; Improper or Incorrect Procedure or Method

  IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK TRACER HYBRID WIRE GUIDE. AS THE USER WAS TAKING THE DEVICE OUT OF THE PACKAGE, THE TIP OF THE WIRE GUIDE STRIPPED AND UNRAVELED. ANOTHER DEVICE WAS ON HAND TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6608488 ↗
• MalfunctionMar 21, 2016Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK TRACER HYBRID WIRE GUIDE. THE WIRE GUIDE IS STUCK INSIDE OF THE BALLOON CATHETER AND RIPPED OFF THE MAIN WIRE [CORE WIRE]. THE WIRE GUIDE STRIPPED AT THE DISTAL END. A PIECE OF PLASTIC COVER [COATING] BROKE OFF AND ENDED UP IN THE CATHETER, THE PIECE WAS RETRIEVED. ITS UNKNOWN AT WHAT POINT THIS OCCURRED. THE CUSTOMER CONFIRMED THE ELEVATOR WAS DOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5514083 ↗