Tracer Metro G25686Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00827002256866), received between Sep 24, 2018 and Sep 2, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50555690 ↗
• MalfunctionMay 8, 2025Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC STONE REMOVAL FROM CBD PROCEDURE, THE PHYSICIAN USED A COOK TRACER METRO DIRECT WIRE GUIDE. IT WAS REPORTED THAT THE [WIRE GUIDE] TIP BENT AND OUTER COATING PEELED OFF. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 21987851 ↗
• MalfunctionApr 12, 2019Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK TRACER METRO DIRECT WIRE GUIDE. THE FOLLOWING INFORMATION WAS PROVIDED TO COOK VIA MEDWATCH REPORT (B)(4): "WIRE GOT STUCK IN A RETRIEVAL BALLOON, AND DID NOT FUNCTION PROPERLY. THE COATING OF THE WIRE SHEARED OFF AND GOT CAUGHT." OUR ATTEMPTS TO COLLECT ADDITIONAL INFORMATION REGARDING PATIENT OUTCOME WERE UNSUCCESSFUL. WHILE THE COMPLAINANT DID NOT SPECIFY IF THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS OR REQUIRED ADDITIONAL MEDICAL PROCEDURES DUE TO THIS EVENT, THE INFORMATION ABLE TO BE COLLECTED DOES NOT REASONABLY SUGGEST THE PATIENT WAS ADVERSELY IMPACTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8510343 ↗
• MalfunctionNov 21, 2018Peeled/Delaminated; Positioning Problem; Migration; Peeled/Delaminated; Positioning Problem; Migration

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK TRACER METRO DIRECT WIRE GUIDE. THE COATING OF THE WIRE GOT DAMAGED. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2018, THE WIRE GUIDE WAS PLACED OVER A CATHETER/SPHINCTEROTOME AND LEFT IN THE BILE DUCT. A METAL STENT WAS ADVANCED OVER THE WIRE GUIDE, BUT COULD NOT BE ADVANCED FULLY AS IT GOT STUCK. EVERYTHING WAS REMOVED [LOST WIRE GUIDE ACCESS]. DAMAGE AND STRIPPING OF THE COATING OF THE WIRE GUIDE WAS VISIBLE. PLACEMENT OF A NEW WIRE GUIDE AND FINISHED PROCEDURE WITH THIS NEW 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 8095057 ↗
• MalfunctionSep 24, 2018Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK TRACER METRO DIRECT WIRE GUIDE. THE PHYSICIAN WANTED TO CANNULATE BY USING ANOTHER MANUFACTURER'S DEVICE AND A METII-35-480. THE ASSISTANT NURSE OPENED THE PACKAGE OF THE MET II-35-480 AND FLUSHED. WHEN THE NURSE TRIED TO PUT THE WIRE IN THE PORT, A PORTION OF THE COATING TIP WAS DETACHED FROM THE GUIDE WIRE [PRIOR TO ENDOSCOPE CONTACT]. THE NURSE OPENED THE NEW ONE AND IT WAS USED. FURTHER INFORMATION WAS RECEIVED ON 09-SEPTEMBER- 2018: THE LOCATION OF THE DAMAGE OCCURRED AT THE PATIENT END, IN THE BLACK COATED TIP. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 7901527 ↗