Tracer Metro G26862Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00827002268623), received between May 27, 2016 and Jun 23, 2025 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 23, 2025Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK TRACER METRO DIRECT WIRE GUIDE. IT WAS REPORTED THAT AFTER PLACEMENT OF THE WIRE GUIDE IN THE PANCREATIC DUCT, THE USER ATTEMPTED TO INSERT ANOTHER DEVICE FROM THE GUIDEWIRE END BUT FELT RESISTANCE. THE PHYSICIAN CONTINUED TO ATTEMPT TO INSERT, BUT THE GUIDEWIRE COATING NOTICED PEELED [WIRE GUIDE COATING DAMAGE], THEREFORE, THE PHYSICIAN DISCONTINUED TO USE THE WIRE GUIDE [LOSS OF WIRE GUIDE ACCESS]. THEY WERE REPLACED WITH ANOTHER MANUFACTURE'S DEVICES TO CONTINUE TO COMPLETE THE PROCEDURE. 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 22309275 ↗
• MalfunctionFeb 25, 2025Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK TRACER METRO DIRECT WIRE GUIDE. IT WAS REPORTED THAT THE WIRE GUIDE WAS PLACED IN THE PANCREATIC DUCT, BUT THE WIRE GUIDE BECAME UNABLE TO PASS MIDWAY. USE OF DEVICE WAS DISCONTINUED [LOSS OF WIRE GUIDE ACCESS], AND THE PROCEDURE WAS COMPLETED USING OTHER PRODUCTS. PER EVALUATION OF PRODUCT RETURN ON 4 FEB 2025, DAMAGE TO THE PROXIMAL WIRE GUIDE COATING WAS NOTED. 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 21462205 ↗
• MalfunctionSep 14, 2018Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK TRACER METRO DIRECT WIRE GUIDE. THE WIRE STARTED TO UNRAVEL AND COME OFF TOWARDS THE PROXIMAL END WHERE THE MARKINGS ARE [COATING DAMAGE]. THEY REMOVED THE WIRE AND USED ANOTHER DEVICE TO COMPLETE THE CASE SUCCESSFULLY. 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 7876552 ↗
• InjuryNov 3, 2017Detachment Of Device Component; Detachment Of Device Component

  THE FOLLOWING INFORMATION WAS PROVIDED TO COOK VIA MEDWATCH REPORT MW5072361: "GUIDEWIRE PASSED THROUGH THE SPHINCTEROTOME, DIFFICULT CANNULATION. [THE] WIRE WAS REMOVED FROM THE SPHINCTEROTOME AND IT WAS NOTED THAT THE WIRE WAS SHEARED. IT WAS NOTED ON FLUOROSCOPY THAT PART OF THE WIRE WAS PRESENT IN THE PATIENT. [THE USER] ATTEMPTED TO REMOVE THE WIRE UNSUCCESSFULLY. ANOTHER GUIDEWIRE WAS USED TO PERFORM THE PROCEDURE WITH A NEW SPHINCTEROTOME." PER THE RECEIVED MEDWATCH REPORT, STATES THAT A SERIOUS INJURY OCCURRED AND ADVERSE EVENT WAS CHECKED "Y". THERE WERE NO OTHER DETAILS INCLUDED ON THE MEDWATCH REPORT. MULTIPLE ATTEMPTS TO DETERMINE THE CUSTOMER OR OTHER DETAILS RELATED TO THIS EVENT WERE COMPLETED WITH NO RESULTS.

  Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7001253 ↗
• MalfunctionJan 13, 2017Peeled/Delaminated; Device-Device Incompatibility; Peeled/Delaminated; Device-Device Incompatibility

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) THE PHYSICIAN USED A COOK TRACER METRO DIRECT WIRE GUIDE (METII-21-480). AT THE BEGINNING OF THE CASE, THE DOCTOR CANNULATED WITH ANOTHER MANUFACTURERS CANNULA [RECOMMENDED WIRE GUIDE DIAMETER TO BE USED WITH THIS CANNULA IS .018 IN]. THE ASSISTANT ADVANCED THE METII-21-480 [.021 IN] THROUGH THE PROXIMAL END OF THE CATHETER. THE ASSISTANT COULD FEEL THE WIRE STICKING A LITTLE BIT. WHEN SHE REMOVED THE WIRE GUIDE SHE COULD SEE THE COATING OF THE WIRE WAS SEPARATING FROM THE WIRE AND THE TIP. THEY REMOVED IT COMPLETELY AND GOT A NEW METII-21-480 AND THE REST OF THE CASE WENT FINE AND WAS FINISHED SUCCESSFULLY WITH THE SECOND WIRE GUIDE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6249382 ↗
• MalfunctionNov 17, 2016Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK TRACER METRO DIRECT WIRE GUIDE. THE PHYSICIAN WAS USING THE WIRE GUIDE IN THE SMALL INTESTINE NEAR THE BILE DUCT. THE COATING OF THE WIRE GUIDE SHREDDED OFF WHEN HE WAS PULLING THE WIRE GUIDE BACK INTO THE ENDOSCOPE. SOME OF THE COATING STAYED IN THE PATIENT'S SMALL INTESTINE. THE PHYSICIAN SAID IT WAS NOT HARMFUL AND WILL COME OUT IN THE PATIENT'S STOOL.

  Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 6109135 ↗
• MalfunctionMay 27, 2016Peeled/Delaminated; Peeled/Delaminated

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK TRACER METRO DIRECT WIRE GUIDE. THE "WIRE COATING WAS PEELING BACK."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5684877 ↗