Cope G08427Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00827002084278), received between Jul 20, 2017 and Sep 18, 2025 — classified as 12 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Material Separation” (9 reports).

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. How this data works · Data updated Oct 13, 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-1829-2022 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2025Unraveled Material; Unraveled Material

  NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: Insufficient Information

  MAUDE report 23086399 ↗
• MalfunctionJan 13, 2025Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT A COPE NITINOL MANDRIL WIRE GUIDE UNRAVELED DURING ACCESS IN AN UNKNOWN PROCEDURE FOR AN UNKNOWN PATIENT. A NEW LIKE-DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. IT WAS CONFIRMED BY THE USER THAT THE WIRE GUIDE DID NOT SEPARATE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING EVENT DETAILS HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21143386 ↗
• InjuryJul 28, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A FEMALE PATIENT REQUIRED A COPE NITINOL MANDRIL WIRE GUIDE DURING A PROCEDURE TO TREAT PERIPHERAL ARTERIAL DISEASE IN A SUPERFICIAL FEMORAL ARTERY. THE WIRE WAS INSERTED, WITHOUT RESISTANCE, THROUGH THE GROIN UTILIZING A 5 FR MICROPUNCTURE SET. THE WIRE LOOPED OUTSIDE OF THE MICROPUNCTURE SHEATH WITHIN THE PATIENT. THE PHYSICIAN PULLED THE WIRE BACK TO STRAIGHTEN IT, AND THE WIRE BROKE IN HALF, LEAVING HALF OF THE WIRE REMAINING INSIDE THE PATIENT. THE WIRE FRAGMENT WAS SUCCESSFULLY RETRIEVED WITH A 10 MM GOOSE NECK SNARE. ACCESS WAS REGAINED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW 5 FR MICROPUNCTURE SET AND WIRE FROM ANOTHER MANUFACTURER. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT. ADDITIONAL INFORMATION REGARDING EVENT DETAILS HAS BEEN REQUESTED, BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 15124525 ↗
• InjuryNov 15, 2021Material Separation; Material Separation

  IN ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2021, IT WAS REPORTED THAT THE PATIENT DID NOT HAVE TORTUOUS, CALCIFIED OR SCARRED ANATOMY. THE ACCESS SITE WAS RIGHT BELOW THE PATIENT'S GROIN CREASE. THE WIRE WAS NOT ALTERED PRIOR TO USE. RESISTANCE WAS EXPERIENCED DURING INSERTION. THE FIRST ATTEMPT TO REMOVED THE WIRE WAS THROUGH A NEEDLE, THEN THE NEEDLE WAS REMOVED AND THEN "TRIED TO REMOVE RIGHT FROM THE SKIN." THE FLOPPY TIP OF THE WIRE WAS UNABLE TO BE REMOVED FROM THE PATIENT. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A DELAY, AS ADDITIONAL TIME WAS SPENT TRYING TO RETRIEVE THE BROKEN PIECE, AS WELL AS AN ADDITIONAL SKIN INCISION WITH A SCALPEL. NO ADDITIONAL HARM TO THE PATIENT HAS BEEN REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12810656 ↗
• InjuryAug 10, 2021Material Separation; Material Separation

  IN ADDITIONAL INFORMATION PROVIDED ON 29SEP2021, IT WAS REPORTED THAT THE PATIENT DID NOT HAVE TORTUOUS ANATOMY. IT WAS NOTED THAT THE WIRE GUIDE WAS NOT MANIPULATED THROUGH A NEEDLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 12299809 ↗
• InjuryMar 4, 2021Material Separation; Material Separation

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 11413644 ↗
• MalfunctionFeb 24, 2021Unraveled Material; Unraveled Material

  IN ADDITIONAL INFORMATION RECEIVED ON 02MAR2021, IT WAS REPORTED THAT THE DEVICE UNRAVELED AS IT WAS PASSED THROUGH THE IV CATHETER, WHICH HAD A FITTED DIAMETER FOR THE DEVICE. NO ISSUES WERE EXPERIENCED DURING INSERTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11373106 ↗
• MalfunctionDec 10, 2020Unraveled Material; Unraveled Material

  IT WAS REPORTED AN UNKNOWN PATIENT REQUIRED A COPE NITINOL MANDRIL WIRE GUIDE FOR A PICC LINE PLACEMENT PROCEDURE. THE OPERATOR PUNCTURED THE BASILIC VEIN WITH A 21 GAGE VASCULAR NEEDLE AND INSERTED THE WIRE GUIDE INTO THE NEEDLE. THE WIRE GUIDE WAS DIFFICULT TO ADVANCE AND THE OPERATOR MANIPULATED AND PULLED THE WIRE. THE WIRE GUIDE FRAYED WITHIN THE PUNCTURE NEEDLE. THE PATIENT HAD A HEMATOMA AND THE VEIN WAS DAMAGED AS A RESULT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER WIRE GUIDE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: Hematoma

  MAUDE report 10987950 ↗
• MalfunctionJul 30, 2020Material Separation; Material Twisted/Bent; Material Separation; Material Twisted/Bent

  ADDITIONAL INFORMATION PROVIDED 26 AUG 2020 STATED THE PROCEDURE WAS LOWER EXTREMITY VENOUS ACCESS. THE WIRE UNCOILED AND STRETCHED OUT AND THE PORTION REMAINING IN THE PATIENT LOOKED KNOTTED ON X-RAY. THE PROCEDURE WAS COMPLETED BY USING A DIFFERENT WIRE. A SURGEON IS TO BE CONSULTED REGARDING THE PORTION THAT IS LEFT IN THE PATIENT, BUT NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 10345370 ↗
• MalfunctionJun 24, 2019Break; Material Separation; Difficult to Advance; Break; Material Separation; Difficult to Advance

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 8728638 ↗
• InjuryApr 15, 2019Material Fragmentation; Material Fragmentation

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Code Available

  MAUDE report 8513518 ↗
• MalfunctionFeb 8, 2019Difficult to Remove; Unraveled Material; Difficult to Remove; Unraveled Material

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8320101 ↗
• MalfunctionJan 29, 2019Separation Failure; Separation Failure

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8286735 ↗
• InjuryNov 21, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT A COPE NITINOL MANDRIL WIRE GUIDE WAS USED DURING A VENOPLASTY PROCEDURE FOCUSED IN THE LEFT LEG OF THE PATIENT. IN AN ATTEMPT TO ACCESS THE GREAT SAPHENOUS VEIN WITH THE COOK MICROPUNCTURE SET, THE WIRE BENT ON INITIAL INSERTION. A NEW WIRE WAS THEN USED, BUT THERE WAS DIFFICULTY ADVANCING THE WIRE INTO THE VESSEL DUE TO POST THROMBOTIC DISEASE. THE WIRE WAS THEN PULLED BACK THROUGH THE NEEDLE AND RE-ADVANCED, IN WHICH DIFFICULTY WAS AGAIN OBSERVED. WHEN ATTEMPTING TO REMOVE THE WIRE AGAIN, THE TIP OF THE WIRE SEPARATED AND REMAINED IN THE PATIENT. THE PATIENT REQUIRED A CUTDOWN PROCEDURE TO RETRIEVE THE TIP OF THE WIRE. THE PHYSICIAN NOTED THAT ALTHOUGH THE WIRE SHOULD NOT HAVE SNAPPED, IT WAS BEING USED IN A VERY DISEASED VEIN WITH POST THROMBOTIC DISEASE, SO SCARRING AND THROMBUS MADE ACCESS VERY DIFFICULT. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 8095128 ↗
• InjuryNov 15, 2018Material Separation; Material Separation

  IT WAS REPORTED A COPE NITINOL MANDRIL WIRE GUIDE WAS USED FOR AN UNSPECIFIED PROCEDURE. DURING THE PROCEDURE, THE WIRE GUIDE BECAME STUCK IN THE CHIBA NEEDLE, FRAYED, AND THEN THE TIP OF THE WIRE SEPARATED. THE SEPARATED FRAGMENT OF THE WIRE GUIDE WIRE REMAINED IN THE URETER OF THE PATIENT. IT IS UNKNOWN IF ADDITIONAL PROCEDURES WERE SCHEDULED OR PERFORMED TO REMOVE THE SEPARATED FRAGMENT. ADDITIONAL INFORMATION REGARDING THE EVENT, PATIENT OUTCOME, AND ADDITIONAL PROCEDURES HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 8075401 ↗
• InjuryOct 30, 2018Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THE TIP OF A COPE NITINOL MANDRIL WIRE GUIDE SEPARATED DURING A NEPHROSTOMY INSERTION. THE SEPARATED FRAGMENT REMAINED IN THE PATIENT IN AN UNSPECIFIED LOCATION. IT IS UNKNOWN WHETHER THE FRAGMENT HAS BEEN REMOVED SUCCESSFULLY. ADDITIONAL DETAILS REGARDING THE EVENT AND PATIENT OUTCOME HAVE BEEN REQUESTED BUT ARE CURRENTLY UNAVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 8022151 ↗
• MalfunctionJul 20, 2018Material Separation; Material Separation

  IT WAS REPORTED A COPE NITINOL MANDRIL WIRE GUIDE WAS DIFFICULT TO INSERT INTO THE LIVER DURING A HEPATIC VEIN EMBOLIZATION. WHEN THE WIRE WAS REMOVED THERE WAS RESISTANCE, A FRAGMENT OF THE WIRE DETACHED AND WAS INSIDE THE LIVER. USING A SNARE, THE WIRE FRAGMENT WAS REMOVED AND NO PIECES OF THE DEVICE REMAINED WITHIN THE PATIENT. THE PROCEDURE CARRIED ON WITH THE USE OF ANOTHER WIRE. AS REPORTED BY THE FACILITY, THE HARD LIVER WAS LIKELY THE CAUSE OF THIS DEVICE ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7706911 ↗
• InjuryJul 16, 2018Break; Break

  THE USER FACILITY REPORT (B)(4) WAS RECEIVED ON 25-JUN-2018 REPORTING THE FOLLOWING. A PATIENT WITH HISTORY OF DUCHENE'S AND BILATERAL RENAL STONES, INCLUDING LEFT STAGHOR. PRIOR TO PATIENT GOING TO THE OR FOR A LEFT PERCUTANEOUS LITHOTOMY, PATIENT PRESENTED TO INTERVENTIONAL RADIOLOGY DEPARTMENT FOR PLACEMENT OF PERCUTANEOUS NEPHROSTOMY TUBE. DURING THE PROCEDURE, APPROXIMATELY 3.5 CM TO 4 CM OF THE 0.18 DIAMETER WIRE DETACHED AND REMAINS IN SITU. THE RADIOLOGIST FELT IT WOULD HAVE CAUSED MORE HARM TO THE PATIENT IF HE TRIED TO RETRIEVE THE FRAGMENT IN POSTERIOR FLANK MUSCLE. TO DATE, ADDITIONAL INFORMATION WITH REGARDS TO THE PATIENT AND EVENT HAVE BEEN REQUESTED BUT NOT PROVIDED. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 7692447 ↗
• MalfunctionMar 9, 2018Kinked; Kinked

  THE INTERNATIONAL CUSTOMER REPORTED THAT DURING THE PLACEMENT BY AN INTERN, THE COPE NITINOL MANDRIL WIRE GUIDE, INTO THE RIGHT ARM, IT WAS DISCOVERED THAT THE WIRE GUIDE KINKED 2 CM FROM THE EXTREMITY; THE GUIDE WIRE PERFORATED THE PATIENT'S VEIN. THE RADIOLOGIST REPORTEDLY HAD TO OPEN ANOTHER WIRE GUIDE TO CONTINUE THE PROCEDURE. THE WIRE HAD BEEN INSERTED THROUGH AND REMOVED FROM AN ACCESS NEEDLE. ADDITIONAL PROCEDURES WERE REPORTEDLY NOT REQUIRED AS A RESULT OF THE ISSUE. NO FURTHER INFORMATION COULD BE PROVIDED BY THE CUSTOMER. THE COMPLAINT DEVICE IS REPORTEDLY AVAILABLE FOR RETURN; HOWEVER, AS OF THE DATE OF THIS REPORT, NO DEVICE HAS YET BEEN RECEIVED FOR EVALUATION.

  Patient problems: Perforation

  MAUDE report 7327597 ↗
• MalfunctionDec 18, 2017Break; Use of Device Problem; Break; Use of Device Problem

  THE INTERNATIONAL CUSTOMER REPORTED THAT, AFTER THE COPE NITINOL MANDRIL WIRE GUIDE WAS INSERTED INTO THE BODY TO ACCESS THE TARGET AREA, THE PHYSICIAN ATTEMPTED TO REMOVE IT FROM THE PATIENT AND WAS NOT SUCCESSFUL. AFTER USING FORCE TO CONTINUE PULLING THE WIRE, IT BROKE. THE WIRE WAS THEN CHANGED OUT WITH A NEW PRODUCT OF THE SAME TYPE, AND THE REST OF THE PROCEDURE WAS COMPLETED WITHOUT ANY FURTHER COMPLICATIONS. THE PRODUCT IS REPORTEDLY AVAILABLE FOR RETURN; HOWEVER, AS OF THE DATE OF THIS REPORT, NO DEVICE HAS YET BEEN RECEIVED FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7126858 ↗
• InjuryDec 5, 2017Fracture; Fracture

  THE CUSTOMER REPORTED THAT THE COPE NITINOL MANDRIL WIRE GUIDE UNRAVELED AFTER ADVANCING THROUGH THE NEEDLE. THE PRODUCT PROBLEM REPORTEDLY OCCURRED WHEN THE OPERATOR WAS ATTEMPTING TO REMOVE THE WIRE. NO RESISTANCE OR KINKING OF THE WIRE WERE ENCOUNTERED, BUT ULTIMATELY PART OF THE WIRE BROKE OFF IN THE PATIENT'S LEFT SUBCLAVIAN AND WAS NOT RETRIEVED. THE CIRCUMSTANCES SURROUNDING THE USAGE AND HANDLING OF THE DEVICE LEADING UP TO THE DEVICE MALFUNCTION WERE NOT REPORTED. THE DEVICE IS REPORTEDLY UNAVAILABLE FOR RETURN.

  Patient problems: Foreign Body In Patient

  MAUDE report 7084272 ↗
• InjuryOct 23, 2017Material Frayed; Material Frayed

  THE CUSTOMER REPORTED THAT, WHILE TAKING THE COPE NITINOL MANDRIL WIRE GUIDE OUT OF THE ARTERY THROUGH THE NEEDLE, THE WIRE REPORTEDLY FRAYED AND CAME APART IN THE ARTERY. TO REMEDY THE SITUATION, THE OPERATOR REPORTEDLY PULLED THE NEEDLE AND THE WIRE OUT TOGETHER, AND RE-STUCK THE PATIENT TO FINISH THE PROCEDURE. THE CUSTOMER CONFIRMED THAT ALTHOUGH THE WIRE FRAYED, NO PART OF THE WIRE BROKE OFF INTO THE PATIENT AT ANY TIME. NO FURTHER COMPLICATIONS WERE REPORTED BY THE CUSTOMER. THE CIRCUMSTANCES SURROUNDING THE HANDLING AND USAGE OF THE DEVICE PRIOR TO THE REPORTED PRODUCT ISSUE WERE NOT REPORTED. THE DEVICE IS REPORTEDLY AVAILABLE FOR RETURN; HOWEVER, AS OF THE DATE OF THIS REPORT, THE DEVICE HAS NOT YET BEEN RECEIVED FOR EVALUATION.

  Patient problems: No Code Available

  MAUDE report 6968826 ↗
• InjuryJul 20, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  CUSTOMER REPORTED THAT A PATIENT WAS UNDERGOING AN UNSPECIFIED PROCEDURE USING A COPE NITINOL MANDRIL WIRE GUIDE. THE WIRE BROKE OFF WHILE IN THE PANCREATIC DUCT DURING THE PROCEDURE. THE ACTIONS TAKEN BY THE CLINICAL STAFF ARE NOT KNOWN. ADDITIONAL INFORMATION WAS REQUESTED; NO ADDITIONAL INFORMATION WAS RECEIVED AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION. ADDITIONAL INFORMATION: THE CUSTOMER REPORTED THAT THE WIRE FRACTURED WHILE THE OPERATOR WAS ATTEMPTING TO DILATE THE PANCREATIC DUCT OSTIUM. SUBSEQUENTLY, A PORTION OF THE WIRE WAS REMOVED ENDOSCOPICALLY, A PORTION WAS REMOVED PERCUTANEOUSLY, AND A SMALL PORTION WAS RETAINED. THIS RETAINED PORTION WAS LATER REMOVED DURING A PREVIOUSLY SCHEDULED SECOND SURGERY (PANCREATICOJEJUNOSTOMY).

  Patient problems: Device Embedded In Tissue or Plaque; No Code Available

  MAUDE report 6727908 ↗