Cope G05183Recalls & reported problems
Cook Incorporated · Cope Mandril Wire Guide Stainless Steel · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Cook Cope mandril wire guide is used to help guide catheters during procedures. Reports mostly describe the wire unraveling or breaking, sometimes leaving a fragment in the patient; there are 41 reports, no deaths, and 17 injuries. One open recall began in August 2022 because packaging seals may be breached, potentially compromising sterility. There were 0 reports in the most recent 12 months, compared with 7 in the previous 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 41
- Deaths reported
- 0
- Injuries reported
- 17
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00827002051836), received between Jul 12, 2016 and Sep 12, 2025 — classified as 17 injuries, 24 malfunctions.
The most frequently reported specific device problem is “Material Separation” (20 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.
Reports received per month
Recalls naming this device
- 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-1830-2022 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Material Separation20
- Unraveled Material15
- Break5
- Difficult to Remove2
- Fracture2
- Material Fragmentation2
- Material Twisted/Bent2
- Entrapment of Device1
Patient problems
- No Known Impact Or Consequence To Patient13
- Foreign Body In Patient9
- No Clinical Signs, Symptoms or Conditions8
- No Code Available8
- Device Embedded In Tissue or Plaque3
- Insufficient Information2
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 12, 2025Unraveled Material; Unraveled Material
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23041973 ↗MalfunctionSep 12, 2025Unraveled Material; Unraveled Material
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23041817 ↗MalfunctionSep 12, 2025Unraveled Material; Unraveled Material
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23041739 ↗MalfunctionMay 21, 2025Unraveled Material; Unraveled Material
IT WAS REPORTED THAT THE COPE MANDRIL WIRE GUIDE UNRAVELED. THE GUIDEWIRE FROM A NEWLY OPENED SET WAS INTRODUCED THROUGH A COMPETITOR NEEDLE FOR PERCUTANEOUS LEFT PORTAL VENOUS ACCESS. UPON INSERTION, THE TIP OF THE WIRE APPEARED TO HAVE PARTIALLY DETACHED AND ELONGATED LIKE A STRING. THE WIRE GUIDE WAS REPLACED WITH A NEW ONE TO SUCCESSFULLY COMPLETE THE PROCEDURE. AS REPORTED, 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 22062533 ↗MalfunctionMay 1, 2025Break; Break
IT WAS REPORTED THAT A COPE MANDRIL WIRE GUIDE BROKE WHILE IN A PATIENT DURING AN UNKNOWN PROCEDURE. AT THIS TIME, NO ADVERSE EFFECTS OR ADDITIONAL PROCEDURES FOR THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Patient problems: Insufficient Information
MAUDE report 21943004 ↗MalfunctionFeb 25, 2025Break; Material Separation; Break; Material Separation
IT WAS REPORTED THAT THE TIP OF A COPE MANDRIL WIRE GUIDE "CAME LOOSE" AND SEPARATED FROM THE MANDRIL. THE DEVICE WAS REQUIRED FOR ACCESS TO THE FEMORAL ARTERY. THE WIRE WAS NOT ALTERED FROM ITS ORIGINAL CONDITION PRIOR TO USE. THE SEPARATION OCCURRED UPON REMOVAL FROM THE ARTERY. NO PORTION OF THE DEVICE WAS LEFT IN THE BODY OF THE PATIENT. THE PROCEDURE WAS COMPLETED BY USING ANOTHER OF THE SAME DEVICE. IT IS UNKNOWN IF ANY RESISTANCE WAS ENCOUNTERED DURING INSERTION OF THE WIRE, OR IF THE WIRE WAS REMOVED THROUGH A NEEDLE OR OTHER INSTRUMENT. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21459606 ↗MalfunctionNov 7, 2024Unraveled Material; Unraveled Material
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20634496 ↗InjuryJun 12, 2023Material Separation; Unraveled Material; Material Separation; Unraveled Material
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 17107931 ↗InjuryMay 8, 2023Break; Fracture; Unraveled Material; Break; Fracture; Unraveled Material
NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Foreign Body In Patient
MAUDE report 16886741 ↗InjuryAug 19, 2021Material Separation; Material Twisted/Bent; Material Separation; Material Twisted/Bent
IT WAS REPORTED THAT DURING A PERMACATH INSERTION, THE TIP OF THE COPE MANDRIL WIRE GUIDE BROKE OFF INTO THE RIGHT SUBCLAVIAN VEIN OF AN UNKNOWN PATIENT. A FOREIGN BODY RETRIEVAL WAS PERFORMED TO SECURE THE TIP. AN ADDITIONAL PUNCTURE AT ANOTHER SITE WAS NEEDED TO RETRIEVE THE BROKEN PIECE OF WIRE GUIDE. NO HARM TO THE PATIENT HAS BEEN REPORTED. ADDITIONAL INFORMATION REGARDING EVENT AND PATIENT DETAILS HAS BEEN REQUESTED, BUT IS CURRENTLY UNAVAILABLE. THE RETRIEVED TIP OF THE WIRE GUIDE IS NOT AVAILABLE FOR RETURN, AS IT WAS FINE AND WAS LOST.
Patient problems: Foreign Body In Patient
MAUDE report 12345962 ↗MalfunctionMay 24, 2021Material Separation; Material Separation
IT WAS REPORTED AN UNKNOWN PATIENT WITH TORTUOUS ANATOMY REQUIRED A COPE MANDRIL WIRE GUIDE FOR AN ATHERECTOMY. DURING THE PROCEDURE IN (B)(6) 2019, THE USER REMOVED THE WIRE GUIDE THROUGH A CATHETER AND DISCOVERED THE END OF THE WIRE GUIDE HAD "CAME UNDONE". THE USER DID NOT OBSERVE KINKING OF THE WIRE GUIDE. THE PROCEDURE WAS COMPLETED WITH ANOTHER UNKNOWN WIRE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11870888 ↗MalfunctionMar 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: Insufficient Information
MAUDE report 11416852 ↗MalfunctionDec 22, 2020Unraveled Material; Unraveled Material
IT WAS REPORTED AN UNKNOWN PATIENT REQUIRED A COPE MANDRIL WIRE GUIDE FOR A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE PLACEMENT IN THE RIGHT ARM. DURING THE PROCEDURE, THE WIRE BECAME LODGED IN THE PATIENT'S SCAR TISSUE. WHEN THE OPERATOR ATTEMPTED TO REMOVE THE WIRE BY PULLING IT BACK, THE WIRE UNRAVELED. AFTER SEVERAL ATTEMPTS AT REMOVAL, THE WIRE WAS "RETRIEVED". AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 11061393 ↗InjuryOct 12, 2020Material Separation; Material Separation
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Device Embedded In Tissue or Plaque; No Code Available
MAUDE report 10662452 ↗InjuryAug 27, 2020Material Separation; Unraveled Material; Material Separation; Unraveled Material
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Device Embedded In Tissue or Plaque; No Code Available
MAUDE report 10462630 ↗MalfunctionJun 16, 2020Unraveled Material; Unraveled Material
IT WAS REPORTED A COPE MANDRIL WIRE GUIDE WAS UTILIZED IN AN UNKNOWN PROCEDURE. WHEN BEING WITHDRAWN THROUGH THE MICROPUNCTURE NEEDLE, THE WIRE GUIDE "SHEARED." NO OTHER ADVERSE EFFECTS WERE REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10157414 ↗MalfunctionMay 8, 2020Unraveled Material; 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 10039250 ↗InjuryDec 3, 2019Material 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; No Code Available
MAUDE report 9401281 ↗InjuryDec 3, 2019Material 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 9400801 ↗InjuryNov 19, 2019Material 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 9340818 ↗MalfunctionOct 2, 2019Unraveled Material; Material Twisted/Bent; Unraveled Material; Material Twisted/Bent
InjuryMay 28, 2019Material 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 8645394 ↗MalfunctionMay 24, 2019Material Separation; Material Separation
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 8640177 ↗InjuryMay 21, 2019Material Separation; Material Separation
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 8628128 ↗InjuryMay 21, 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 8627983 ↗
Other WIRE, GUIDE, CATHETER devices
- HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II 1009664Abbott Vascular Inc. · WIRE, GUIDE, CATHETER321 reports
- SYNCHRO 14 M00313010Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls220 reports
- PressureWire™ C12059Lightlab Imaging, Inc. · WIRE, GUIDE, CATHETER1 death296 reports
- SYNCHRO 2 M00326410Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls155 reports
- ENROUTE .014" Guidewire 11686-01Silk Road Medical, Inc. · Wire, Guide, Catheter2 deaths228 reports
- ARROW IPN035915Teleflex Incorporated · WIRE, GUIDE, CATHETER217 reports
- OmniWire Pressure guide wire 89185Philips Image Guided Therapy Corporation · Wire, Guide, Catheter1 recall1 death160 reports
- ARROW IPN055780Teleflex Incorporated · Wire, guide, catheter4 recalls0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.