Cook G00652Recalls & reported problems
Cook Incorporated · Fixed Core Wire Guide Straight · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002006522), received between Jul 25, 2016 and Aug 10, 2016 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Difficult to Remove” (1 report).
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
- 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-1834-2022 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Appropriate Device Problem Term/Code Not Available1
- Difficult to Remove1
- Material Frayed1
- Unintended Movement1
Patient problems
- No Known Impact Or Consequence To Patient2
- No Consequences Or Impact To Patient1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 10, 2016Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THE AREA REP PROVIDED INFORMATION THAT A STRAIGHT EXCHANGE FIXED CORE WIRE GUIDE UNRAVELED INSIDE ANOTHER MANUFACTURER'S VACCESS BALLOON. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5865548 ↗MalfunctionJul 25, 2016Material Frayed; Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Unintended Movement; Material Frayed; Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Unintended Movement
IT WAS REPORTED DURING A PERM CATH INSERTION PROCEDURE THAT A WIRE UNRAVELED INSIDE THE PATIENT. THE UNRAVELED WIRE WAS ENTIRELY REMOVED FROM THE PATIENT. A NEW PRODUCT WAS OPENED AND USED TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient; Pain
MAUDE report 5818677 ↗
Other WIRE, GUIDE, CATHETER devices
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- 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.