Cook G00552Recalls & reported problems
Cook Incorporated · Fixed Core Wire Guide Safe-T-J, Curved · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002005525), received between Jan 26, 2018 and Jan 26, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Unraveled Material” (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-1833-2022 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Unraveled Material1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 26, 2018Unraveled Material; Unraveled Material
THE CUSTOMER REPORTED THAT, DURING A DEEP PELVIC ABSCESS DRAINAGE PROCEDURE, THE SAFE-T-J FIXED CORE WIRE GUIDE GOT CAUGHT INSIDE THE METAL STIFFENER WHEN THE CATHETER WAS INTRODUCED OVER THE WIRE. THE USER MANAGED TO PULL THE WIRE OUT EVENTUALLY, BUT REPORTED THAT THE WIRE HAD BEGUN TO UNRAVEL. A POST-PROCEDURE COMPUTED TOMOGRAPHY SCAN CONFIRMED THAT NO PIECES OF THE WIRE GUIDE WERE LEFT IN THE PATIENT - THE WIRE WAS REMOVED IN ITS ENTIRETY. THE OPERATOR OF THE DEVICE STATED THAT THERE MAY HAVE BEEN TOO MUCH WIRE IN THE ABSCESS, WHICH CAUSED THE WIRE TO KINK WHEN THE METAL STIFFENER WAS INTRODUCED. THE AMOUNT OF WIRE THAT HAD BEEN LOOPED IN THE ABSCESS WAS NOT READILY OBSERVABLE, BECAUSE THIS PROCEDURE WAS DONE UNDER ULTRASOUND GUIDANCE, RATHER THAN FLUOROSCOPY. THE ABSCESS WAS REPORTEDLY DEEP IN THE PATIENT'S PELVIS, AND WAS ONLY ABOUT 5-7 CM IN DIAMETER. THE WIRE 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 7222787 ↗
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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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