Coons G02621Recalls & reported problems
Cook Incorporated · Coons Interventional Wire Guide · 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
- 8
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00827002026216), received between Aug 26, 2016 and Aug 5, 2019 — classified as 2 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Unraveled Material” (5 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
- 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-1828-2022 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Unraveled Material5
- Difficult to Remove3
- Material Protrusion/Extrusion1
- Material Separation1
- Uncoiled1
Patient problems
- No Known Impact Or Consequence To Patient5
- No Code Available2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 5, 2019Material Separation; Material Separation
AS REPORTED, DURING AN UNKNOWN PROCEDURE INVOLVING A PATIENT OF UNKNOWN AGE AND GENDER, A COONS INTERVENTIONAL WIRE GUIDE "BROKE" ON A "BILIARY PATIENT". ADDITIONAL INFORMATION REGARDING EVENT DETAILS, PATIENT ANATOMY AND OUTCOME HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8861180 ↗MalfunctionJun 13, 2019Material Protrusion/Extrusion; Material Protrusion/Extrusion
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8695584 ↗MalfunctionJul 28, 2017Uncoiled; Uncoiled
IT WAS REPORTED THAT DURING A ROUTINE FISTULOGRAM PROCEDURE WITH A GUIDE WIRE IN PLACE AND A KUMPE CATHETER, THE WIRE BEGAN TO UNCOIL WHILE REMOVING THE CATHETER BACK OVER THE WIRE. EVERYTHING WAS REMOVED TO END THE PROCEDURE AND A TEMPORARY DIALYSIS ACCESS PORT WAS PLACED DUE TO THE PATIENT'S VASOSPASM CONDITION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6751584 ↗MalfunctionSep 6, 2016Difficult to Remove; Unraveled Material; Difficult to Remove; Unraveled Material
DURING A AVF (ARTERIOVENOUS FISTULA) DECLOT OF THE UPPER EXTREMITY THE DEVICE UNRAVELED AND GOT STUCK IN THE AVF BALLOONS. IT IS REPORTED THE WIRE GOT STUCK IN THE BALLOON CATHETER AND AS THE PHYSICIAN PULLED HARDER ON THE WIRE, IT BEGAN TO COME UNWOUND. EVERYTHING WAS ABLE TO RETRIEVED DURING THE SAME PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. ACCORDING TO THE INITIAL REPORTER, 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 5928878 ↗MalfunctionSep 6, 2016Unraveled Material; Unraveled Material
DURING AN AVF DE-CLOTTING PROCEDURE, THE DEVICE UNRAVELED AND GOT STUCK IN THE AVF BALLOONS. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION WAS REQUESTED, HOWEVER IT WAS NOT PROVIDED AT THE TIME OF THIS REPORT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5928721 ↗InjuryAug 31, 2016Difficult to Remove; Unraveled Material; Difficult to Remove; Unraveled Material
THE DEVICE UNRAVELED AND GOT STUCK IN THE AVF BALLOONS. PER COMPLAINT FORM, AFTER 5TH INCIDENT, THE UNUSED / UNOPENED LOTS WERE REMOVED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY.
Patient problems: No Code Available
MAUDE report 5916998 ↗InjuryAug 29, 2016Difficult to Remove; Unraveled Material; Difficult to Remove; Unraveled Material
INITIAL INFORMATION PROVIDED STATES: THE DEVICE UNRAVELED AND GOT STUCK IN THE AVF BALLOONS. PER COMPLAINT FORM, AFTER 5TH INCIDENT, THE UNUSED / UNOPENED LOTS WERE REMOVED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. ADDITIONAL INFORMATION PROVIDED INDICATED THE FOLLOWING: THE PHYSICIAN HAD A VERY DETRIMENTAL PRODUCT(S) FAILURE ASSOCIATED WITH THE COONS INTERVENTIONAL WIRE GUIDE. HE EXPERIENCED THREE WIRE FAILURES OF VARYING LOT NUMBERS IN THE SAME PROCEDURE ON THE SAME PATIENT. THIS REQUIRED AN EXTENDED STAY IN ICU AS WELL AS FAILURE OF A PREVIOUSLY PATENT AVF FOR DIALYSIS. INITIALLY ONE OF THE WIRES GOT STUCK IN A DIAGNOSTIC CATHETER (1820334-2016-00898), AFTER REMOVING ALL PRODUCTS WITH THE EXCEPTION OF THE SHEATH, WIRE ACCESS WAS GAINED AGAIN ACROSS THE LESION. UPON DEFLATING THE PTA BALLOON CATHETER IT WAS NOTED THE CATHETER WAS STUCK ON YET AGAIN ANOTHER COON'S WIRE (1820334-2016-00899). THIS PARTICULAR INCIDENT WAS CRITICAL AS THE SUBCLAVIAN A. HAD RUPTURED; HAD THE PTA CATHETER NOT GOTTEN STUCK, WIRE ACCESS ACROSS THE RUPTURE WOULD HAVE MADE PLACING A COVERED STENT GRAFT EASIER THUS SAVING THE AVF. INSTEAD, ONCE AGAIN, EVERYTHING ASIDE FROM THE SHEATH
Patient problems: No Code Available
MAUDE report 5910769 ↗MalfunctionAug 26, 2016Unraveled Material; Unraveled Material
THE DEVICE UNRAVELED AND GOT STUCK IN THE AVF BALLOONS. PER COMPLAINT FORM, AFTER (B)(4) INCIDENT, THE UNUSED / UNOPENED LOT'S WERE REMOVED. 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 Known Impact Or Consequence To Patient
MAUDE report 5908189 ↗
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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