Cook G52834Recalls & reported problems
Cook Incorporated · Endovascular Dilator Set Coons Dilator · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002528345), received between Feb 20, 2025 and Feb 20, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (1 report).
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Inadequacy of Device Shape and/or Size1
Patient problems
- Vascular Dissection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 20, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
COOK WAS NOTIFIED THAT A DISSECTION OF THE RIGHT COMMON FEMORAL ARTERY WAS IDENTIFIED THIRTY-FIVE DAYS AFTER THE USE OF COOK PRODUCTS IN A FOUR-VESSEL FENESTRATED ENDOVASCULAR AORTIC REPAIR (FEVAR). THE PATIENT UNDERWENT PREOPERATIVE COMPUTED TOMOGRAPHY (CT) SCAN ON (B)(6) 2024, 48 DAYS PRIOR TO THE PROCEDURE. THE CT SCAN WAS COMPLETED BY THE SITE AND IDENTIFIED THE FOLLOWING: PER PATIENT ECRF: PRE-PROCEDURE IMAGING WAS COMPLETED ON (B)(6) 2024, 48 DAYS PRIOR TO THE PROCEDURE. THE PROXIMAL SEALING ZONE DID NOT HAVE ANY OCCLUSIVE DISEASE OR THROMBUS. HOWEVER MILD CALCIFICATION WAS PRESENT. THE PROXIMAL SEALING ZONE WAS DESCRIBED AS PARALLEL. THE RIGHT COMMON ILIAC ARTERY LEFT COMMON ILIAC ARTERY, RIGHT EXTERNAL ILIAC ARTERY, LEFT EXTERNAL ILIAC ARTERY, RIGHT FEMORAL ARTERY, LEFT FORMAL ARTERY DID NOT HAVE ANY OCCLUSIVE DISEASE. THE RIGHT COMMON ILIAC ARTERY HAD MILD CALCIFICATION. THE LEFT COMMON ILIAC ARTERY HAD MILD CALCIFICATION. THE RIGHT ILIAC ARTERY TORTUOSITY WAS DESCRIBED TO BE MILD. THE LEFT ILIAC ARTERY TORTUOSITY WAS DESCRIBED TO BE MILD. THE AORTA DIAMETER AT THE LOCATION OF THE MAXIMUM ANEURYSM DIAMETER (OUTER-WALL TO OUTER-WALL) WAS 55 MM. THE LENGTH OF THE SUITABLE PR
Patient problems: Vascular Dissection
MAUDE report 21424302 ↗
Other DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION devices
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- TandemLife 5740-2417Cardiacassist, Inc. · Dilator, Vessel, For Percutaneous Catheterization2 recalls0 reports
- TightRail Rotating Dilator Sheath 545-513Spectranetics Corporation · Dilator, Vessel, For Percutaneous Catheterization20 deaths74 reports
- VersaCross Connect LAAC Access Solution VXAK0003Baylis Médicale Cie Inc · Dilator, Vessel, For Percutaneous Catheterization2 deaths70 reports
- VersaCross Connect LAAC Access Solution VXAK0007Baylis Médicale Cie Inc · Dilator, Vessel, For Percutaneous Catheterization2 deaths54 reports
- AVANTI 504656XCordis Corporation · DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION1 recall2 reports
- Abiomed® 00884450732311Merit Medical Systems, Inc. · Dilator, Vessel, For Percutaneous Catheterization1 recall1 report
- Mini Stick MAX H965457510Angiodynamics, Inc. · DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION1 recall1 report
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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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