Flexor G10406Recalls & reported problems
Cook Incorporated · Flexor, Check-Flo, Introducer Balkin Up & Over, Contralateral Design · Class 2
All models of Flexor (134)
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 00827002104068), received between Jul 2, 2024 and Jul 2, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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
- Break1
- Unraveled Material1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 2, 2024Break; Unraveled Material; Break; Unraveled Material
AS REPORTED, DURING A ¿LR¿ RUNOFF AND AORTOGRAM UNDER CONSCIOUS SEDATION, A FLEXOR BALKIN GUIDING SHEATH UNRAVELED AND SEPARATED IN THE PATIENT. THE PATIENT HAD A HISTORY OF ATHEROSCLEROSIS AND PAIN IN THE LEFT LEG, AS WELL AS EXTERNAL ILIAC ARTERY DISEASE. ULTRASOUND GUIDED MICROPUNCTURE ACCESS WAS OBTAINED IN THE RIGHT FEMORAL ARTERY USING A COOK 4-FRENCH MICROPUNCTURE KIT. THE PATIENT'S GROIN (ACCESS SITE) WAS REPORTEDLY CALCIFIED AND SCARRED. A FULL AND COMPLETE DIAGNOSTIC PERIPHERAL ANGIOGRAPHY OF THE RIGHT LEG WAS PERFORMED. THE MICROPUNCTURE SHEATH WAS UPSIZED TO ANOTHER MANUFACTURER¿S 6-FRENCH, 10-CENTIMETER SHEATH, AND THE USER CROSSED OVER TO THE LEFT COMMON ILIAC ARTERY, USING ANOTHER MANUFACTURER¿S ¿UF¿ CATHETER AND A ¿SOFT STORQ¿ WIRE. ANOTHER MANUFACTURER¿S WIRE WAS THEN USED TO CROSS A CHRONIC TOTAL OCCLUSION/LESION WITHIN THE LEFT EXTERNAL ILIAC ARTERY. THE USER THEN ATTEMPTED TO EXCHANGE THE OTHER MANUFACTURER¿S SHEATH FOR THE COMPLAINT DEVICE. THE SHEATH WOULD NOT ADVANCE OVER THE WIRE GUIDE, SO THE WIRE WAS REPLACED WITH A COOK AMPLATZ .035 STIFF WIRE; HOWEVER, THE SHEATH WOULD ONLY ADVANCE TWO INCHES OR LESS INTO THE PATIENT. THE USER THEN INSERTED THE DILATOR A
Patient problems: Foreign Body In Patient
MAUDE report 19661238 ↗
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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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