Flexor G09602Recalls & reported problems
Cook Incorporated · Flexor, Check-Flo, Introducer Set · Class 2
All models of Flexor (134)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002096028), received between Jul 23, 2018 and Aug 27, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 reports).
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
- Detachment of Device or Device Component3
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 27, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, DURING AN UNSPECIFIED AORTIC INTERVENTION CASE, THE HUB OF A FLEXOR INTRODUCER SHEATH SEPARATED FROM THE DEVICE. THE ANATOMY WAS REPORTEDLY TORTUOUS. ALTHOUGH THE CUSTOMER REPORTED THAT THE FLEXOR HUB SEPARATED UPON REMOVAL OF THE DEVICE FROM ANOTHER MANUFACTURER¿S SHEATH, THE CUSTOMER ALSO REPORTED THAT THE OTHER MANUFACTURER¿S SHEATH WAS USED THROUGH THE FLEXOR SHEATH. PER THE REPORTER, THE DILATOR WAS REINSERTED PRIOR TO SHEATH REMOVAL OVER AN UNSPECIFIED WIRE GUIDE. A NEW FLEXOR SHEATH WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22905266 ↗MalfunctionDec 2, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10936482 ↗MalfunctionJul 23, 2018Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED, THE HEMOSTATIC VALVE ON THE FLEXOR INTRODUCER SHEATH DISCONNECTED COMPLETELY WHILE THE DEVICE WAS BEING FLUSHED, PRIOR TO USE. ANOTHER FLEXOR INTRODUCER SHEATH WAS SUCCESSFULLY PREPARED AND USED TO COMPLETE THE UNSPECIFIED PROCEDURE. THE DEVICE NEVER MADE CONTACT WITH THE PATIENT. ACCORDING TO THE INITIAL REPORTER THE PROCEDURE "WENT VERY WELL" AND THE "PATIENT IS FINE".
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7711350 ↗
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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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