Flexor G11897Recalls & reported problems
Cook Incorporated · Flexor, Check-Flo, Introducer Raabe Modification · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00827002118973), received between May 17, 2018 and Dec 16, 2025 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Component Missing” (2 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Component Missing2
- Detachment of Device or Device Component2
- Material Split, Cut or Torn1
- Unsealed Device Packaging1
Patient problems
- No Known Impact Or Consequence To Patient3
- No Consequences Or Impact To Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 16, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
AS REPORTED, DURING AN ANGIOGRAM WITH PERCUTANEOUS CATHETER THROMBOLYSIS AND ASPIRATION OF ARTERIAL THROMBUS IN THE LEFT LOWER EXTREMITY, A TEAR WAS NOTED AT THE TIP OF A FLEXOR RAABE GUIDING SHEATH'S DILATOR. PER THE REPORTER, THE TEAR WAS "NON-HUMAN INDUCED". THE SHEATH WAS IMMEDIATELY REPLACED WITH ANOTHER DEVICE OF THE SAME TYPE, AND THE PROCEDURE WAS COMPLETED. 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 23821174 ↗MalfunctionNov 17, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, DURING AN UNKNOWN PROCEDURE, THE VALVE OF A FLEXOR RAABE GUIDING SHEATH SEPARATED FROM THE SHEATH. 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IS UNAVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10854039 ↗MalfunctionOct 14, 2020Unsealed Device Packaging; Unsealed Device Packaging
NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10680696 ↗MalfunctionFeb 26, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8370034 ↗MalfunctionMay 18, 2018Component Missing; Component Missing
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7525862 ↗MalfunctionMay 17, 2018Component Missing; Component Missing
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7523530 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- 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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