Flexor G09908Recalls & reported problems
Cook Incorporated · Flexor, Check-Flo, Introducer Set · Class 2
- Adverse event reports
- 15
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00827002099081), received between Jun 19, 2020 and Jul 9, 2021 — classified as 15 malfunctions.
The most frequently reported specific device problem is “Nonstandard Device” (12 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.
Most reported problems
Device problems
- Nonstandard Device12
- Fluid/Blood Leak2
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions14
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 9, 2021Fluid/Blood Leak; Fluid/Blood Leak
NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12142496 ↗MalfunctionJun 17, 2021Nonstandard Device; Nonstandard Device
NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12016904 ↗MalfunctionJun 16, 2021Nonstandard Device; Nonstandard Device
NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12011899 ↗MalfunctionJun 16, 2021Nonstandard Device; Nonstandard Device
NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12011877 ↗MalfunctionJun 16, 2021Nonstandard Device; Nonstandard Device
NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAT REPORT WAS SUBMITTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12011848 ↗MalfunctionJun 16, 2021Nonstandard Device; Nonstandard Device
NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12011765 ↗MalfunctionJun 16, 2021Nonstandard Device; Nonstandard Device
NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12011760 ↗MalfunctionJun 16, 2021Nonstandard Device; Nonstandard Device
NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12011592 ↗MalfunctionJun 16, 2021Nonstandard Device; Nonstandard Device
NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12011419 ↗MalfunctionJun 16, 2021Nonstandard Device; Nonstandard Device
NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12010452 ↗MalfunctionJun 16, 2021Nonstandard Device; Nonstandard Device
NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12010429 ↗MalfunctionJun 16, 2021Nonstandard Device; Nonstandard Device
NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12010403 ↗MalfunctionJun 14, 2021Nonstandard Device; Nonstandard Device
AS REPORTED, UPON INSERTION OF A FLEXOR INTRODUCER SHEATH DURING AN "AFS" PROCEDURE, THE RADIOPAQUE BAND WAS NOTED TO BE UNDER THE HUB OF THE DEVICE RATHER THAN AT THE DISTAL END OF THE SHEATH. THE ISSUE WAS NOTICED IMMEDIATELY UPON ATTEMPTED INSERTION AND THE USER DID NOT CONTINUE WITH THE INTRODUCER. REPORTEDLY, FIVE DEVICES IN TOTAL WERE AFFECTED, TWO USED AND THREE UNUSED. 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 Clinical Signs, Symptoms or Conditions
MAUDE report 11992336 ↗MalfunctionApr 1, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
NO NEW PATIENT OR EVENT INFORMATION TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11601596 ↗MalfunctionJun 19, 2020Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED, DURING AN UNSPECIFIED EMBOLIZATION PROCEDURE, A FLEXOR INTRODUCER SHEATH LEAKED AT THE HUB. THERE WERE REPORTEDLY NO CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IS UNAVAILABLE AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10174721 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.