Flexor G07465Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002074651), received between May 18, 2017 and Oct 11, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Connection Problem” (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.
Most reported problems
Device problems
- Connection Problem1
- Peeled/Delaminated1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 11, 2022Peeled/Delaminated; Peeled/Delaminated
AS REPORTED, DURING A PROCEDURE INVOLVING RETRIEVAL OF AN UNSPECIFIED INFERIOR VENA CAVA FILTER, A FLEXOR GUIDING SHEATH DELAMINATED. PER THE CUSTOMER, THE SHEATH LEFT BEHIND A "WEIRD PLASTIC STRING" WHEN REMOVED FROM THE NECK ACCESS SITE. PER THE REPORTER, THERE WAS NO HARM OR COMPLICATIONS FOR THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15580970 ↗MalfunctionMay 18, 2017Connection Problem
UPON OPENING THE PACKAGE, THE USER NOTICED THAT THE SEPARATION BETWEEN THE CHECK-FLO AND TUBE OF THE STOP-COCK. THERE WAS NO REPLACEMENT DEVICE, SO HE USED WITH ADHERED WITH THE TAPE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6576646 ↗
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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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