Flexor G12656Recalls & 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
- 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 00827002126565), received between May 15, 2017 and Jul 1, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (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. 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
- Break2
- Insufficient Device Problem Information1
- Unraveled Material1
Patient problems
- Foreign Body In Patient1
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- 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.
MalfunctionJul 1, 2025Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information
AS REPORTED, DURING AN UNKNOWN PROCEDURE, A FLEXOR BALKIN GUIDING SHEATH WAS "DEFECTIVE". A SECTION OF THE DEVICE REMAINED IN THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 22372901 ↗MalfunctionAug 2, 2023Unraveled Material; Unraveled Material
AS REPORTED, DURING AN UNKNOWN PROCEDURE, TWO FLEXOR BALKIN GUIDING SHEATHS UNRAVELED UPON REMOVAL OF THE DEVICES FROM THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 17443332 ↗MalfunctionMay 15, 2017Break
THE TIP OF THE DILATOR WAS DAMAGED. IT WAS NOT POSSIBLE TO INTRODUCE THE SHEATH. THERE WAS NO REPORT OF ADVERSE EFFECTS TO THE PATIENT. IMAGES OF THE DEVICE DEPICTED ABRAISED AREAS AT THE DISTAL TIP OF THE SHEATH.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6566357 ↗
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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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