Flexor G48193Recalls & reported problems
Cook Incorporated · Flexor, Tuohy-Borst Side-Arm Introducer Shuttle,-SL · Class 2
All models of Flexor (134)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002481930), received between Sep 19, 2022 and Sep 19, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Unraveled Material” (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
- Unraveled Material1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 19, 2022Unraveled Material; Unraveled Material
AS REPORTED, UPON COMPLETION OF AN ENDOVASCULAR PROCEDURE INVOLVING THE SUPERFICIAL FEMORAL ARTERY, A FLEXOR SHUTTLE TIBIAL GUIDING SHEATH UNRAVELED AND SEPARATED UPON REMOVAL OF THE DEVICE FROM THE PATIENT. MINIMAL RESISTANCE WAS ENCOUNTERED PRIOR TO THE DEVICE UNRAVELING/SEPARATING IN THE MIDDLE OF THE SHEATH. AN INCISION WAS MADE, AND AN OPEN SURGICAL APPROACH WAS USED TO REMOVE THE DEVICE FROM THE PATIENT. NO ADDITIONAL COMPLICATIONS WERE REPORTED. PHOTOS PROVIDED BY THE CUSTOMER SHOW THAT AN UNKNOWN WIRE WAS IN THE SHEATH LUMEN. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Foreign Body In Patient
MAUDE report 15445765 ↗
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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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