Flexor G48190Recalls & 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002481909), received between Jul 3, 2017 and Jul 3, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Leak/Splash” (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
- Leak/Splash1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 3, 2017Leak/Splash; Leak/Splash
IT WAS REPORTED THAT DURING A TIBIAL INTERVENTION USING A FLEXOR SHUTTLE TIBIAL GUIDING SHEATH THE TUOHY WAS LEAKING. IT IS SPECIFICALLY NOT LEAKING ON THE 3 WAY STOP COCK SIDE. IT IS LEAKING WHERE THE CLEAR PLASTIC TUBING IS CONNECTED TO THE WHITE HUB. NO SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THERE WERE NO REPORTED ADVERSE EFFECTS CAUSED OR CONTRIBUTED TO THE PRODUCT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6684081 ↗
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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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