GLIDESHEATH 30-1050Recalls & reported problems
Terumo Medical Corporation · GLIDESHEATH Access Kit Hydrophilic Coated Introducer Sheath · Class 2
Data updated Oct 13, 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 00389701011219), received between Oct 10, 2022 and Oct 10, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Peeled/Delaminated” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Peeled/Delaminated1
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.
InjuryOct 10, 2022Peeled/Delaminated; Peeled/Delaminated
THE USER FACILITY REPORTED THAT THE DOCTOR HAD A PATIENT HE WAS REVIEWING THAT HAD A RADIAL TO PERIPHERAL (R2P) PROCEDURE TEN-DAY PRIOR WHICH HAD TO HAVE OPEN SURGERY ON. THE DOCTOR STATED THAT THE PATIENT HAD TO HAVE THEIR HAND OPENED AND BLACK PIECES OF THE ACCESS WIRE THAT HAD SHEARED OFF WERE REMOVED. THE PATIENT CONDITION WAS STABLE. ADDITIONAL INFORMATION WAS RECEIVED ON 06 OCT 2022: THERE WAS MINIMAL BLOOD LOSS. THE PROCEDURE WAS SUCCESSFUL IN REMOVING THE BLACK PIECES. A 60-1050 WIRE WAS USED WITH A 80-1050 NEEDLE. THEY DID NOT USE THE A-KIT WIRE WITH THE SHEATH DESIGNED FOR THE A-KIT. THE NEEDLE SHEERED OFF THE WIRE INTO THE HAND.
Patient problems: Foreign Body In Patient
MAUDE report 15569138 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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