SCANLAN® Vascular Tunneler Sheaths and Bullet Tips 9009-16Recalls & reported problems
Scanlan International Inc · Large (blue) for grafts up to 10 mm, 20 1/2" / 52 cm (1/pkg) · Class 1
Data updated Oct 18, 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 00846159000979), received between Sep 5, 2017 and Sep 5, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment Of Device Component” (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 18, 2026.
Most reported problems
Device problems
- Detachment Of Device Component1
- Entrapment of Device1
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 5, 2017Detachment Of Device Component; Entrapment of Device
WHILE PASSING THE TUNNELER DURING AN AXILLO-BIFEMORAL BYPASS THE BULLET TIP SEPARATED FROM THE TUNNELER DEVICE AND REMAINED IN THE PATIENT. X-RAY WAS PERFORMED TO LOCATE THE BULLET TIP AND THE TIP WAS RETRIEVED.
Patient problems: Foreign Body In Patient
MAUDE report 6843293 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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