SCANLAN® Vascular Tunneler Sheaths and Bullet Tips 9009-18Recalls & reported problems
Scanlan International Inc · Small (green) for grafts up to 8 mm, 20 1/2" / 52 cm (1/pkg) · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00846159000986), received between Mar 28, 2024 and Jul 21, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component4
Patient problems
- Foreign Body In Patient3
- Hematoma1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 21, 2026Detachment of Device or Device Component
Patient problems: Foreign Body In Patient
MAUDE report 25894209 ↗MalfunctionJun 16, 2026Detachment of Device or Device Component
EMAIL RECEIVED REPORTED: 9009-18 BECAME FAULTY DURING A CASE; STATING BULLET TIP HAD A LOOSE FIT AND BECAME DISCONNECTED, AND THE SURGEON HAD TO FISH IT OUT OF THE PATIENT.
Patient problems: Hematoma
MAUDE report 25523613 ↗MalfunctionMar 28, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
"THE CAP BECAME DISLODGED DURING POSITION ADJUSTMENT. UNDER FLURO THE CAP WAS FOUND. THE INCISION WAS EXTENDED. THE FASCIA AND ABDUCTOR MAGNUS WAS DEVIDED TO RETRIEVE THE CAP, DEEP IN THE FEMUR. ONE ARTERIAL AND VENOUS BRANCH PAIR OF THE DISTAL PROFUNDA FEMORIAL ARTERY AVULSED AND REQUIRED REPAIR. THIS ADDED AT LEAST ONE HOUR OF SURGERY TIME." AS REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 18998976 ↗MalfunctionMar 28, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
"CREATING A BELOW KNEE TO FEM TUNNEL, THE CAP OF THE TUNNELER BECAME SEPARATED FROM THE SHAFT AND DISLODGED IN THE PATIENT IN PROXIMAL THIGH. REQUIRED COUNTER INCISION FOR RETRIEVAL OF THE CAP." AS REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 18998906 ↗
Other Instruments, Surgical, Cardiovascular devices
- ACCESSRAIL Platform (Standard Blade) SB-1000Maquet Cardiovascular LLC · Instruments, Surgical, Cardiovascular1 recall6 reports
- ADVANTA SLIDER GDS 22025Atrium Medical Corporation · INSTRUMENTS, SURGICAL, CARDIOVASCULAR1 recall0 reports
- ADVANTA SLIDER GDS 22092Atrium Medical Corporation · INSTRUMENTS, SURGICAL, CARDIOVASCULAR1 recall0 reports
- Needle NDL-107-04Galt Medical Corp. · Instruments, Surgical, Cardiovascular1 recall0 reports
- ADVANTA SLIDER GDS 22125Atrium Medical Corporation · INSTRUMENTS, SURGICAL, CARDIOVASCULAR1 recall0 reports
- Lead Clippers G20003Cook Vandergrift Inc. · INSTRUMENTS, SURGICAL, CARDIOVASCULAR1 recall0 reports
- PILLING IPN005932Teleflex Incorporated · INSTRUMENTS, SURGICAL, CARDIOVASCULAR18 reports
- PILLING IPN915270Teleflex Incorporated · INSTRUMENTS, SURGICAL, CARDIOVASCULAR16 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page