TourGuide™ Steerable Sheath TG0704517Recalls & reported problems
Oscor Inc. · Steerable Sheath, 7F · Class 2
All models of TourGuide Steerable Sheath (9)
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 00850232006062), received between Nov 17, 2022 and Nov 17, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 17, 2022Break; Break
IT WAS REPORTED "APTUS TOURGUIDE STEERABLE SHEATH BROKE DURING USE. SHEATH SEPARATED FROM THE HANDLE. PACKAGING AND SHEATH PIECES SAVED AT OR CONTROL DESK. SUBSTITUTE ITEM WAS USED FOR THE REMAINDER OF THE PROCEDURE. AT THIS TIME WE DO NOT KNOW THE LOT NUMBER FOR THIS SPECIFIC SAMPLE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15816376 ↗
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- Agilis™ G408318St. Jude Medical, Inc. · INTRODUCER, CATHETER333 reports
- Agilis™ NxT Steerable Introducer Dual-Reach™ SI-1371-MSt. Jude Medical, Inc. · Introducer, catheter1 death301 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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