TorFlex Transseptal Guiding Sheath TF85-32-63-55 (UDI 00685447005407)Recalls & reported problems
Boston Scientific Corporation · TorFlex Transseptal Sheath; Transseptal Dilator; J-Tip Guidewire · Class 2
All models of TorFlex Transseptal Guiding Sheath (3)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00685447005407), received between Mar 4, 2026 and Mar 4, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Jun 10, 2025Class IIOpen, Classified
Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst case scenario. Potential punctures may go undetected in clinical settings due to small size and variable location.
Z-2106-2025 · Root cause: Packaging change control · Recall details · FDA record ↗
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.
MalfunctionMar 4, 2026Break
IT WAS REPORTED THAT BMC TRANSSEPTAL SHEATH WAS SELECTED FOR USE. DURING THE PREPARATION IT WAS MENTIONED THAT THE STOPCOCK BROKE WHEN THE DEVICE WAS DROPPED ON THE TABLE. NO LEAK WAS NOTED NOR ANY DAMAGE WAS NOTED WHEN REMOVED FROM THE PACKAGE. THUS, THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATION WAS REPORTED. THE DEVICE IS NOT EXPECTED TO BE RETURN FOR ANALYSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24508285 ↗
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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 · each recall links to the FDA recall notice
- 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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