SureFlex Steerable Guiding Sheath TSK85-32-BD-71LRecalls & reported problems
Boston Scientific Corporation · SureFlex Steerable Sheath; Transseptal Dilator; J-Tip Guidewire · Class 2
Data updated Oct 13, 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 00685447006329), received between Sep 11, 2024 and Sep 11, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Defective Device” (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.
Reports received per month
Most reported problems
Device problems
- Defective Device1
- Flushing Problem1
- Material Perforation1
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.
MalfunctionSep 11, 2024Flushing Problem; Material Perforation; Defective Device; Flushing Problem; Material Perforation; Defective Device
IT WAS REPORTED THAT A SUREFLEX BMC STEERABLE SHEATH WAS SELECTED FOR USE FOR AN ABLATION PROCEDURE. DURING THE PROCEDURE, WHEN ATTEMPTED WAS MADE TO REMOVE AN ORION FROM THE VERSACROSS SHEATH, THE FLUSHING PORT FELL OUT. THE FLUSHING PORT WAS NOT PULLED, BUT A POPPING SOUND WAS HEARD, AND THE BASE FELL OUT FROM THE BASE. THE FLUSHING WAS NOT POSSIBLE TO BE PERFORMED. THUS, THE DEVICE WAS REPLACED WITH ANOTHER SAME MODEL DEVICE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATION WAS REPORTED. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20191133 ↗
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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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