SureFlex Steerable Guiding Sheath TSK0006Recalls & 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 00685447006237), received between Apr 30, 2024 and Apr 30, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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
- Adverse Event Without Identified Device or Use Problem1
- Device-Device Incompatibility1
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.
MalfunctionApr 30, 2024Device-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Device-Device Incompatibility; Adverse Event Without Identified Device or Use Problem
REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(6)2024. IT WAS REPORTED THAT A SUREFLEX STEERABLE GUIDING SHEATH WAS SELECTED FOR USE FOR AN ABLATION PROCEDURE INDICATED FOR A CASE OF VENTRICULAR TACHYCARDIA (VT). DURING THE PROCEDURE, IT WAS MENTIONED THAT THE HEMOSTASIS VALVE WAS INSERTED TIGHTLY, AND THE CATHETER BECAME DAMAGED. THE PROCEDURE WAS STILL COMPLETED SUCCESSFULLY USING THE ORIGINAL DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. PRODUCT IS AVAILABLE FOR RETURN. IT HAS BEEN FURTHER MENTIONED THAT THE ABLATION CATHETER WAS NOT PROTRUDING OUT OF THE SHEATH WHEN THE ISSUE OCCURRED. HOWEVER, THE ANALYSIS OF THE DEVICE REVEALED A DAMAGE ON ITS VALVE, SHEATH TIP AND HUB.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19212938 ↗
Other Introducer, Catheter devices
- VIZIGO D138502Biosense Webster Inc · INTRODUCER, CATHETER2 recalls4 deaths2,839 reports
- VIZIGO D138501Biosense Webster Inc · INTRODUCER, CATHETER2 recalls2 deaths2,005 reports
- Swartz™ 407451St. Jude Medical, Inc. · INTRODUCER, CATHETER5 deaths728 reports
- Edwards eSheath+ Introducer set 914ESPEdwards Lifesciences LLC · Introducer, Catheter22 deaths532 reports
- Fast-Cath™ 406849St. Jude Medical, Inc. · INTRODUCER, CATHETER420 reports
- VIZIGO D138503Biosense Webster Inc · INTRODUCER, CATHETER362 reports
- 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 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.
How reports and recalls are matched · Editorial policy · Report an error on this page