SureFlex Steerable Guiding SheathRecalls & reported problems across all models

We found 6 models of SureFlex Steerable Guiding Sheath by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 24 adverse event reports in the FDA's MAUDE database, received between Mar 29, 2023 and Aug 12, 2026 — classified as 3 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Defective Device” (8 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported SureFlex Steerable Guiding Sheath problems

SureFlex Steerable Guiding Sheath models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• SureFlex Steerable Guiding Sheath TSK0004

  Introducer, Catheter
  13 reports
• SureFlex Steerable Guiding Sheath TSK0005

  Introducer, Catheter
  4 reports
• SureFlex Steerable Guiding Sheath TSK85-32-BD-71S

  Introducer, Catheter
  3 reports
• SureFlex Steerable Guiding Sheath TSK85-32-BD-71M

  Introducer, Catheter
  2 reports
• SureFlex Steerable Guiding Sheath TSK0006

  Introducer, Catheter
  1 report
• SureFlex Steerable Guiding Sheath TSK85-32-BD-71L

  Introducer, Catheter
  1 report

Recent SureFlex Steerable Guiding Sheath adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2026Material Perforation; Detachment of Device or Device Component

  It was reported that the side-port tubing itself became detached from the sheath handle. The customer noticed the detachment during use after the sheath had been inserted into the patient, and the detached component fell onto the sterile field over the patient. Although the detachment site could not be clearly observed, it appeared that the glued portion had come off. The doctor did not mention that air contamination had occurred. The procedure was completed with a different device and no adverse event occurred. The device is expected to return for laboratory analysis.it was further reported that prior to the side port tubing detachment, no clear damage to the side port or tubing could be confirmed; however, it was reported that the glued part appeared to have come off.Additionally, it was reported that there were no known procedural factors reported that may have contributed to the malfunction. No abnormalities or damage were observed on the side port or sheath handle when the device was removed from its packaging. The issue was identified after insertion into the body, although the exact stage of the procedure is unclear. Prior to the side-port tube becoming detached, no leakage

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50218650 ↗
• MalfunctionOct 23, 2024Defective Device; Defective Device

  IT WAS REPORTED DURING A PROCEDURE, A SUREFLEX STEERABLE GUIDING SHEATH WAS SELECTED FOR USE. THE DILATOR WAS FOUND TO HAVE A SMALL PIECE HANGING AT THE DISTAL TIP. THE DEFECT WAS FOUND WHEN THE SHEATH WAS BEING FLUSHED. HENCE THE DEVICE WAS REPLACED. NO PATIENT COMPLICATIONS OCCURRED. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20515333 ↗
• 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 ↗
• MalfunctionAug 23, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT A SUREFLEX STEERABLE SHEATH WAS SELECTED FOR A TRANSSEPTAL PROCEDURE. PRIOR TO SEDATION/PREPARATION, WHILE OUTSIDE OF THE PATIENT, IT WAS OBSERVED THAT THE HEMOSTATIC VALVE ON THE SHEATH WAS BROKEN. THUS, THE DEVICE WAS REPLACED WITH ANOTHER SAME MODEL SHEATH AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE IS NOT RETURNING AS DISCARDED IN FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20054000 ↗
• MalfunctionJul 31, 2024Material Perforation; Material Perforation

  IT WAS REPORTED THAT A SUREFLEX BMC STEERABLE SHEATH WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS MENTIONED THAT A RESISTANCE WAS FELT WHEN REMOVING THE NON-BOSTON SCIENTIFIC ORION CATHETER FROM THE NON-BOSTON SCIENTIFIC SL1 (8.5FR). AFTERWARDS, A RESISTANCE WAS CONSIDERABLY FELT WHEN REMOVED AFTER NON-BOSTON SCIENTIFIC ORION WAS INSERTED AND USED INTO THE SUREFLEX SHEATH. WHEN IT WAS SLOWLY PULLED OUT, IT WAS FOUND THAT THE TIP OF THE ORION SHAFT WAS BENT. WHILE OUTSIDE THE PATIENT, THE SIDE PORT OF SUREFLEX WAS NOTED TO BE DISLODGED, SO A NEW SUREFLEX WAS USED TO CONTINUE THE CASE. THE NON-BOSTON SCIENTIFIC ORION WAS NOT REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS. THE SIDE PORT FELL OUT DURING REMOVAL OF THE NON-BOSTON SCIENTIFIC ORION CATHETER AND SINCE THIS TYPE OF DAMAGE COULD LEAD TO AIR INGRESS, THE DEVICE WAS REPLACED IMMEDIATELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19877941 ↗
• MalfunctionJul 15, 2024Material Perforation; Material Perforation

  IT HAS BEEN REPORTED THAT A SUREFLEX STEERABLE GUIDING SHEATH WAS SELECTED FOR USE FOR AN ATRIAL FIBRILLATION (A FIB) ABLATION PROCEDURE. DURING THE PROCEDURE, WHILE OUTSIDE THE PATIENT, IT WAS MENTIONED THAT AFTER THE PRODUCT WAS REMOVED FROM ITS PACKAGING AND A FUNCTIONAL CHECK WAS PERFORMED, A CRACK-LIKE DAMAGE WAS NOTED ON THE SIDE PORT OF THE SHEATH. DUE TO THE POTENTIAL FOR AIR INGRESS, A NEW SHEATH WAS OPENED (DIFFERENT DEVICE, SAME MODEL), AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS (DISPOSED). NO OTHER ISSUES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19740576 ↗
• MalfunctionJul 3, 2024Flushing Problem; Detachment of Device or Device Component; Flushing Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT A SUREFLEX STEERABLE GUIDING SHEATH WAS SELECTED FOR USE FOR AN ABLATION PROCEDURE. DURING PREPARATION, WHILE THE DEVICE WAS OUTSIDE THE PATIENT, IT WAS MENTIONED THAT THE BASE OF THE FLUSHING PORT GOT SEPARATED FROM THE SHEATH HANDLE. THE FLUSHING WAS IMPOSSIBLE TO PERFORM DUE TO THE DAMAGE THAT OCCURRED. THE USER DOES NOT BELIEVE IT GOT DAMAGED DURING REMOVAL. THE DEVICE WAS REPLACED (DIFFERENT DEVICE, SAME MODEL), AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS REPORTED. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19669180 ↗
• 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 ↗
• MalfunctionApr 17, 2024Material Perforation; Material Perforation

  IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION (A FIB) ABLATION PROCEDURE, A SUREFLEX STEERABLE GUIDING SHEATH WAS SELECTED FOR USE. DURING PREPARATION, THE MEDICAL ENGINEER NOTED THERE WAS A CRACK ON THE SHEATH AFTER UNPACKING IT. THE PROCEDURE WAS COMPLETED USING ANOTHER SAME OF DEVICE. NO PATIENT COMPLICATIONS OCCURRED. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS. NO OTHER ISSUES WERE NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19127043 ↗
• MalfunctionMar 26, 2024Difficult to Insert; Material Deformation; Adverse Event Without Identified Device or Use Problem; Difficult to Insert; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING A PROCEDURE, A SUREFLEX STEERABLE GUIDING SHEATH WAS SELECTED FOR USE. DURING THE WITHDRAWAL/CLOSURE TIME OF EVENT, THE DEVICE WAS DIFFICULT TO INSERT AND GOT KINKED. A NON-BOSTON SCIENTIFIC CATHETER (JAPAN LIFELINE'S RING CATHETER LIBERO 20P 15MM) WAS INSERTED INTO THE SUREFLEX AND USED, AND WHEN AN ATTEMPT WAS MADE TO REMOVE THE RING CATHETER, IT GOT STUCK, AND IT COULD NOT BE MOVED AT ALL. HENCE, TO RESOLVE THE ISSUE, ANOTHER DEVICE WAS USED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS OCCURRED. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18977078 ↗
• MalfunctionFeb 20, 2024Leak/Splash; Defective Device; Leak/Splash; Defective Device

  IT WAS REPORTED THAT A BMC STEERABLE SHEATH (SUREFLEX) AND NRG RF NEEDLE WERE SELECTED FOR USE DURING AN ABLATION PROCEDURE. THE TIP OF THE NRG RF NEEDLE BROKE WHEN USING THE RF NEEDLE. IT PASSED THROUGH THE FORAMEN OVALE WITHOUT ENERGIZING, SO IT WAS COMPLETED WITHOUT ENERGIZING. ADDITIONALLY, WHEN USING SUREFLEX DURING PRE-MAPPING, THE HEMOSTATIC VALVE SEEMED TO FAIL OR BLOOD BEGAN TO LEAK, THUS THE DEVICE WAS REPLACED. NO PATIENT COMPLICATION WAS REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE DEVICES ARE NOT EXPECTED TO BE RETURNED FOR ANALYSIS. IT WAS FURTHER INFORMED THAT THE NRG NEEDLE WAS ABLE TO CROSS THE FORAMEN OVALE WITHOUT PERFORMING ENERGIZATION (RADIO FREQUENCY WAS NOT DELIVERED). NO ALERT OR ERROR WAS REPORTED. SINCE THE PROCEDURE WAS ABLE TO BE COMPLETED WITHOUT ENERGIZATION, RF WAS NOT DELIVERED. ADDITIONALLY, THE LEAK WAS IDENTIFIED WHEN USING SUREFLEX DURING PRE-MAPPING, BLOOD BEGAN TO LEAK FROM HEMOSTASTIC VALVE (SLOW DRIP). IT APPEARS THAT THE LEAK WAS COMING FROM THE HEMOSTATIC VALVE. NO FLUID WAS LEAKING FROM THE DISTAL OR PROXIMAL END OF THE HANDLE. BLOOD WAS NOTED LEAKING, WHICH STOPPED USING THE DEVICE (SUREFLEX). NO LEAK AIR WAS REPORTED. NO AIR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18743723 ↗
• MalfunctionFeb 7, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE TO TREAT ATRIAL FIBRILLATION (A FIB) IN LEFT ATRIUM, A SUREFLEX STEERABLE GUIDING SHEATH WAS SELECTED FOR USE. IT WAS NOTED THAT THE HEMOSTATIC VALVE CAME OFF. HENCE TO RESOLVE THE ISSUE, THE SHEATH WAS REPLACED BY ANOTHER ONE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS OCCURRED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS. IT WAS FURTHER CONFIRMED THERE WERE NO VISIBLE DAMAGE NOTED. THERE WAS NO LEAKAGE NOTED. THE BLUE PART OF THE HEMOSTASIS VALVE HAD COME OFF. NO OTHER DAMAGE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18659747 ↗
• MalfunctionJan 19, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT HAS BEEN REPORTED THAT A SUREFLEX STEERABLE GUIDING SHEATH WAS SELECTED FOR USE FOR A PULMONARY VEIN ISOLATION INDICATED FOR A CASE OF ATRIAL FLUTTER (AF). DURING THE PROCEDURE, THE PHYSICIAN MENTIONED THAT WHEN THE CATHETER WAS REMOVED FROM THE SHEATH AND FLUSHING WAS ATTEMPTED, A PIECE OF THE SIDEPORT BROKE OFF AND THE SIDEPORT TUBE BECAME SEPARATED FROM THE HANDLE. THE EVENT OCCURRED OUTSIDE OF THE PATIENT AND NO PATIENT COMPLICATIONS REPORTED. PROCEDURE COMPLETED SUCCESSFULLY USING A DIFFERENT DEVICE, SAME MODEL. PRODUCT IS EXPECTED TO RETURN FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18547023 ↗
• InjuryDec 14, 2023Flushing Problem; Flushing Problem

  IT WAS REPORTED THE PATIENT STROKES OCCURRED. DURING AN ABLATION PROCEDURE, A SUREFLEX STEERABLE GUIDING SHEATH WAS SELECTED FOR USE. THE SHEATH WAS PREPARED AND THEN INTRODUCED INTO THE LEFT ATRIUM. THE SHEATH WAS ASPIRATED TO PREVENT BUBBLES. ONCE THE DEVICE WERE CONNECTED WITH A NON-BOSTON SCIENTIFIC MAPPING CATHETER AND ABLATING DEVICE, ABLATION WAS PERFORMED AND THE CATHETER WAS PULLED OUT FROM THE SHEATH. AT THIS POINT WHEN THE PHYSICIAN TRIED TO ASPIRATE, A RESISTANCE WAS FELT. THE PHYSICIAN IMMEDIATELY STOPPED THE PROCEDURE AND PULLED THE SHEATH OUT. OUTSIDE THE PATIENT BODY, THE SHEATH WAS FLUSHED BUT THERE WAS NO BLOOD COAGULUM. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS. THE SHEATH WAS FLUSHED/ASPIRATED WITHOUT ANYTHING IN IT, IT WAS AFTER GETTING THE ABLATION CATHETER OUT OF THE SHEATH IT COULDN'T BE ASPIRATED. NO DAMAGES OR ISSUES NOTED WITH THE STOPCOCK. AFTER GETTING THE SHEATH OUT THERE WERE NOTHING ON THE TIP. THE "LITTLE STROKES" WERE SLOWLY TRANSIENT AND THE PATIENT SEEM TO BE RECOVER.

  Patient problems: Transient Ischemic Attack

  MAUDE report 18325795 ↗
• MalfunctionNov 6, 2023Material Fragmentation; Defective Device; Material Fragmentation; Defective Device

  IT WAS REPORTED THAT A BMC STEERABLE SHEATH WAS SELECTED FOR USE DURING AN ABLATION. DURING PREPARATION, WHILE THE DEVICE WAS OUTSIDE THE PATIENT, THE HEMOSTATIC VALVE AT THE PROXIMAL END OF THE HUB CAME OFF (IN TWO PIECES). THE SURGEON REATTACHED IT AND THE PROCEDURE WAS COMPLETED. NO LEAK WAS OBSERVED. DURING THE FLUSHING, THE TUBING DID NOT FELL OFF, NOR RESISTANCE WAS EXPERIENCED. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18081394 ↗

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