SureFlex Steerable Guiding Sheath TSK0004 (REF NA)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00685447006213), received between Aug 25, 2023 and Aug 12, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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, 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

Recent adverse event reports

The 13 most recent of 13 reports, 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 ↗
• 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 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 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 ↗
• 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 ↗
• MalfunctionOct 24, 2023Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A PULMONARY VEIN ISOLATION PROCEDURE, A SUREFLEX STEERABLE GUIDING SHEATH WAS SELECTED FOR USE. DURING THE PREPARATION, THE STAFF MEMBER HAD TO TRY TO PUSH DILATOR INTO THE SHEATH AND THE HEMOSTATIC VALVE SEEMED BROKEN. HENCE TO RESOLVE THE ISSUE, A NON-BOSTON SCIENTIFIC DEVICE WAS USED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND NO PATIENT COMPLICATIONS OCCURRED. THE DEVICE IS NOT EXPECTED TO BE RETURNED. IT WAS FURTHER CONFIRMED, THE DILATOR HUB DID NOT SNAP OFF. IT WAS UNCERTAIN TO IF THE MEDICAL ENGINEER (ME) WHO WAS PREPARING DEVICES FOR THE FIRST TIME, MIGHT HAVE AFFECTED THE ISSUE TO OCCUR. THE GUIDEWIRE WAS NOT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17995789 ↗
• MalfunctionSep 25, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT HAS BEEN REPORTED THAT A SUREFLEX STEERABLE GUIDING SHEATH WAS SELECTED FOR USE FOR AN UNKNOWN PROCEDURE. IT HAS BEEN MENTIONED THAT THE USER EXPERIENCED AN ISSUE WHERE THE SHEATH WAS EXPOSED TO FOREIGN MATERIAL. NO PATIENT COMPLICATIONS REPORTED. DEVICE AND PROCEDURE OUTCOME ARE UNKNOWN. PRODUCT IS EXPECTED TO RETURN FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17813657 ↗
• MalfunctionAug 25, 2023Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CATHETER ABLATION PROCEDURE TO TREAT PAROXYSMAL EPIGASTRIC TACHYCARDIA, A SUREFLEX STEERABLE GUIDING SHEATH WAS SELECTED FOR USE. DURING INSERTION TO DRAW REVERSE BLOOD, AIR WAS NOTED. THE SHEATH WAS THEN FLUSHED AND RE-INSERTED. AIR WAS PULLED OUT THE SAME WAY. THEREFORE, TO RESOLVE THE ISSUE, THE DEVICE WAS REPLACED, 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 17625865 ↗