SELECTSITE™ C304-HIS (UDI 00763000147013)Recalls & reported problems

Summary

The FDA's MAUDE database contains 62 adverse event reports that list this exact device (DI 00763000147013), received between Jun 9, 2021 and Jun 5, 2026 — classified as 6 injuries, 56 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (34 reports).

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Apr 20, 2022Open, Classified

   The firm's internal processes identified that certain lots may have an improperly sealed barrier that could potentially compromise sterility.

   Z-1206-2022 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 62 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 5, 2026Break; Detachment of Device or Device Component

  IT WAS REPORTED INTRAOPERATIVELY THAT THE CATHETER RIPPED DURING SLITTING AND WAS REMOVED IN THREE PIECES. THE CATHETER WAS ATTEMPTED/NOT USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25404842 ↗
• MalfunctionApr 3, 2026Material Integrity Problem

  IT WAS REPORTED THAT WHILE ATTEMPTING TO INSERT THE LEAD, WHEN THE PHYSICIAN WAS SLITTING THE CATHETER, THEY MENTIONED THAT THE SLITTER KEPT GETTING STUCK ON SOMETHING METAL IN THE SHEATH, NEAR THE DISTAL END OF THE SHEATH AND SAID IT LOOKED LIKE A WIRE FROM INSIDE THE BRAIDING OF THE SHEATH THAT LOOKED METAL. A SCISSORS WAS USED TO CUT THE REMAINING SHEATH AWAY FROM THE LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24774429 ↗
• MalfunctionMar 9, 2026Material Integrity Problem

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE THE RIGHT VENTRICULAR (RV) LEAD WAS KINKED DURING CATHETER SLITTING. IT WAS NOTED THAT THE PULL WIRE BECAME EXPOSED CAUSING THE SLITTER TO JUMP OFF TRACK AND KINK THE LEAD. THE RV LEAD WAS REMOVED AND REPLACED WITH A NEW LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24550633 ↗
• MalfunctionDec 2, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED DURING IMPLANT OF THE LEFT BUNDLE BRANCH LEAD THAT THE DELIVERY CATHETER FAILED TO SLIT. THE SLITTER CAUGHT THE PULL WIRE DURING SLITTING AND PREVENTED COMPLETION OF SLITTING. THE SLITTING PROCEDURE BEGAN BY STARTING THE SLIT, AND THEN REGRIPPING TO SLIT THE REMAINING CATHETER LENGTH. SLITTING BECAME DIFFICULT IN THE FIRST HALF OF THE CATHETER. FORCE WAS INCREASED AND SLITTING WAS ABLE TO JUMP FORWARD A FEW MORE TIMES UNTIL SLITTING STOPPED COMPLETELY NEAR THE TIP OF THE CATHETER. REMAINING CATHETER LEFT ON THE LEAD WAS REMOVED WITH SCISSORS. LEAD WAS INSPECTED FOR KINKING AND NO SIGNIFICANT DEFORMATION WAS SEEN. THE CATHETER AND SLITTER WERE ATTEMPTED/NOT USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23690883 ↗
• InjuryNov 21, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING IMPLANT AS THE CATHETER WAS PLACED IN THE RIGHT VENTRICULAR APEX AFTER MINIMAL MANIPULATION, THE PATIENT WENT INTO VENTRICULAR TACHYCARDIA, REQUIRING MULTIPLE ROUNDS OF SHOCK AND THE PATIENT CODING. AFTER THE CODE, THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU). THE CATHETER WAS ATTEMPTED AND NOT USED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cardiac Arrest; Tachycardia

  MAUDE report 23616920 ↗
• InjuryNov 10, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE PATIENT DESTABILIZED. IT WAS FURTHER REPORTED THAT THE PATIENT BEGAN THE CASE WITH AN AMERICAN SOCIETY OF ANESTHESIOLOGISTS (ASA) PHYSICAL STATUS CLASSIFICATION SYSTEM LEVEL OF FOUR. THE PATIENT EXPERIENCED ECTOPY WHEN THE RV LEAD WAS PASSED THROUGH THE TRICUSPID VALVE AND PLACED IN THE RIGHT VENTRICLE. CANNULATION OF THE CORONARY SINUS WAS ATTEMPTED BUT THE CLINICIAN WAS UNABLE TO CANNULATE, SO THE CLINICIAN DECIDED TO PLACE A LEFT BUNDLE BRANCH (LBB) LEAD IN THE RV. WHILE PASSING A CATHETER THROUGH THE TRICUSPID VALVE, THE PATIENT WENT INTO SUSTAINED VENTRICULAR TACHYCARDIA (VT) REQUIRING CARDIOVERSION. THE LBB LEAD HAD NOT YET BEEN INSERTED INTO THE CATHETER. THE PATIENT'S BLOOD PRESSURE DROPPED, SO THE IMPLANTING PHYSICIAN DECIDED TO END THE CASE. THE RIGHT VENTRICULAR (RV) LEAD AND CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WERE IMPLANTED AND THE PROCEDURE WAS STOPPED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Ectopic Heartbeat; Tachycardia

  MAUDE report 23512823 ↗
• MalfunctionNov 5, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING IMPLANT, THERE WERE DIFFICULTIES SLITTING THE DELIVERY CATHETER. IT WAS NOTED THAT THE WIRE IN THE DEFLECTION MECHANISM OF THE DELIVERY CATHETER WAS CAUGHT IN THE SLITTER WHICH RESULTED IN THE TIP OF THE DELIVERY CATHETER BEING UNABLE TO BE CUT. THE DELIVERY CATHETER WAS CUT, REMOVED, THEN REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23477594 ↗
• MalfunctionAug 12, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING IMPLANT, THE DISTAL PART OF THE SHEATH WAS DIFFICULT TO SLIT. IRIS SCISSORS WERE USED TO SLIT THE CATHETER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22781445 ↗
• MalfunctionAug 11, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING IMPLANT, WHEN SLITTING THE CATHETER THE SLITTER GOT STUCK. THE SLITTER WAS REMOVED AND SURGICAL TOOLS WERE USED TO FINISH SLITTING THE SHEATH. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22769228 ↗
• MalfunctionAug 11, 2025Accessory Incompatible; Accessory Incompatible

  IT WAS REPORTED THAT INTRA OPERATIVELY DURING THE PLACEMENT OF THE LEAD, THE SLITTING OF THE DELIVERY CATHETER RESULTED IN LEAD BEING PULLED OUT OF POSITION. THE DELIVERY CATHETER WAS ATTEMPTED NOT USED AND REPLACED WHICH WAS USED TO EVENTUALLY PLACE THE LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE PATIENT IS A PARTICIPANT IN THE POST APPROVAL CLINICAL SURVEILLANCE PRODUCT SURVEILLANCE REGISTRY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22768721 ↗
• MalfunctionJun 17, 2025Deformation Due to Compressive Stress; Material Integrity Problem; Deformation Due to Compressive Stress; Material Integrity Problem

  IT WAS FURTHER REPORTED THAT THERE WAS NO PERFORMANCE ISSUE WITH THE LEAD. THE ISSUE OCCURRED DURING SLITTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22235627 ↗
• MalfunctionMay 27, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT WHILE IN TRANSIT THE PACKAGING OF A DELIVERY CATHETER WAS DAMAGED. THE STERILITY OF THE PRODUCT COULD NOT BE VERIFIED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22087027 ↗
• MalfunctionMay 26, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT AFTER SLITTING THE CATHETER THE PHYSICIAN NOTICED THAT SOME OF THE CATHETER PLASTIC WAS STILL LEFT AROUND THE LEAD DURING THE IMPLANT PROCEDURE. IT WAS ALSO NOTED THAT THERE WAS ALSO A METAL RING THAT WAS LEFT AROUND THE LEAD. THE PHYSICIAN USED FORCEPS AND A SCALPEL TO CUT AWAY THE PLASTIC AND THE METAL PIECE. THERE WAS NO DAMAGE TO THE LEAD AND IT WAS SUCCESSFULLY IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22084112 ↗
• MalfunctionApr 1, 2025Break; Material Integrity Problem; Break; Material Integrity Problem

  IT WAS REPORTED THAT DURING PROCEDURE, WHEN SLITTING CATHETER HALF WAY DOWN RESISTANCE WAS FELT AND UNABLE TO CONTINUE SLITTING. THE CATHETER WAS RE ENGAGED AND CONTINUED SLITTING. IT WAS NOTICED ALL THE INTERNAL MECHANISM FOR CATHETER DEFLECT WERE OUTSIDE. THE CATHETER WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21738041 ↗
• MalfunctionMar 27, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING IMPLANT, THE CATHETER SHEATH EXHIBITED DIFFICULTY BEING SLIT, THE MATERIAL COULD NOT BE SLIT THROUGH. AN IRIS SCISSORS WAS USED TO SLIT THE SHEATH SHEATH. THE CATHETER WAS NOT USED AND WAS NOT REPLACED BY ANOTHER CATHETER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21705992 ↗
• MalfunctionMar 26, 2025Break; Material Integrity Problem; Break; Material Integrity Problem

  IT WAS FURTHER REPORTED THAT THE CATHETER HUB BROKE SMOOTHLY AND THE CABLES THAT MAKE THE CATHETER BEND BECAME CAUGHT IN THE SLITTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21698728 ↗
• MalfunctionMar 26, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE PACING LEAD KINKED AFTER SLITTING THE DELIVERY CATHETER. THE PACING LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21695840 ↗
• MalfunctionMar 13, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT INTRA OPERATIVELY DURING THE PLACEMENT OF THE RIGHT VENTRICULAR LEFT BUNDLE BRANCH (RV-LBB) LEAD, THE SLITTING OF THE CATHETER RESULTED IN LEAD DAMAGE. THE LEAD AND CATHETER WERE ATTEMPTED NOT USED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21592336 ↗
• InjuryFeb 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING IMPLANT, THE CATHETER AND LEAD WERE REPOSITIONED AS THE SEPTUM WAS PERFORATED. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Perforation

  MAUDE report 21405253 ↗
• MalfunctionFeb 18, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE DELIVERY CATHETER DID NOT PROVIDE ENOUGH SUPPORT TO REACH INTENDED IMPLANT SITE. THE CATHETER WAS ATTEMPTED, NOT USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21400631 ↗
• MalfunctionFeb 18, 2025Detachment of Device or Device Component; Material Integrity Problem; Detachment of Device or Device Component; Material Integrity Problem

  IT WAS REPORTED THAT INTRA-OPERATIVE IT WAS DIFFICULT TO SLIT THE GUIDE CATHETER. SLITTING FUNCTION WAS IMPEDED BY WIRES AND A METAL ITEM FROM THE CATHETER. THE CATHETER WAS CUT AWAY WITH SCISSORS AND FORCEPS AND A METAL PIECE REMAINED AROUND THE PACING LEAD. THE METAL RING WAS CUT OFF WITH SCISSORS AS WELL. THE CATHETER WAS REMOVED. LEAD FUNCTION WAS WITHIN NORMAL LIMITS AFTER THIS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21395834 ↗
• MalfunctionFeb 11, 2025Break; Appropriate Device Problem Term/Code Not Available; Break; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING THE USE OF A CATHETER C304-HIS, WIRES BECAME EXPOSED AND BOUND UP AT THE DISTAL END WHILE SLITTING WITH AN ADJUSTABLE SLITTER. THE SLITTER BECAME JAMMED IN THE SHEATH, AND METAL WIRES WERE EXPOSED FROM THE INNER CORE OF THE SHEATH. THESLITTER HAD TO BE DISENGAGED AND RE-ENGAGED TO AVOID BINDING WITH THE EXPOSED WIRES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21353608 ↗
• MalfunctionFeb 10, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT INTRA-OPERATIVE THE THE GUIDE CATHETER WAS SLIT AND THE INTERNAL WIRE OF THE CATHETER WRAPPED AROUND THE HIS BUNDLE LEAD AND DISLODGED IT FROM THE PATIENT, AND ALSO APPARENTLY DAMAGED THE LEAD. A PROXIMAL STIFFNESS OF THE CATHETER WAS NOTED NEAR THE HUB, WHERE THE WIRE/LEAD HAD AN INTERACTION AND IS SUSPECTED TO HAVE CAUSED LEAD DISLODGEMENT, HIGH HIS LEAD IMPEDANCE AND NO CAPTURE. THE LEAD WAS ATTEMPTED/NOT USED AND WAS REPLACED. THE CATHETER WAS REPLACED. IT WAS REPORTED THAT THE SECOND CATHETER EXHIBITED A SLITTING ISSUE, AND PART OF WIRE OF THE CATHETER WAS STUCK IN THE SLITTER. SLITTING WAS COMPLETED WITH ANOTHER PRODUCT. IT WAS NOTED THAT THE SECOND CATHETER WAS NOT BENT BENT, AND WIRE USED TO FLEX THE CATHETER WAS STRAIGHT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21343070 ↗
• MalfunctionFeb 10, 2025Accessory Incompatible; Material Deformation; Accessory Incompatible; Material Deformation

  IT WAS REPORTED THAT INTRA-OPERATIVE THE GUIDE CATHETER WAS SLIT AND THE INTERNAL WIRE OF THE CATHETER WRAPPED AROUND THE HIS BUNDLE LEAD AND DISLODGED IT FROM THE PATIENT, AND ALSO APPARENTLY DAMAGED THE LEAD. A PROXIMAL STIFFNESS OF THE CATHETER WAS NOTED NEAR THE HUB, WHERE THE WIRE/LEAD HAD AN INTERACTION AND IS SUSPECTED TO HAVE CAUSED LEAD DISLODGEMENT, HIGH HIS LEAD IMPEDANCE AND NO CAPTURE. THE LEAD WAS ATTEMPTED/NOT USED AND WAS REPLACED. THE CATHETER WAS REPLACED. IT WAS REPORTED THAT THE SECOND CATHETER EXHIBITED A SLITTING ISSUE, AND PART OF WIRE OF THE CATHETER WAS STUCK IN THE SLITTER. SLITTING WAS COMPLETED WITH ANOTHER PRODUCT. IT WAS NOTED THAT THE SECOND CATHETER WAS NOT BENT, AND WIRE USED TO FLEX THE CATHETER WAS STRAIGHT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21343051 ↗
• InjuryJan 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE PATIENT EXPERIENCED LEFT BUNDLE BRANCH (LBB) INJURY WITH COMPLETE HEART BLOCK (CHB) DURING THE USE OF THE DELIVERY CATHETER. TEMPORARY RIGHT VENTRICULAR (RV) LEAD PACING WAS REQUIRED DURING IMPLANT. THE CATHETER WAS REMOVED. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Heart Block; Non specific EKG/ECG Changes

  MAUDE report 21103904 ↗