SELECTSITE™ C304L6906Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00613994729774), received between Oct 6, 2017 and Oct 30, 2024 — classified as 5 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (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, 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryOct 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT THE EXTRACTION OF THE DEVICE PROCEDURE WAS DUE TO A HEART INFECTION.

  Patient problems: Endocarditis; Fever; Sepsis; Unspecified Infection

  MAUDE report 20569157 ↗
• MalfunctionOct 9, 2024Accessory Incompatible; Deformation Due to Compressive Stress; Accessory Incompatible; Deformation Due to Compressive Stress

  IT WAS FURTHER REPORTED THAT THE SECOND CATHETER THAT WAS USED DURING THE PROCEDURE WAS KINKED MAKING IT DIFFICULT TO REMOVE THE SHEATH AND CUT IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20410140 ↗
• InjurySep 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING IMPLANT, THE DELIVERY CATHETER PERFORATED THE CORONARY SINUS DURING LEAD REPOSITIONING AND THE PATIENT DEVELOPED A PERICARDIAL HEMATOMA. THE PATIENT WAS HEMODYNAMICALLY STABLE. THE PATIENT WAS TREATED WITH INTRAVENOUS ANTIBIOTICS AND AN ERYTHROPOIESIS-STIMULATING AGENT. THE PATIENT WAS HOSPITALIZED FOR AN EXTENDED PERIOD OF TIME. THE ISSUE RESOLVED AFTER THREE WEEKS. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Hematoma; Perforation of Vessels

  MAUDE report 15385274 ↗
• InjuryAug 23, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED IATROGENIC ATRIOVENTRICULAR NODE BLOCK DURING LEFT VENTRICULAR (LV) LEAD PLACEMENT. THERE WAS A PAUSE DURING CANNULATION DUE TO AV BLOCK WHICH REQUIRED MEDICATION TREATMENT. THE LEAD IS STILL IN USE. 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 15279007 ↗
• MalfunctionJul 26, 2022Accessory Incompatible; Accessory Incompatible

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE THE HIS LEAD DISLODGED DURING CATHETER SLITTING. THE CATHETER WAS REPLACED WITH A DIFFERENT MODEL OF CATHETER AND THE LEAD WAS IMPLANTED SUCCESSFULLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15106387 ↗
• MalfunctionApr 13, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A SLITTING ISSUE WAS ENCOUNTERED WITH THE MEDIAL ONE THIRD OF THE DELIVERY CATHETER. THE DEFLECTABLE WIRE BECAME STUCK IN THE CUTTING BLADE, MAKING IT DIFFICULT TO SLIT THE CATHETER WITHOUT DISLODGING THE LEAD. A SLITTING ISSUE WAS ENCOUNTERED WITH THE MEDIAL OR DISTAL ONE THIRD OF A SECOND DELIVERY CATHETER. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14104062 ↗
• MalfunctionApr 13, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A SLITTING ISSUE WAS ENCOUNTERED WITH THE MEDIAL ONE THIRD OF THE DELIVERY CATHETER. THE DEFLECTABLE WIRE BECAME STUCK IN THE CUTTING BLADE, MAKING IT DIFFICULT TO SLIT THE CATHETER WITHOUT DISLODGING THE LEAD. A SLITTING ISSUE WAS ENCOUNTERED WITH THE MEDIAL OR DISTAL ONE THIRD OF A SECOND DELIVERY CATHETER. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14104061 ↗
• MalfunctionApr 13, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A SLITTING ISSUE WAS ENCOUNTERED WITH THE MEDIAL ONE THIRD OF THE DELIVERY CATHETER. THE DEFLECTABLE WIRE BECAME STUCK IN THE CUTTING BLADE, MAKING IT DIFFICULT TO SLIT THE CATHETER WITHOUT DISLODGING THE LEAD. A SLITTING ISSUE WAS ENCOUNTERED WITH THE DISTAL ONE THIRD OF A SECOND DELIVERY CATHETER. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14103590 ↗
• MalfunctionApr 13, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A SLITTING ISSUE WAS ENCOUNTERED WITH THE MEDIAL ONE THIRD OF THE DELIVERY CATHETER. THE DEFLECTABLE WIRE BECAME STUCK IN THE CUTTING BLADE, MAKING IT DIFFICULT TO SLIT THE CATHETER WITHOUT DISLODGING THE LEAD. A SLITTING ISSUE WAS ENCOUNTERED WITH THE DISTAL ONE THIRD OF A SECOND DELIVERY CATHETER. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14103572 ↗
• InjuryNov 16, 2021Break; Break

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THERE WAS DIFFICULT VENOUS ACCESS. THE CEPHALIC VEIN WAS ISOLATED AND CANNULATED BUT THE VEIN WAS TO SMALL AND TORTUOUS TO ACCOMMODATE THE SHEATH. THE LEFT SUBCLAVIAN VEIN WAS THEN CANNULATED WITH DIFFICULTY USING FLUORO. THE PHYSICIAN HAD DIFFICULTY OBTAINING ACCEPTABLE PACING AND SENSING DESPITE ADEQUATE FIXATION. THE PHYSICIAN DECIDED TO CHANGE THE CATHETER AND LEAD. IT WAS FOUND THAT THE CATHETER WAS DAMAGED AND NOT THE LEAD. THEN POST PROCEDURE A SMALL LEFT SIDED PNEUMOTHORAX WAS NOTED ON FLUOROSCOPY. A CHEST TUBE WAS IMPLANT BY CARDIOTHORACIC SURGERY. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pneumothorax

  MAUDE report 12819153 ↗
• MalfunctionAug 5, 2019Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE LEAD INSULATION WAS DAMAGED BY THE BRAIDED WIRE OF THE CATHETER. THE LEAD WAS NOT IMPLANTED AND REPLACED WITH A NEW LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8861758 ↗
• MalfunctionJun 17, 2019Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE THERE WAS DIFFICULTY SPLITTING THE DELIVERY CATHETER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8705253 ↗
• MalfunctionOct 31, 2018Break; Break

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE SHEATH BROKE WHEN IT WAS USED TO DELIVER THE SHEATH. IT WAS DIFFICULT TO REACH THE REQUIRED POSITION. A DIFFERENT SHEATH WAS USED TO COMPLETE THE OPERATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8025308 ↗
• MalfunctionOct 12, 2018Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE DELIVERY CATHETER GOT CAUGHT OVER THE LEAD WHILE SLITTING. THE CATHETER HAD TO BE MANUALLY FREED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7960735 ↗
• MalfunctionOct 2, 2018Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE WIRE ASSOCIATED WITH THE INTERNAL MECHANISM OF THE DELIVERY CATHETER BECAME EXPOSED DURING THE SLITTING PROCESS AND MADE SLITTING MORE DIFFICULT FOR THE PHYSICIAN. SLITTING WAS DONE SUCCESSFULLY, AND THE CATHETER WAS REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7927726 ↗
• MalfunctionAug 24, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHILE IMPLANTING THE RIGHT VENTRICULAR (RV) LEAD THE CATHETER VALVES HAD BACK-BLEEDING. THE LEAD WAS ABLE TO BE IMPLANTED. IT WAS POST-OPERATIVELY NOTED THAT THE RV LEAD WAS OVERSENSING ATRIAL EVENTS AND UNDERSENSING R-WAVES. THE LEAD WAS RE PROGRAMMED AND NO UNDERSENSING OR OVERSENSING WAS NOTED AFTER REPROGRAMMING WAS COMPLETE. THE LEAD REMAINS IN USE. THE PATIENT IS A PARTICIPANT IN (B)(6). NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7812632 ↗
• MalfunctionApr 10, 2018Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE RIGHT VENTRICULAR (RV) LEAD REPLACEMENT, THE DELIVERY CATHETER WAS DIFFICULT TO SLIT AND HAD FIBROUS STRANDS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7414815 ↗
• MalfunctionFeb 8, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING IMPLANT, THE PHYSICIAN NOTICED THE BRAIDWIRE EXPOSED POST SLITTING OF THE CATHETER. THE CATHETER WAS REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7257814 ↗
• InjuryOct 6, 2017Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE TIP OF THE SHEATH WAS QUITE HARD AND SCRATCHED THE PATIENT'S CARDIAC MUSCLE. ANOTHER CATHETER USED WAS TOO SOFT AND THE SUPPORTING FORCE WAS INSUFFICIENT. NEITHER LEAD WAS IMPLANTED. THE OPERATION WAS THEN ABORTED FOR THE PATIENT'S SAFETY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Code Available

  MAUDE report 6920587 ↗