SELECTSITE™ C304-HIS (UDI 00763000147006)Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00763000147006), received between Aug 5, 2019 and Dec 9, 2021 — classified as 28 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (15 reports).

1 other recall cover devices cleared under the same FDA submission (K183493); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 9, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE WHILE SLITTING THE CATHETER THE SLITTER CAME OFF THE CATHETER. AN IRIS SCISSORS WAS USED TO COMPLETE THE REMOVAL OF THE CATHETER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12968376 ↗
• MalfunctionAug 4, 2021Accessory Incompatible; Material Integrity Problem; Accessory Incompatible; Material Integrity Problem

  IT WAS REPORTED THAT THERE WAS DIFFICULTY SLITTING THE DELIVERY CATHETER AND IT COULD NOT BE SMOOTHLY SLIT, RESULTING IN LEAD DISLODGEMENT. A SECOND CATHETER WAS UTILIZED WITH THE SAME DIFFICULTY EXCEPT THERE WAS NO DISLODGEMENT. THE CATHETER APPEARED TO BE DAMAGED AS THE INNER CORE WIRE WAS EXPOSED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12274392 ↗
• MalfunctionAug 4, 2021Break; Material Integrity Problem; Break; Material Integrity Problem

  IT WAS REPORTED THAT THERE WAS DIFFICULTY SLITTING THE DELIVERY CATHETER AND IT COULD NOT BE SMOOTHLY SLIT, RESULTING IN LEAD DISLODGEMENT. A SECOND CATHETER WAS UTILIZED WITH THE SAME DIFFICULTY EXCEPT THERE WAS NO DISLODGEMENT. THE CATHETER APPEARED TO BE DAMAGED AS THE INNER CORE WIRE WAS EXPOSED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12274389 ↗
• MalfunctionDec 7, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE IT TOOK A LOT OF FORCE TO SLIT THE CATHETER. IT WAS ADDITIONALLY NOTED THAT THE WIRE CAME OUT OF THE SHEATH AND WAS EXPOSED. THE CATHETER WAS USED TO COMPLETE THE IMPLANT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10959772 ↗
• MalfunctionDec 7, 2020Break; Break

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, AFTER PLACING THE LEAD, THE PHYSICIAN WENT TO RELEASE THE CURVE IN THE CATHETER AND THE HANDLE BROKE IN TWO. THE PHYSICIAN WAS NOT ABLE TO RELEASE THE CURVE IN THE CATHETER PRIOR TO SLITTING. THE CATHETER WAS SLIT WHILE CURVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10958654 ↗
• MalfunctionNov 17, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, PRIOR TO USE AND STILL IN THE BOX, THE CATHETER VALVE WAS FOUND TO BE BROKEN IN TWO PIECES. THE CATHETER WAS NOT USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10851918 ↗
• MalfunctionOct 8, 2020Break; Break

  IT WAS REPORTED THAT DURING SLITTING OF THE GUIDE CATHETER, APPROXIMATELY 1.5 INCHES OF THE SHEATH DISTAL END BROKE OFF, AND REMAINED AROUND THE LEAD. THE BROKEN SHEATH PORTION HAD TO BE CUT OFF OF THE LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10650873 ↗
• MalfunctionOct 8, 2020Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE HUB APPEARED TO BE CRACKED ON TWO CATHETERS WHEN THE PACKAGE WAS OPENED. THE CATHETERS WERE NOT USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10649184 ↗
• MalfunctionOct 8, 2020Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE HUB APPEARED TO BE CRACKED ON TWO CATHETERS WHEN THE PACKAGE WAS OPENED. THE CATHETERS WERE NOT USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10649173 ↗
• MalfunctionOct 2, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, THE PHYSICIAN HAD DIFFICULTY SLITTING THE DISTAL PORTION OF THE DELIVERY CATHETER AND HAD TO CUT THE LAST PORTION WITH SCISSORS. THE DELIVERY CATHETER WAS REMOVED SUCCESSFULLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10619890 ↗
• MalfunctionSep 28, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE PHYSICIAN COMPLAINED THAT THE CATHETER DID NOT SLIT WELL ESPECIALLY AT THE END OF THE CATHETER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10593211 ↗
• MalfunctionSep 21, 2020Break; Break

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE PULL WIRE WAS EXPOSED OUTSIDE OF THE SHEATH AFTER SLITTING. THE LEAD WAS IMPLANTED AND THE SHEATH WAS REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10560287 ↗
• MalfunctionSep 16, 2020Break; Break

  IT WAS REPORTED THAT WHEN THE CATHETER WAS BEING PREPARED FOR USE, IT WAS OBSERVED THAT THE VALVE ON THE END OF THE CATHETER WAS COMPLETELY CRACKED AND BROKEN OFF. THE CATHETER WAS NOT USED AND REPLACED WITH A NEW, UNDAMAGED CATHETER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10542138 ↗
• MalfunctionMay 7, 2020Break; Mechanical Problem; Break; Mechanical Problem

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE THE CATHETER WAS DIFFICULT TO SLIT AND THE CORE WIRE WAS EXPOSED. THE CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10033486 ↗
• MalfunctionJan 23, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE WHILE SLITTING THE DELIVERY CATHETER, THE SLITTER GOT CAUGHT ON A "METAL RING" APPROXIMATELY TWO INCHES FROM THE DISTAL TIP 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 9623138 ↗
• MalfunctionDec 23, 2019Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING IMPLANT, WHILE THE PHYSICIAN WAS SLITTING, RESISTANCE WAS NOTED TOWARD THE DISTAL END AND THE SLITTER CAME OUT OF THE CATHETER. THE PHYSICIAN REINSERTED THE SLITTER AND TRIED AGAIN TO MOVE PAST THIS POINT. THERE WAS STILL RESISTANCE TO THE SLITTER UNTIL A ¿POP¿ SOUND WAS HEARD AS THE SLITTER ADVANCED SLIGHTLY AND FELL OUT OF THE CATHETER AGAIN. UPON REINSERTING THE SLITTER, A WIRE WAS NOTICED TO BE HANGING OUT OF THE CATHETER. ONCE THE PHYSICIAN REINSERTED THE SLITTER AND THEY WERE WAS ABLE TO FINISH SLITTING WITHOUT TROUBLE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9513219 ↗
• MalfunctionNov 27, 2019Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING IMPLANT THE PHYSICIAN WAS UNABLE TO COMPLETE SLITTING OF THE CATHETER WITH THE SLITTER DUE TO THE CABLE IN THE SHEATH. THE SLITTING HAD TO BE COMPLETED BY CUTTING WITH THE IRIS SCISSORS. 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 9385294 ↗
• MalfunctionOct 30, 2019Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A LEAD IMPLANT PROCEDURE, THE PHYSICIAN EXPERIENCED EXTREME DIFFICULTY SLITTING THROUGH THE CATHETER. THE SLITTING WAS COMPLETED 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 9257154 ↗
• MalfunctionOct 28, 2019Deformation Due to Compressive Stress; Material Integrity Problem; Deformation Due to Compressive Stress; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT DURING SLITTING, THE CATHETER KINKED ABOUT MIDWAY. THE PHYSICIAN HAD TO USE EXTREME FORCE TO COMPLETE THE SLITTING. THE PHYSICIAN COMPLAINED ABOUT THE SLITTER GETTING STUCK ON THE BRAIDING. AFTER SLITTING, THE LEAD DISLODGED AND A NEW CATHETER WAS USED TO REPOSITION THE LEAD AND THAT CATHETER WAS SLIT WITH NO ISSUES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9246442 ↗
• MalfunctionOct 15, 2019Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING IMPLANT, THE PHYSICIAN WAS UNABLE TO SLIT THE CATHETER COMPLETELY AND GOT STUCK NEAR THE DISTAL TIP. THE CATHETER WAS SLIT THE REST OF THE WAY WITH SCISSORS AND A COPPER PIECE WAS SEEN AT THE DISTAL TIP WHERE THE PHYSICIAN GOT STUCK DURING SLITTING. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9194477 ↗
• MalfunctionOct 15, 2019Break; Break

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE WHILE SLITTING THE DELIVERY CATHETER, THE "BRAIDS WERE VISIBLE COMING OUT OF THE SIDE OF THE SLIT." THE DELIVERY 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 9192559 ↗
• MalfunctionSep 17, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT PRIOR TO USE, THE CATHETER WAS DEFLECTED AND THEN UN-DEFLECTED TO TEST IT'S CURVE. DURING THE TEST, THE BLACK DEFLECTION HANDLE SPLIT AND IT COULD NOT BE PLACED BACK ONTO THE CATHETER. THE CATHETER WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9077649 ↗
• MalfunctionAug 22, 2019Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING IMPLANT THE PHYSICIAN USED AN ADJUSTABLE SLITTER TO SLIT THE CATHETER. WHILE THE PHYSICIAN WAS SLITTING THE CATHETER, THE SLITTER GOT CAUGHT MID-WAY ON THE CATHETER AND WAS NOT ABLE TO ADVANCE FORWARD. THE PHYSICIAN HAD TO USE EXCESSIVE FORCE IN ORDER TO FINISH SLITTING AND COMPLETELY SLIT 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 8921151 ↗
• MalfunctionAug 13, 2019Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THAT THE PHYSICIAN HAD DIFFICULTY SLITTING WITH THE SLITTER THROUGHOUT THE PROXIMAL PLASTIC HUB PORTION OF THE SHEATH. IT WAS NOTED THAT DURING THE SLITTING PROCESS, THE INSULATION OF THE RIGHT VENTRICULAR (RV) LEAD WAS DAMAGED. THE CATHETER AND THE LEAD WERE REMOVED AND A REPLACEMENT RV LEAD WAS IMPLANTED SUCCESSFULLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8889426 ↗
• MalfunctionAug 13, 2019Material Integrity Problem; Material Integrity Problem

  THE PATIENT IS A PARTICIPANT IN THE POST APPROVAL CLINICAL SURVEILLANCE PRODUCT SURVEILLANCE REGISTRY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8889158 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K183493. One submission often covers many models, so check the product and lot details in each record.

• Z-1206-2022 · Apr 20, 2022 · Open, Classified
  The C304-HIS device features a guide wire to access the vein, a valve to reduce blood loss during the implant procedure, a deflectable catheter to introduce a transvenous device, a