NA C315HIS02 (UDI 00763000160180)Recalls & reported problems

Summary

The FDA's MAUDE database contains 369 adverse event reports that list this exact device (DI 00763000160180), received between Dec 9, 2020 and Sep 30, 2026 — classified as 26 injuries, 343 malfunctions.

The most frequently reported specific device problem is “Break” (92 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. Sep 9, 2021Open, Classified

   Medtronic is recalling three lots of unused C315HIS Delivery Catheters due to reports of an inability to pass a lead through the catheter.

   Z-0173-2022 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 369 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Break

  The catheter was returned to the manufacturer, analyzed, and tested out of specification. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50943167 ↗
• MalfunctionSep 29, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931302 ↗
• MalfunctionSep 28, 2026Break; Material Integrity Problem

  It was reported that during implant after the pacing lead was slit, it dislodged. When attempted to re-implant, damage to the lead coating was confirmed. Damage to the catheter was also noted. The pacing lead was 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 50913897 ↗
• MalfunctionSep 24, 2026Material Integrity Problem

  It was reported that during implant the Right Atrial (RA) lead was unable to be placed with good amplitude. It was also reported that the Right Ventricular (RV) Left Bundle Branch (LBB) lead was unable to be slit as it became stuck partway through. After slitting was completed while recovering from the issue, it was confirmed that the lead insulation had been damaged. The RA lead and RV LBB leads were 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 50881329 ↗
• MalfunctionSep 21, 2026Break

  It was reported that during implant the luer hub of the catheter was not 'seated' in the catheter and appeared as though it would fall out easily. The lead 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 50839614 ↗
• MalfunctionSep 21, 2026Accessory Incompatible

  It was reported that during implant, during sheath cutting, the lead was pulled out. When attempting implantation again, the operator found that it was difficult to screw it into the myocardial tissue, and therefore believed that the tip end might be deformed. Subsequently, the lead was replaced, and implantation could be completed successfully.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50836916 ↗
• MalfunctionSep 15, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50774722 ↗
• MalfunctionSep 11, 2026Accessory Incompatible

  It was reported during Right Ventricular (RV) lead placement, while attempting to direct the delivery catheter to the target location, the proximal side at the catheter end bent and kinked, and proper manipulation and implantation became difficult. The catheter was attempted/not used and replaced. Furthermore, during slitting after ventricular lead placement, when the cutter reached the middle portion of the catheter, it did not advance smoothly, and this led to the lead being pulled and dislodgement occurring; therefore, the lead was placed again. The RV lead 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 50732610 ↗
• InjuryAug 28, 2026Leak/Splash; Adverse Event Without Identified Device or Use Problem

  It was reported that during Right Ventricular (RV) lead placement pulsating blood leakage was observed from the valve of the catheter. The RV lead was immediately withdrawn. A ventricular septal wall perforation was suspected. Imagining confirmed that no extravasation into the pericardial space was present and no tamponade had developed. The patient had no subjective symptoms. The patient's condition was monitored and implant procedure was completed. The RV lead remain in use. No patient complications have been reported as a result of this event.

  Patient problems: Perforation

  MAUDE report 50507301 ↗
• InjuryAug 27, 2026Appropriate Device Problem Term/Code Not Available

  It was reported that intra operatively during the replacement procedure, Vascular dissection was noted on the venogram when the catheter was advanced. Patient¿s hemodynamics remained stable. Therefore, the catheter was eventually used to place the lead successfully. No further patient complications have been reported as a result of this event.

  Patient problems: Vascular Dissection

  MAUDE report 50471884 ↗
• MalfunctionAug 27, 2026Break

  It was reported that during the implant procedure, catheter hemostatic valve was not working properly. Catheter was not used and was replaced but the same issue was observed with the second catheter. Second catheter was not used and was replaced. The catheters were returned to the manufacturer, analysed, and tested out of specification. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50471221 ↗
• MalfunctionAug 27, 2026Break

  It was reported that during the implant procedure, catheter hemostatic valve was not working properly. Catheter was not used and was replaced but the same issue was observed with the second catheter. Second catheter was not used and was replaced. The catheters were returned to the manufacturer, analysed, and tested out of specification. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50471190 ↗
• MalfunctionAug 25, 2026Accessory Incompatible

  It was reported that during implant the lead catheter became kinked and was replaced with a new sheath. When the second sheath was cut, the lead dislodged. Then another new sheath was unpacked for implantation, with good parameters, and the sheath was successfully removed to complete implantation. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50430616 ↗
• MalfunctionAug 25, 2026Break

  It was reported that during implant the lead catheter was bent and damaged with a valve missing. It was further reported that the Right Ventricular (RV) lead exhibited placement difficulty as well as high thresholds and high impedance. Both the lead and catheter 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 50427496 ↗
• MalfunctionAug 18, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50299507 ↗
• MalfunctionAug 13, 2026Accessory Incompatible

  It was reported intraoperatively that the pacing lead became dislodged during slitting of the catheter. A new catheter was used and the pacing lead was successfully implanted. The first 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 50233265 ↗
• MalfunctionAug 10, 2026Accessory Incompatible

  It was reported that during the implant procedure that during left branch stimulation, displacement of the hemostatic valve at the time of passage of the introducer. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50191763 ↗
• MalfunctionAug 10, 2026Accessory Incompatible

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50189948 ↗
• MalfunctionJul 30, 2026Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50093856 ↗
• MalfunctionJun 18, 2026Accessory Incompatible; Material Integrity Problem

  IT WAS REPORTED THAT DURING IMPLANT, THE LEFT VENTRICULAR (LV) LEAD WAS PLACED WITHOUT IMMEDIATE DIFFICULTY. HOWEVER, FIXATION OF THE LEAD APPEARED UNSTABLE. THE LEAD WAS REMOVED AND A SECOND LV LEAD WAS USED. IT WAS NOTED THAT MOVEMENT OF THE SECOND LV LEAD APPEARED INCONSISTENT AND AN ECHOCARDIOGRAM CONFIRMED EFFUSION. THE ABNORMAL LEAD MOVEMENT WAS ALSO NOTED AT THE TIME OF THE FIRST LV LEAD PLACEMENT ATTEMPT. THE PATIENT¿S VITAL SIGNS REMAINED STABLE. THE SECOND LV LEAD WAS IMPLANTED AND THE PROCEDURE WAS CONTINUED. THE RIGHT VENTRICULAR (RV) LEAD WAS PLACED USING A DELIVERY CATHETER. WHILE SLITTING, RESISTANCE WAS ENCOUNTERED WITH THE DELIVERY CATHETER, AND THE RV LEAD BECAME DISLODGED. THE RV LEAD AND CATHETER WERE REMOVED FROM THE PATIENT. UPON INSPECTION OF THE CATHETER, A POTENTIAL DEFECT WAS SUSPECTED AT THE SITE WHERE RESISTANCE HAD BEEN FELT. THE CATHETER WAS REPLACED AND THE RV LEAD WAS IMPLANTED WITH A NEW CATHETER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25553957 ↗
• MalfunctionJun 18, 2026Break

  IT WAS REPORTED THAT DURING IMPLANT PROCEDURE THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH IMPEDANCE WARNINGS DESPITE MULTIPLE ATTEMPTS TO CHANGE THE PACING SITE. THE LEAD WAS REPLACED. A CREASE WAS NOTICED AT THE DISTAL TIP END OF THE SHEATH. THE SHEATH WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25543908 ↗
• MalfunctionJun 12, 2026Material Integrity Problem

  IT WAS REPORTED THAT INTRA OPERATIVELY DURING THE PLACEMENT OF THE LEFT BUNDLE BRANCH LEAD, THE PHYSICIAN FAILED TO ROTATE IT INTO THE PROPER POSITION WHEN OPERATING THE 3830 LEAD DESPITE MULTIPLE ATTEMPTS. UPON REMOVING THE LEAD, EXCESSIVE CONNECTIVE TISSUE WAS OBSERVED AT ITS TIP, THEREFORE THE TISSUE WAS CLEARED, AND THE LEAD WAS RE-SECURED. THE TESTING PARAMETERS WERE NORMAL BUT AFTER THE SHEATH WAS CUT, SUBSEQUENT TESTING REVEALED CHANGES IN THE MULTI-LEAD ELECTROCARDIOGRAPHIC WAVEFORMS. A NEW CATHETER WAS USED FOR IMPLANT OF THE LEAD. SHORTLY, IT WAS DISCOVERED THAT THE HELICAL SCREW AT THE LEAD TIP HAD BECOME DEFORMED. THEREFORE, THE LEAD 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 25482300 ↗
• MalfunctionJun 9, 2026Detachment of Device or Device Component

  IT WAS REPORTED DURING IMPLANT THAT THE SEALING VALVE ON THE CATHETER DID NOT CUT AND CAME OFF WHEN SLITTING THE SHEATH. 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 25439520 ↗
• MalfunctionJun 3, 2026Use of Device Problem

  IT WAS REPORTED THAT INTRA-OPERATIVELY THE LEFT BUNDLE BRANCH (LBB) LEAD BECAME DISLODGED DURING DELIVERY CATHETER SHEATH WITHDRAWAL. THE LEAD WAS RE-IMPLANTED BUT DISLODGED AGAIN DURING A SECOND SHEATH REMOVAL. THE LEAD AND CATHETERS WERE NOT USED AND WERE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25372428 ↗
• MalfunctionMay 29, 2026Break; Mechanical Problem

  IT WAS REPORTED THAT INTRA-OPERATIVELY THE DELIVERY CATHETER FAILED TO PEEL AWAY AFTER LEAD PLACEMENT. THE CATHETER WAS NOT USED AND WAS REPLACED. IT WAS FURTHER REPORTED THAT THE CATHETER WAS RETURNED, ANALYZED AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25328577 ↗