NA C315S502Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00763000160227), received between Aug 23, 2021 and Mar 13, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2026Accessory Incompatible

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THERE WAS A SLITTING ISSUE WHICH RESULTED IN LEAD DISLODGING DURING IMPLANT. THE PATIENT IS A PARTICIPANT IN THE POST APPROVAL CLINICAL SURVEILLANCE PRODUCT SURVEILLANCE REGISTRY. THE LEAD REMAINS IN USE AND ANOTHER CATHETER WAS USED TO IMPLANT THE LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24589842 ↗
• MalfunctionDec 12, 2025Accessory Incompatible; Break; Material Integrity Problem; Accessory Incompatible; Break; Material Integrity Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PACING LEAD (IPL) WAS PLACED AS NEEDED AND DURING THE DELIVERY CATHETER SLITTING PROCESS, THE CUT WAS NOT SMOOTH AND DAMAGE OCCURRED MIDWAY. THE IPL WAS NOTED TO HAVE DISLODGED DURING THE DELIVERY CATHETER SLITTING. A NEW DELIVERY CATHETER, AND SLITTER WAS USED TO IMPLANT 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 23791375 ↗
• MalfunctionNov 14, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE CATHETERS  EXPERIENCED SLITTING DIFFICULTIES, WAS KINKED AND OBSTRUCTED LEADING TO LEAD PLACEMENT DIFFICULTY.  THE CATHETERS WERE REPLACED IMPLANTATION OF THE LEAD WAS SUCCESSFULLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23562720 ↗
• MalfunctionJun 16, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT INTRA OPERATIVELY DURING THE PLACEMENT OF THE RIGHT ATRIAL (RA) LEAD, THRESHOLD INCREASE WAS NOTED AFTER SLITTING OF THE DELIVERY CATHETER. THE LEAD AND DELIVERY CATHETER 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 22209896 ↗
• MalfunctionMay 12, 2025Break; Break

  IT WAS REPORTED THAT THE CATHETERS ONE WAY VALVE DISLODGED INTO THE SHAFT OF THE CATHETER WHEN ATTEMPTING TO PLACE THE DILATOR INTO THE CATHETER WHILST PREPARING THE CATHETER. THE CATHETER AND DILATOR WERE REMOVED FROM THE STERILE TABLE AND A NEW DELIVERY CATHETER WAS PROVIDED. THE CATHETER WAS ATTEMPTED NOT USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22000515 ↗
• MalfunctionAug 18, 2023Break; Break

  IT WAS REPORTED THAT THE DELIVERY CATHETER VALVE WHICH PREVENTS BACKFLOW OF BLOOD BECAME STUCK ON THE DILATOR WHEN REMOVING THE DILATOR FROM THE CATHETER AND LEAKING WAS OBSERVED. THE VALVE WAS PULLED OUT OF THE CATHETER HUB WHEN THE DILATOR WAS FULLY REMOVED FROM THE CATHETER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17575764 ↗
• MalfunctionAug 23, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING RIGHT ATRIAL (RA) LEAD IMPLANT, THE SEAL ON THE CATHETER DID NOT SLIT PROPERLY. AS A RESULT, THE SEAL "CAUGHT" THE ATRIAL LEAD AND PULLED IT OUT OF PLACE. A NEW CATHETER AND LEAD WERE USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12353827 ↗