NA C315S402Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000160210), received between May 15, 2025 and Feb 11, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Accessory Incompatible” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 11, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING IMPLANT THE PACING LEAD ENCOUNTERED PLACEMENT DIFFICULTY AND EXHIBITED HIGH THRESHOLDS. IT WAS NOTED THE SHEATH ENCOUNTERED PLACEMENT DIFFICULTY ALSO. THE PACING LEAD AND SHEATH 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 24316224 ↗
• MalfunctionDec 23, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE AFTER THE HIS LEAD WAS PLACED IN THE VENTRICLE, THE CATHETER WAS TORN, AND THE THRESHOLD INCREASED. A NEW CATHETER WAS USED TO REIMPLANT THE LEAD AND WHEN THE CATHETER WAS TORN, THE SLITTER BLADE ENCOUNTERED SIGNIFICANT RESISTANCE, THE BLADE COULD NOT SMOOTHLY CUT THE CATHETER, AND THE CATHETER WAS SCRAPPED. IT WAS ALSO NOTED THAT AFTER THE BLADE TORE THROUGH THE CATHETER SEVERAL TIMES, IT BECAME DEFORMED, AND CUTTING THROUGH THE CATHETER AGAIN FELT JERKY. THE HIS LEAD WAS THEN REMOVED AND TISSUE WAS FOUND ATTACHED TO THE TIP AND THE HELIX WAS DEFORMED. A NEW LEAD WAS IMPLANTED AND A NEW CUTTING BLADE WAS OPENED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23878607 ↗
• MalfunctionSep 3, 2025Accessory Incompatible; Accessory Incompatible

  IT WAS FURTHER REPORTED THAT THE RA LEAD REMAINS IN USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22952349 ↗
• MalfunctionSep 3, 2025Accessory Incompatible; Accessory Incompatible

  IT WAS REPORTED DURING IMPLANT OF THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM, THE RIGHT ATRIAL (RA) LEAD DISLODGED DURING SLITTING. THE LEAD WAS IMPLANTED AND REMAINS IN USE AND THE CATHETER AND SLITTER 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 22951115 ↗
• MalfunctionMay 15, 2025Accessory Incompatible; Accessory Incompatible

  IT WAS FURTHER REPORTED THAT MULTIPLE CATHETERS WERE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22025735 ↗