NA C315S1002Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000160203), received between Apr 21, 2021 and Aug 31, 2026 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (2 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.

• MalfunctionAug 31, 2026Break; Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50522072 ↗
• InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE THE RIGHT VENTRICULAR (RV) LEAD AND CATHETER PERFORATED THE SEPTUM. THE RV LEAD AND CATHETER WERE REMOVED. THE LEAD WAS REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Perforation

  MAUDE report 24643097 ↗
• MalfunctionJan 19, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN THE PHYSICIAN STARTED TO CUT THE DELIVERY CATHETER AND PULL THE WHITE HANDLE, THE WHITE HANDLE BROKE AND DETACHED FROM CATHETER. THE CATHETER WAS REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18548491 ↗
• MalfunctionAug 2, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN ATTEMPTED IMPLANT SLITTING WAS UNSUCCESSFUL WHILE THE CATHETER WAS IN THE ATRIUM. THE CATHETER WAS REMOVED. 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 15147154 ↗
• MalfunctionApr 21, 2021Accessory Incompatible; Accessory Incompatible

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE CATHETER WAS UNABLE TO FOLLOW THE TOP OF THE HUB. THE CATHETER HUB GRABBED AND DISLODGED THE RIGHT VENTRICULAR (RV) LEAD DURING SLITTING. THE SLITTER DID NOT CUT THROUGH THE SEAL. THE CATHETER WAS REMOVED AND REPLACED. THE RV LEAD WAS ULTIMATELY IMPLANTED AND REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11704286 ↗