NA C315H4002 (UDI 00763000160173)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000160173), received between Aug 23, 2022 and Sep 14, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2022Leak/Splash; Use of Device Problem; Leak/Splash; Use of Device Problem

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE THE USER WAS DISSATISFIED WITH THE INSERTION OF THE LEAD INTO THE CATHETER VALVE. IT WAS NOTED THAT THE CATHETER VALVE WAS LEAKING BLOOD INTO THE LEAD IMPACTING THE TORQUABILITY. 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 15419533 ↗
• InjuryAug 23, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SUSTAINED VENTRICULAR TACHYCARDIA (VT) WITH REPORTED DIZZINESS, NAUSEA, AND HYPOTENSION. THE SYMPTOMS WERE SUSPECTED TO BE RELATED TO THE IMPLANT PROCEDURE WHICH THE VENTRICULAR TISSUE COULD HAVE BEEN IRRITATED POSSIBLY BY THE CATHETER. THE CATHETER WAS REMOVED. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dizziness; Low Blood Pressure/ Hypotension; Nausea; Tachycardia

  MAUDE report 15276172 ↗