NA C315H4002 (UDI 00613994749949)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994749949), received between Apr 21, 2022 and Apr 21, 2022 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K101885); they may or may not involve this specific model.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY ONE MONTH IMPLANT OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM, THE PATIENT EXPERIENCED PERICARDIAL EFFUSION WITH PAIN AT IMPLANT SITE. IT WAS ALSO REPORTED THAT A DURING THE IMPLANT PROCEDURE THE PATIENT ANTICOAGULATED SO POSSIBLE WITH ANTICOAGULANT FIVE ATTEMPTS IS RELATED TO THE PERICARDIAL EFFUSION. THE PATIENT WAS ADMINISTERED ORAL MEDICATION OR ADDITIONAL MEDICATION WAS GIVEN OR ADJUSTED. THE CRT-D SYSTEM REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY.

  Patient problems: Pericardial Effusion

  MAUDE report 14175764 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K101885. One submission often covers many models, so check the product and lot details in each record.

• Z-0173-2022 · Sep 9, 2021 · Open, Classified
  C315-HIS Delivery Catheter