CPS Direct™ DS2C029Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05415067004284), received between Oct 2, 2024 and Sep 18, 2025 — classified as 2 injuries, 1 malfunction.

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

• InjurySep 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PERFORATION OCCURRED IN THE RIGHT ATRIUM WHILE MANEUVERING THE CATHETER DURING THE IMPLANT PROCEDURE. THE EVENT WAS RESOLVED WITH PERICARDIOCENTESIS, AND THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Cardiac Perforation

  MAUDE report 23084374 ↗
• InjurySep 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN IMPLANT PROCEDURE, THE PATIENT EXPERIENCED EXCESSIVE BLEEDING. IT WAS SUSPECTED THE EXCESSIVE BLEEDING WAS DUE TO MEDICATION, PATIENT FACTORS OR THE SIZE OF THE SHEATH. FURTHER INFORMATION HAS BEEN REQUESTED BUT HAS NOT YET BEEN RECEIVED. THE PATIENT WAS STABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22976825 ↗
• MalfunctionOct 2, 2024Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE CATHETER WAS DIFFICULT TO SLIT DURING THE IMPLANT PROCEDURE. AS A RESULT, THE PHYSICIAN SLIGHTLY CUT HIMSELF ON THE HAND. THE PHYSICIAN WAS IN STABLE CONDITION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 20355672 ↗