CPS DIRECT™ 410213Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05414734207089), received between Nov 3, 2021 and Aug 18, 2026 — classified as 4 injuries.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 18, 2026Adverse Event Without Identified Device or Use Problem

  During an initial implant procedure, after implanting the leads, the catheter was used for a coronary sinus cannulation. Contrast was then injected and it was observed that there was a dissection of the coronary sinus. The physician decided to not implant the left ventricular (LV) lead. The patient is stable with no consequences.

  Patient problems: Vascular Dissection

  MAUDE report 50304253 ↗
• InjuryDec 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2023-94634. RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2023-94635. RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2023-94636. IT WAS REPORTED DURING A SYSTEM IMPLANT PROCEDURE, THE PATIENT EXPERIENCED A CARDIAC PERFORATION RESULTING IN PERICARDIAL EFFUSION. THE ENTIRE SYSTEM WAS REMOVED TO RESOLVE THE ISSUE. NO FURTHER ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 18315542 ↗
• InjuryDec 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN IMPLANT PROCEDURE, WHILE CANNULATING THE CORONARY SINUS USING THE CPS CATHETER A PERICARDIAL EFFUSION WAS NOTED. THE PROCEDURE WAS SUCCESSFULLY FINISHED AND THE EFFUSION DID NOT LEAD TO A TAMPONADE. NO INTERVENTION WAS REQUIRED. ADDITIONALLY, DIAGNOSTIC IMAGING WAS PERFORMED FOLLOWING THE PROCEDURE AND NO RELEVANT PERICARDIAL EFFUSION WAS NOTED. THE PATIENT WAS STABLE.

  Patient problems: Pericardial Effusion

  MAUDE report 16004514 ↗
• InjuryNov 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN IMPLANT PROCEDURE, A PERICARDIAL EFFUSION WAS OBSERVED VIA DIAGNOSTIC IMAGING. THE PHYSICIAN ALLEGED A PERFORATION WAS THE CAUSE OF THE EFFUSION, HOWEVER, IT REMAINS UNKNOWN ON WHETHER OR NOT THE CATHETER WAS RELATED TO THE EVENT. NO ALLEGATION OF MALFUNCTION WAS MADE AGAINST THE CATHETER. PERICARDIOCENTESIS WAS PERFORMED TO RESOLVE THE EFFUSION AND THE PROCEDURE WAS COMPLETED AS EXPECTED. THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE PROCEDURE

  Patient problems: Cardiac Perforation

  MAUDE report 12746351 ↗