CPS Direct™ DS2C018Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05415067004178), received between Jan 30, 2019 and Mar 21, 2024 — 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.

• InjuryMar 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING ATTEMPTED IMPLANT OF THE LEFT VENTRICULAR (LV) LEAD, A PERICARDIAL EFFUSION WAS OBSERVED FOLLOWING USE OF THE CATHETER. DIAGNOSTIC IMAGING WAS PERFORMED AND CARDIAC PERFORATION WAS CONFIRMED. A PERICARDIOCENTESIS WAS PERFORMED TO TREAT THE CARDIAC PERFORATION. THE PATIENT WAS IN STABLE CONDITION AND NO FURTHER ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: Cardiac Perforation

  MAUDE report 18955782 ↗
• InjuryApr 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REPORT NUMBER: 2017865-2022-07634, RELATED MANUFACTURER REPORT NUMBER: 2017865-2022-07636, RELATED MANUFACTURER REPORT NUMBER: 2017865-2022-07637. IT WAS REPORTED THAT DURING LEFT VENTRICULAR (LV) LEAD IMPLANT PROCEDURE THE PATIENT EXPERIENCED A PERFORATION RESULTING IN TAMPONADE. THE PHYSICIAN PERFORMED PERICARDIAL DRAIN TO RESOLVE THE ISSUE. THE PATIENT CONDITION WAS STABLE.

  Patient problems: Cardiac Perforation; Cardiac Tamponade

  MAUDE report 14079278 ↗
• InjuryJun 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 AFTER THE CANNULATION OF THE CORONARY SINUS WITH THE CATHETER AT THE OSTIUM. THE EFFUSION DID NOT EFFECT THE CONDITION OF THE PATIENT AND THE IMPLANT PROCEDURE WAS SUCCESSFULLY COMPLETED. FOLLOWING THE PROCEDURE AN ULTRASOUND IMAGING WAS PERFORMED AND THE EFFUSION WAS STABLE. NO FURTHER INTERVENTION IS ANTICIPATED. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED.

  Patient problems: Pericardial Effusion

  MAUDE report 11936636 ↗
• InjuryJan 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN IMPLANT PROCEDURE, WHILE PLACING A STRAIGHT CATHETER IN THE CORONARY SINUS (CS), X-RAY WAS PERFORMED AND REVEALED A DISSECTION OF THE CS. A SECOND ATTEMPT TO PLACE THE STRAIGHT CATHETER INTO THE CS WAS USED WITH A BALLOON CATHETER, HOWEVER, THE STRAIGHT CATHETER COULD NOT BE POSITIONED CORRECTLY IN THE CS. THE PROCEDURE WAS TERMINATED AND THE PATIENT REMAINED IN THE HOSPITAL. FOLLOWING THE PROCEDURE, AN ECHOCARDIOGRAM WAS PERFORMED AND REVEALED NO PERICARDIAL EFFUSION. THE PATIENT WAS STABLE AND ASYMPTOMATIC. NO ADDITIONAL INTERVENTION WAS PERFORMED. THERE WAS NO ALLEGED MALFUNCTION AGAINST THE PERFORMANCE OF ANY ABBOTT DEVICE.

  Patient problems: Vascular Dissection

  MAUDE report 8289429 ↗