CPS Direct™ DS2C020Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 05415067004192), received between Jun 21, 2018 and Sep 21, 2026 — classified as 2 deaths, 18 injuries, 1 malfunction.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem

  During an implant procedure, a cardiac perforation occurred and was confirmed via contrast in the pericardial space. Additionally, diagnostic imaging was performed and confirmed a pericardial effusion. The implant procedure was abandoned, but the patient was in stable condition leaving the operating room.

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 50838718 ↗
• InjuryFeb 4, 2026Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR AN IMPLANT PROCEDURE. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THE LEAD, IT WAS NOTED THAT MANEUVERABILITY WAS POOR. ADDITIONALLY, UPON IMAGING, IT WAS NOTED THAT PATIENT HAD THROMBUS. THE CATHETER WAS REMOVED AND NO ADDITIONAL INTERVENTION WAS PERFORMED. THE PATIENT EXPERIENCED NO CONSEQUENCES.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24259299 ↗
• InjuryJul 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR AN IMPLANT PROCEDURE. DURING THE PROCEDURE, THE PATIENT EXPERIENCED A PERFORATION, WHICH WAS CONFIRMED UNDER X-RAY. IT WAS UNKNOWN IF ADDITIONAL INTERVENTION WAS PERFORMED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Cardiac Perforation

  MAUDE report 22642014 ↗
• InjurySep 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN IMPLANT PROCEDURE, THE CATHETER WAS BEING WITHDRAWN FROM THE CORONARY SINUS WHEN A DISSECTION OF THE HEART WAS OBSERVED. X-RAY IMAGING AND AN ECHOCARDIOGRAM WERE PERFORMED, BUT THE EXACT LOCATION OF THE DISSECTION WAS UNABLE TO BE DETERMINED. ADDITIONALLY, THROUGH THE ECHOCARDIOGRAM, A PERICARDIAL EFFUSION WAS OBSERVED. THE PROCEDURE WAS STOPPED AND NO FURTHER INTERVENTION WAS PERFORMED. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED.

  Patient problems: Pericardial Effusion; Vascular Dissection

  MAUDE report 17799658 ↗
• MalfunctionJul 26, 2022Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE CATHETER WAS EXTREMELY TIGHT, AND THE PHYSICIAN WAS NOT ABLE TO ADVANCE THE LEAD. BOTH CATHETERS WERE DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15107942 ↗
• InjuryMar 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING ATTEMPTED IMPLANT OF A LEFT VENTRICULAR (LV) LEAD, VEIN DISSECTION OCCURRED FOLLOWING USE OF THE BALLOON CATHETER WITH THE STEERABLE CATHETER, LEADING TO CARDIAC TAMPONADE. ADDITIONAL SURGERY WAS REQUIRED AND THE PATIENT WAS HOSPITALIZED. THE PATIENT WAS IN STABLE CONDITION AND WILL CONTINUE TO BE MONITORED.

  Patient problems: Cardiac Perforation

  MAUDE report 13660063 ↗
• InjuryFeb 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PROCEDURE, A CORONARY SINUS DISSECTION WAS IDENTIFIED WITH A CONTRAST AGENT. THE PHYSICIAN ELECTED TO TERMINATE THE PROCEDURE TO RESOLVE THE EVENT. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Vascular Dissection

  MAUDE report 13548960 ↗
• InjuryNov 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING INITIAL IMPLANT, WHILE SEARCHING FOR A VEIN, THE PHYSICIAN NOTED A CARDIAC PERFORATION. AN ECHOCARDIOGRAPHY WAS PERFORMED, HOWEVER, NO EFFUSION WAS OBSERVED. THE LEAD WAS IMPLANTED IN A NEW LOCATION TO RESOLVE THE EVENT. THE PATIENT WAS STABLE

  Patient problems: Cardiac Perforation

  MAUDE report 12745993 ↗
• InjuryNov 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT PRESENTED FOR A DEVICE IMPLANT PROCEDURE ON (B)(6) 2021. DURING THE PROCEDURE, THE PATIENT'S CORONARY SINUS WAS DISSECTED BY AN OUTER CATHETER. THE PATIENT WAS STABLE THROUGHOUT.

  Patient problems: Vascular Dissection

  MAUDE report 12737056 ↗
• InjuryOct 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A PROCEDURE. DURING THE PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO CANNULATE THE CORONARY THE OSTIUM WAS DISSECTED. THE PATIENT DEVELOPED A PERICARDIAL EFFUSION WITHOUT CONSEQUENCES. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Pericardial Effusion; Vascular Dissection

  MAUDE report 12714269 ↗
• InjuryFeb 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A DISSECTION OF THE CORONARY SINUS DURING IMPLANT OF THE LEFT VENTRICULAR (LV) LEAD. THE LV LEAD WAS NOT IMPLANTED. NO INTERVENTION WAS PERFORMED; THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE AND THERE WERE NO ADVERSE CONSEQUENCES.

  Patient problems: Vascular Dissection

  MAUDE report 11369284 ↗
• InjuryOct 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR AN IMPLANT PROCEDURE. DURING THE PROCEDURE, THE CATHETER DISSECTED THE CORONARY SINUS THAT LED TO A MILD PERICARDIAL EFFUSION. THE PHYSICIAN ELECTED TO ABANDON THE IMPLANT OF THE LEFT VENTRICULAR LEAD AND PLUG THE CORRESPONDING PORT ON THE DEVICE. THE PATIENT WAS MONITORED AND IN STABLE CONDITION.

  Patient problems: Pericardial Effusion; Vascular Dissection

  MAUDE report 10764546 ↗
• InjurySep 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN UPGRADE PROCEDURE, THE PATIENT'S CORONARY SINUS WAS DISSECTED WHILE TRYING TO CANNULATE WITH THE CATHETER. THE PROCEDURE WAS STOPPED AND AN ECHO WAS PERFORMED, WHICH DID NOT SHOW A PERICARDIAL EFFUSION. THE PATIENT WAS DISCHARGED THE NEXT DAY IN STABLE CONDITION. THERE WERE NO ADVERSE PATIENT SYMPTOMS REPORTED.

  Patient problems: Vascular Dissection

  MAUDE report 10601356 ↗
• InjuryJun 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN IMPLANT PROCEDURE, THE CATHETER USED TO GUIDE THE LEFT VENTRICULAR (LV) LEAD DISSECTED THE CORONARY SINUS. THE LV LEAD IMPLANTATION WAS ABANDONED AND NO FURTHER INTERVENTION WAS PERFORMED TO RESOLVE THE DISSECTION. THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 10171125 ↗
• InjuryFeb 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING IMPLANT, THE SHEATH OF THE OUTER CATHETER DISSECTED THE CORONARY SINUS DURING CANNULATION. THE SHEATH WAS WITHDRAWN AND PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) WIRE WAS USED TO REACH THE TARGET VEIN AND IMPLANT THE LEAD. NO ADDITIONAL INTERVENTION WAS PERFORMED AND THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Vascular Dissection

  MAUDE report 9676033 ↗
• InjuryDec 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING IMPLANT OF THE LEFT VENTRICULAR (LV) LEAD, THERE WAS DIFFICULTY INSERTING THE DELIVERY CATHETHER INTO THE CORONARY SINUS. IT WAS NOTED THAT THE CATHETER HAD CAUSED A DISSECTION LEADING TO A PERICARDIAL EFFUSION. THE LV LEAD WAS NOT IMPLANTED; THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE AND WILL CONTINUE TO BE MONITORED.

  Patient problems: Pericardial Effusion; Vascular Dissection

  MAUDE report 9531741 ↗
• DeathOct 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER:2017865-2019-14938, 2017865-2019-14940, 2017865-2019-14942, 2017865-2019-14944, 2017865-2019-14945. IT WAS REPORTED THAT THE PATIENT EXPIRED DURING AN IMPLANT PROCEDURE. THERE IS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT SUGGESTS THE DEATH WAS RELATED TO THE DEVICE. IT WAS REPORTED THAT THE CAUSE OF DEATH WAS DUE TO RESPIRATORY ISSUES DURING THE PROCEDURE.

  Patient problems: Death

  MAUDE report 9177013 ↗
• DeathOct 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER:2017865-2019-14938, 2017865-2019-14940, 2017865-2019-14942, 2017865-2019-14943, 2017865-2019-14944, 2017865-2019-14945. IT WAS REPORTED THAT THE PATIENT EXPIRED DURING AN IMPLANT PROCEDURE. THERE IS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT SUGGESTS THE DEATH WAS RELATED TO THE DEVICE. IT WAS REPORTED THAT THE CAUSE OF DEATH WAS DUE TO RESPIRATORY ISSUES DURING THE PROCEDURE.

  Patient problems: Death

  MAUDE report 9177004 ↗
• InjuryApr 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING IMPLANT, DISSECTION OF THE CORONARY SINUS OCCURRED AFTER USE OF THE CATHETER. THE PROCEDURE WAS CANCELLED. THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 8527557 ↗
• InjuryNov 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR AN IMPLANT PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE PATIENT HAD A PERICARDIAL EFFUSION. PERICARDIOCENTESIS AND CARDIOPULMONARY RESUSCITATION WAS PERFORMED. THE PATIENT WAS ALSO GIVEN ADRENALINE. IT IS UNKNOWN WHAT CAUSED THE PERICARDIAL EFFUSION. ALL PRODUCTS WERE EXPLANTED AND THE WOUND WAS CLOSED. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Perforation; Pericardial Effusion

  MAUDE report 8094770 ↗
• InjuryJun 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A SYSTEM UPGRADE PROCEDURE, THE CATHETER TO THE LEFT VENTRICULAR LEAD PERFORATED THE MYOCARDIAL TISSUE. THE PATIENT¿S BLOOD PRESSURE DROPPED GRADUALLY AND CONTINUED FOR ABOUT TWENTY MINUTES. THE PHYSICIAN PERFORMED A PERICARDIOCENTESIS. THE PATIENT¿S BLOOD PRESSURE STABILIZED. THE LEFT VENTRICULAR LEAD WAS NOT IMPLANTED AND THE PORT WAS PLUGGED. THE PATIENT¿S CONDITION POST PROCEDURE WAS STABLE.

  Patient problems: Perforation; Pericardial Effusion

  MAUDE report 7627679 ↗