CPS DIRECTRecalls & reported problems across all models

We found 16 models of CPS DIRECT by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 81 adverse event reports in the FDA's MAUDE database, received between Jun 18, 2018 and Sep 21, 2026 — classified as 6 deaths, 73 injuries, 2 malfunctions.

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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported CPS DIRECT problems

CPS DIRECT models

16 models, most reported first. Each model has its own page with its reports, recalls and device details.

• CPS Direct™ DS2C020

  CATHETER, PERCUTANEOUS
  2 deaths21 reports
• CPS Direct™ DS2C019

  CATHETER, PERCUTANEOUS
  2 deaths15 reports
• CPS DIRECT™ 410212

  Catheter, percutaneous
  10 reports
• CPS Direct™ DS2C021

  CATHETER, PERCUTANEOUS
  1 death9 reports
• CPS DIRECT™ 410213

  Catheter, percutaneous
  4 reports
• CPS Direct™ DS2C018

  CATHETER, PERCUTANEOUS
  4 reports
• CPS DIRECT™ 410211

  Catheter, percutaneous
  3 reports
• CPS Direct™ DS2C022

  CATHETER, PERCUTANEOUS
  3 reports
• CPS Direct™ DS2C029

  CATHETER, PERCUTANEOUS
  3 reports
• CPS DIRECT™ DS2C003

  CATHETER, PERCUTANEOUS
  2 reports
• CPS Direct™ DS2C023

  CATHETER, PERCUTANEOUS
  1 death2 reports
• CPS DIRECT™ PL

  CATHETER, PERCUTANEOUS
  1 report
• CPS DIRECT™ 410210

  Catheter, percutaneous
  1 report
• CPS DIRECT™ DS2C002

  CATHETER, PERCUTANEOUS
  1 report
• CPS DIRECT™ DS2C004

  CATHETER, PERCUTANEOUS
  1 report
• CPS DIRECT™ DS2C005

  CATHETER, PERCUTANEOUS
  1 report

Recent CPS DIRECT adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• 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 ↗
• DeathJan 12, 2026Material Too Rigid or Stiff

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR AN IMPLANT PROCEDURE. IT WAS REPORTED THAT, DURING INITIAL IMPLANT, THE CATHETER WAS RIGID AND CAUSED THE PATIENT'S HEART TO BE PERFORATED AND BLOCKED. THE PATIENT DECEASED.

  Patient problems: Arrhythmia; Cardiac Perforation; Vascular Dissection

  MAUDE report 24044338 ↗
• 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 ↗
• 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 ↗
• InjuryNov 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INITIAL IMPLANT PROCEDURE, THE PATIENT DEVELOPED A PERFORATION OF THE EPICARDIUM WHILE MANEUVERING THE CATHETER. LATER DURING THE PROCEDURE, THE PERFORATION RESULTED IN A PERICARDIAL EFFUSION WHICH RESULTED IN THE PATIENT LOSING CONSCIOUSNESS AND CEASING BREATHING. CARDIOPULMONARY RESUSCITATION WAS ADMINISTERED UNTIL THE PATIENT STABILIZED. THE IMPLANT PROCEDURE WAS ABANDONED. NO ALLEGATION OF MALFUNCTION WAS MADE AGAINST THE CATHETER. LEAD IMPLANTATION IS STILL BEING CONSIDERED. HOWEVER, NO FURTHER INTERVENTION WAS PERFORMED AT THIS TIME. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Cardiac Perforation; Pericardial Effusion; Syncope/Fainting

  MAUDE report 20775986 ↗
• 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 ↗
• InjurySep 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING IMPLANT, IT WAS REPORTED THAT THE PATIENT EXPERIENCED CHEST PAIN AND BRADYCARDIA FOLLOWING A VASCULAR DISSECTION DUE TO USE OF THE CATHETER. A PERICARDIAL EFFUSION WAS OBSERVED. A PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT WILL CONTINUE TO BE MONITORED.

  Patient problems: Arrhythmia; Cardiac Perforation; Pericardial Effusion; Vascular Dissection

  MAUDE report 20158180 ↗
• InjuryAug 13, 2024Adverse 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, WHILE INSERTING THE CATHETER, THE CORONARY SINUS WAS DISSECTED. UPON X-RAY EXAMINATION, THE DISSECTION WAS CONFIRMED TO HAVE CAUSED A PERFORATION. THE PHYSICIAN ATTEMPTED TO IMPLANT THE LEFT VENTRICULAR LEAD AND WAS UNSUCCESSFUL. NO ADDITIONAL INTERVENTION WAS PERFORMED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Cardiac Perforation; Vascular Dissection

  MAUDE report 19972731 ↗
• InjuryJun 12, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED DURING IMPLANT PROCEDURE. DURING THE IMPLANT OF THE LEFT VENTRICULAR LEAD, THE OUTER SHEATH POPPED OUT OF THE CORONARY SINUS AND VASCULAR DISSECTION WAS NOTED WHILE THE CATHETER ATTEMPTED TO ENTER THE CORONARY SINUS AGAIN. THE IMPLANT OF LEFT VENTRICULAR LEAD WAS ABANDONED AND THE PHYSICIAN ELECTED TO IMPLANT A SINGLE CAVITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR ON (B)(6) 2024. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Vascular Dissection

  MAUDE report 19520037 ↗
• 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 ↗
• InjuryDec 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR IMPLANT PROCEDURE. DURING THE PROCEDURE, WHEN INSERTING THE CATHETER, IT WAS NOTED THAT THE PATIENT EXPERIENCED A DISSECTION. NO INTERVENTION WAS PERFORMED TO RESOLVE THE DISSECTION. THE IMPLANT PROCEDURE WAS COMPLETED AND THE PATIENT WAS IN STABLE CONDITION THROUGHOUT.

  Patient problems: Vascular Dissection

  MAUDE report 18337581 ↗
• 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 ↗

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