CPS Direct™ DS2C019Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 05415067004185), received between Oct 5, 2018 and Jan 12, 2026 — classified as 2 deaths, 13 injuries.

The most frequently reported specific device problem is “Material Too Rigid or Stiff” (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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• InjuryMay 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CORONARY SINUS DISSECTION AND EFFUSION WERE OBSERVED WHILE ADVANCING THE POSITIONING CATHETER DURING THE IMPLANT PROCEDURE. THE PHYSICIAN ALLEGE THE EVENT WAS RELATED TO THE TORTUOUS ANATOMY OF THE PATIENT AND NOT DUE TO THE PERFORMANCE OF THE CATHETER. AS A RESULT, THE IMPLANT PROCEDURE WAS ABANDONED AND WILL BE PERFORMED AT A LATER DATE. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Pericardial Effusion; Vascular Dissection

  MAUDE report 16974958 ↗
• DeathMar 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INITIAL IMPLANT PROCEDURE WHILE THE PHYSICIAN WAS MANEUVERING THE CATHETER INTO THE CORONARY SINUS, THE CATHETER CAUSED A SMALL CORONARY DISSECTION. THE CORONARY DISSECTION RESULTED IN A SMALL NON-HEMODYNAMICALLY RELEVANT PERICARDIAL EFFUSION. THE PATIENT REMAINED STABLE, AND NO INTERVENTION WAS REQUIRED TO ADDRESS THE EFFUSION. THE IMPLANT PROCEDURE WAS THEN COMPLETED WITHOUT ANY FURTHER COMPLICATIONS. AFTER THE PROCEDURE WAS COMPLETED AND WHILE THE PATIENT WAS BEING MOVED FROM THE OPERATING TABLE, THE PATIENT EXPERIENCED A PULSELESS TACHYCARDIA. CARDIOPULMONARY RESUSCITATION WAS ADMINISTERED, HOWEVER, THE PATIENT LATER PASSED AWAY. ALTHOUGH THE DIRECT CAUSE OF DEATH REMAINS UNKNOWN AT THIS TIME, THE PHYSICIAN NOTED THAT THE REPORTED PERICARDIAL EFFUSION DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT'S DEATH. IN ADDITION, THE PHYSICIAN DID NOT ALLEGE ANY MALFUNCTION AGAINST THE ABBOTT DEVICE AND DID NOT BELIEVE ANY ABBOTT PRODUCTS OR THE PROCEDURE CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH IN ANY WAY.

  Patient problems: Pericardial Effusion; Vascular Dissection

  MAUDE report 16497031 ↗
• InjuryJun 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING ATTEMPTED IMPLANT, THERE WAS A DISSECTION OF THE CORONARY SINUS FOLLOWING THE USE OF THE CATHETER. INCREASED BLOOD PRESSURE AND TACHYCARDIA WAS OBSERVED. CHEST COMPRESSIONS WERE PERFORMED AND THE PATIENT'S WAS IN STABLE CONDITION.

  Patient problems: Arrhythmia; High Blood Pressure/ Hypertension; Vascular Dissection

  MAUDE report 14836300 ↗
• InjuryJun 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2022-11824. RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2022-11827. IT WAS REPORTED THAT A PATIENT PRESENTED IN-CLINIC FOR AN EXPLANT PROCEDURE. EXAMINATION OF THE PATIENT'S LEAD REVEALED HIGH CAPTURE THRESHOLDS. DURING THE PROCEDURE AND DURING AN ATTEMPT TO PLACE A LEFT VENTRICULAR LEAD WAS FOUND TO BE DIFFICULT TO REMOVE FROM THE GUIDEWIRE, AND THE LEFT VENTRICULAR LEAD WAS FOUND TO BE DAMAGED. ADDITIONALLY, A STEERABLE CATHETER USED WAS FOUND TO HAVE PERFORATED THE PATIENT BLOOD VESSELS, RESULTING IN ADDITIONAL SURGICAL INTERVENTION TO RESOLVE THE COMPLICATION. THE EXITING LEAD WAS CAPPED ON (B)(6) 2022, AND IMPLANT OF THE LEFT VENTRICULAR LEAD WAS ABANDONED. THE PATIENT WAS STABLE THROUGHOUT.

  Patient problems: Perforation of Vessels

  MAUDE report 14605058 ↗
• InjuryJun 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, PERICARDIAL EFFUSION WAS OBSERVED SUSPECTED TO BE DUE TO CARDIAC PERFORATION AS A RESULT OF INCORRECT INTUBATION OF THE CORONARY SINUS (CS) OSTIUM WITH THE CATHETER. FOLLOWING THE PROCEDURE, THE PERICARDIAL EFFUSION WAS TREATED WITH PERICARDIAL DRAINAGE AND AN ADDITIONAL SURGERY. NO ADDITIONAL INTERVENTION HAS BEEN PERFORMED AT THIS TIME. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 14569580 ↗
• InjuryApr 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, A SMALL DISSECTION OF THE CORONARY SINUS OCCURRED WHILE MANEUVERING THE CATHETER. THE LEFT VENTRICULAR LEAD WAS NOT IMPLANTED AND NO ADDITIONAL INTERVENTION WAS REQUIRED TO RESOLVE THE EVENT. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Vascular Dissection

  MAUDE report 14113233 ↗
• InjuryOct 25, 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 SYSTEM UPGRADE PROCEDURE. A CATHETER DELIVERY SYSTEM WAS USED TO CANNULATE THE OSTIUM OF THE CORONARY SINUS. WHEN CONTRAST WAS INJECTED INTO THE CORONARY SINUS, IT WAS REVEALED THAT THERE WAS A DISSECTION OF THE CORONARY SINUS. THE PHYSICIAN ELECTED NOT TO IMPLANT A LEAD INTO THE LEFT VENTRICULAR LOCATION. THE PATIENT WAS HEMODYNAMICALLY STABLE THROUGHOUT.

  Patient problems: Vascular Dissection

  MAUDE report 12694777 ↗
• InjuryJun 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING IMPLANT OF A LEFT VENTRICULAR (LV) LEAD, A DISSECTION OF THE CORONARY SINUS (CS) IN THE AREA BEHIND THE CS OSTIUM OCCURRED DURING CS INTUBATION. THE DISSECTION WAS NOT TREATED, FURTHER CS INTUBATION WAS STOPPED, AND THE LV LEAD WAS NOT IMPLANTED. FUTURE IMPLANT IS PLANNED AFTER THE DISSECTION HAS HEALED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Vascular Dissection

  MAUDE report 10106132 ↗
• InjuryFeb 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING A DEVICE UPGRADE PROCEDURE; AN INTRODUCER SHEATH WAS USED. AFTER ENTERING THE SHEATH, DYE WAS INJECTED AND A CORONARY SINUS DISSECTION WAS NOTED. THE PHYSICIAN REMOVED THE SHEATH AND ELECTED NOT TO PROCEED FURTHER. THE PATIENT WAS IMPLANTED A DUAL CHAMBER DEVICE. AN ECHOCARDIOGRAM WAS PERFORMED TO ENSURE THAT NO FURTHER ACTION WAS NEEDED. THE PATIENT WAS IN STABLE CONDITION POST-PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 9688561 ↗
• InjuryDec 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING IMPLANT, IT WAS REPORTED THAT THERE WAS DIFFICULTY INSERTING THE CATHETER INTO THE CORONARY SINUS DUE TO AIR BUBBLES. A DIFFERENT DELIVERY CATHETER WAS USED BUT IT WAS DISCOVERED THAT THE USE OF THE CATHETER HAD LED TO A DISSECTION OF THE CORONARY SINUS. THE LEFT VENTRICULAR (LV) LEAD WAS NOT IMPLANTED. THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 9453947 ↗
• InjuryNov 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING IMPLANT OF THE LEFT VENTRICULAR (LV) LEAD, A DISSECTION OF THE CORONARY SINUS WAS OBSERVED FOLLOWING USE OF THE DELIVERY CATHETER. THE LV LEAD WAS NOT IMPLANTED. THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE AND WILL CONTINUE TO BE MONITORED.

  Patient problems: Vascular Dissection

  MAUDE report 9379758 ↗
• InjuryFeb 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN IMPLANT PROCEDURE, THE MYOCARDIUM WAS PERFORATED BY AN IMPLANT CATHETER TOOL. THE PROCEDURE WAS CANCELED TO ALLOW RECOVERY AND REPEATED TWO MONTHS LATER TO IMPLANT THE DEVICE. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Perforation

  MAUDE report 8312467 ↗
• InjuryOct 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN IMPLANT PROCEDURE, WHILE USING THE CATHETER, DIAGNOSTIC IMAGING CONFIRMED A PERFORATION OF THE CORONARY SINUS. THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS DURING THE EVENT AND THE CASE WAS ABANDONED. THERE IS NO ALLEGED MALFUNCTION AGAINST ANY ABBOTT DEVICE. THE PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION.

  Patient problems: Cardiac Perforation

  MAUDE report 7940143 ↗