CPS DIRECT™ 410212Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 05414734207072), received between Aug 22, 2018 and Jul 10, 2023 — classified as 10 injuries.

The most frequently reported specific device problem is “Difficult to Advance” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJul 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, WHILE POSITIONING THE CATHETER TO THE LEFT VENTRICLE, DISSECTION OF THE CORONARY SINUS WAS OBSERVED. A LEFT VENTRICULAR LEAD WAS NOT IMPLANTED AND NO ADDITIONAL INTERVENTION HAS BEEN PERFORMED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Vascular Dissection

  MAUDE report 17287685 ↗
• InjuryJun 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2023-22377 / 2017865-2023-22378 / 2017865-2023-22379. IT WAS REPORTED THAT THE PATIENT PRESENTED FOR AN IMPLANT PROCEDURE. DURING THE PROCEDURE, THE PATIENT EXPERIENCED ACUTE HEART FAILURE. IT WAS UNKNOWN IF THE LEADS AND CATHETER CONTRIBUTED TO THE HEART FAILURE. THE LEADS WERE NOT IMPLANTED, AND THE PROCEDURE WAS ABORTED. THE PATIENT CONDITION WAS STABLE.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 17059426 ↗
• InjuryAug 10, 2022Difficult to Advance; Material Twisted/Bent; Difficult to Advance; Material Twisted/Bent

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2022-17306. IT WAS REPORTED THAT THE PATIENT PRESENTED TO A SCHEDULED PROCEDURE. DURING THE IMPLANT PROCEDURE, THE CATHETER COULD NOT BE ADVANCED SMOOTHLY THROUGH THE LEFT VENTRICULAR LEAD. THE PHYSICIAN SUSPECTED THAT THE CATHETER WAS BENT. WHILE ATTEMPTING TO IMPLANT THE LEFT VENTRICULAR LEAD, THE LEAD EXHIBITED HIGH THRESHOLD AND FAILURE TO CAPTURE. THE LEFT VENTRICULAR LEAD IMPLANT WAS ABANDONED AS THE PATIENT DEVELOPED CORONARY SINUS DISSECTION DURING THE PROCEDURE. THE PATIENT CONDITION WAS STABLE POST-PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 15201092 ↗
• InjuryOct 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE IMPLANT PROCEDURE OF THE LEFT VENTRICULAR (LV) LEAD, THERE WERE A DISSECTION OF THE CORONARY SINUS NOTED. THE CORONARY SINUS WAS CANNULATED WITH CPS DIRECT PL, AND AN INITIAL CONTRAST INJECTION DID NOT SHOW SIGNS OF DISSECTION. DURING POSITIONING OF THE LEAD WITH THE CPS COURIER GUIDEWIRE, A NEW VENOGRAPHY WAS PERFORMED, WHICH SHOWED A SMALL DISSECTION OF THE CORONARY SINUS. IN THE PHYSICIAN¿S OPINION, THE DISSECTION WAS CAUSED BY EITHER THE CPS DIRECT PL, OR THE CPS COURIER GUIDEWIRE. THE PROCEDURE WAS ABANDONED, AND THE LV LEAD WAS NOT IMPLANTED. A NEW LV LEAD WAS IMPLANTED AT A LATER DATE, AND THE DISSECTION HAD HEALED. THE PATIENT WAS STABLE WITH NO CONSEQUENCES. RELATED MANUFACTURER REPORT NUMBER: 2017865-2020-15827.

  Patient problems: Vascular Dissection

  MAUDE report 10741337 ↗
• InjuryFeb 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE IMPLANT PROCEDURE, DIAGNOSTIC IMAGING REVEALED THE GUIDEWIRE WAS IN THE PERICARDIUM INSTEAD OF THE RIGHT ATRIA. IT WAS SUGGESTED THE CPS INTRODUCER PERFORATED THE ANTERIOR VENA CAVA ALLOWING THE GUIDEWIRE TO MOVE INTO THE PERICARDIUM. THE PROCEDURE WAS DISCONTINUED, AND THE PATIENT WAS BROUGHT OFF THE CATECHOLAMINES ADMINISTERED DURING DEEP ANESTHESIA. THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE.

  Patient problems: Cardiac Perforation

  MAUDE report 9714675 ↗
• InjurySep 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A GENERATOR UPGRADE PROCEDURE. DURING THE PROCEDURE, THE SHEATH DISSECTED THE PATIENT'S OSTIUM. THE PHYSICIAN NOTED THAT THE PATIENT HAD ABNORMAL ANATOMY. THE PROCEDURE WAS ABANDONED. THE SHEATH WAS DISCARDED. A POST-PROCEDURE ECHO REVEALED EFFUSION. NO FURTHER TREATMENT WAS NEEDED AT THE TIME AND THE PATIENT WAS STABLE AND WILL FOLLOW UP ONCE HEALED.

  Patient problems: Pericardial Effusion; Vascular Dissection

  MAUDE report 9088091 ↗
• InjuryJul 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING IMPLANT, THE PHYSICIAN INSERTED THE CPS DIRECT INTRODUCER INTO THE CORONARY SINUS. IMAGING REVEALED A DISSECTION, FOR WHICH NO INTERVENTION WAS REQUIRED. THE PHYSICIAN SUCCESSFULLY FINISHED THE IMPLANT PROCEDURE. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Vascular Dissection

  MAUDE report 8823701 ↗
• InjuryJun 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN IMPLANT PROCEDURE OF A LEFT VENTRICULAR (LV) LEAD, DURING CANNULATION OF THE CATHETER AND INJECTION OF DYE, DISSECTION OF THE CORONARY SINUS WAS NOTED. THE PHYSICIAN ELECTED TO ABANDON THE PROCEDURE AND CAP THE DEVICE PORT. NO FURTHER MEDICAL INTERVENTION WAS PERFORMED. THE PATIENT WAS STABLE.

  Patient problems: Vascular Dissection

  MAUDE report 8707614 ↗
• InjuryOct 23, 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 PROCEDURE, ATRIAL AND VENTRICULAR LEADS WERE SUCCESSFULLY IMPLANTED. WHILE IMPLANTING THE PACEMAKER THE CORONAL SINUS WAS UNABLE TO BE FOUND AND THE PATIENT DEVELOPED SEVERE HEART FAILURE WHICH OBSTRUCTED THE SURGICAL PROCEDURE. THE PATIENT WAS THEN SENT TO CARDIAC CARE UNIT (CCU) FOR TREATMENT. THERE IS NO ALLEGATION OF MALFUNCTION FROM THE HEALTH CARE PROFESSIONAL THAT ITS RELATED TO DEVICE, SHEATH OR LEADS. THE PATIENT WAS IMPLANTED SELECTIVELY AND DISCHARGED.

  Patient problems: Heart Failure

  MAUDE report 7993970 ↗
• InjuryAug 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE OPERATION ROOM FOR AN INITIAL IMPLANT. DURING THE PROCEDURE A MULTI-FUNCTIONAL CATHETER WAS USED TO FIND THE CORONARY SINUS VEIN. THE VEIN WAS TOO SMALL, THE PHYSICIAN THEN USED SOME FORCE TO INSERT THE CATHETER AND THAT CAUSED CARDIAC PERFORATION. THE PATIENT WAS UNSTABLE AND THE LEAD WAS NOT USED. THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: Perforation

  MAUDE report 7807404 ↗