Evolution G23737Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10827002237374), received between Jun 30, 2021 and Jan 23, 2026 — classified as 2 deaths, 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THE FOLLOWING INFORMATION TO COOK JAPAN. UPON ATTEMPTING TO REMOVE THE RIGHT ATRIAL (RA) LEAD, THE EVOLUTION CAUSED AN INJURY TO THE SUPERIOR VENA CAVA (SVC). A BRIDGE BALLOON [NON-COOK PRODUCT] WAS DEPLOYED TO CONTROL THE BLEEDING, FOLLOWED BY AN OPEN-CHEST PROCEDURE. THE PATIENT WAS THEN RETURNED TO THE INTENSIVE CARE UNIT. DUE TO THE SVC INJURY, THE LEAD REMOVAL WAS DISCONTINUED, AND THE RA EXTRACTION PROCEDURE WAS NOT COMPLETED.

  Patient problems: Great Vessel Perforation

  MAUDE report 24163373 ↗
• InjurySep 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE LR-EVN-9.0-RL WAS REMOVED BY MANIPULATING IT LITTLE BY LITTLE IN THE CORONARY SINUS (CS). AFTER REMOVAL, PERICARDIAL FLUID GRADUALLY ACCUMULATED, AND BLOOD PRESSURE DROPPED FROM 80 TO 50. HOWEVER, IT QUICKLY RECOVERED WITH FLUID INFUSION AND VASOPRESSORS. CARDIAC TAMPONADE WAS SUSPECTED, SO DRAINAGE WAS CONSIDERED. AS THERE WAS NOT ENOUGH FLUID TO ALLOW PUNCTURE, A REQUEST WAS MADE TO THE SURGEON, WHO OPENED THE EPIGASTRIUM AND PERFORMED DRAINAGE. IT WAS THOUGHT THAT A PARTIAL THROMBUS HAD ALREADY FORMED AND THE BLEEDING HAD STOPPED NATURALLY. THERE IS LIKELY DAMAGE SOMEWHERE IN THE CS, BUT THE INJURY WAS CAUSED BY THE PRODUCT OR BY REMOVING THE LEAD, AND THE CAUSE OF THE COMPLICATION IS NOT CLEAR. THERE WAS NO EXTENSION OF HOSPITAL STAY OR DISABILITY.

  Patient problems: Cardiac Tamponade; Low Blood Pressure/ Hypotension

  MAUDE report 23009470 ↗
• InjurySep 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICES INVOLVED FOR LEAD EXTRACTION: LR-NES001 (LOT N199524)---APPROACHED FROM THE RIGHT FEMORAL ARTERY FOR A RV LEAD. LR-EVN-SH-9.0-RL (LOT N202627)---APPROACHED FROM THE LEFT SUBCLAVIAN VEIN FOR A RV LEAD. LR-EVN-9.0-RL (LOT N202107)---APPROACHED FROM THE LEFT SUBCLAVIAN VEIN FOR A RV LEAD. TRANSVENOUS LEAD EXTRACTION (TLE) WAS COMPLETED SUCCESSFULLY. SUBSEQUENTLY, WHEN A NEW LEAD WAS IMPLANTED, THE GUIDE WIRE WOULD NOT PASS, SO A GUIDING CATHETER AND A GUIDE WIRE WITH A HEAVY TIP LOAD WERE USED, AMONG OTHER DEVICES (PRODUCT NAME/LOT#: UNKNOWN). WHEN THE IMPLANTATION OF THE PACEMAKER LEAD WAS COMPLETED, THE PATIENT'S BLOOD PRESSURE GRADUALLY DECREASED, RESULTING IN CARDIAC TAMPONADE. PERICARDIAL DRAINAGE WAS PERFORMED AND 100 CC OF PERICARDIAL FLUID WAS REMOVED.

  Patient problems: Cardiac Tamponade; Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 20245355 ↗
• InjuryJul 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  APPROACH VIA THE LEFT SUBCLAVIAN VEIN. BELOW ARE THE DEVICES USED, AND ALL DEVICES WERE NOT DEFECTIVE. -LR-EVN-9.0-RL/N197250. -LR-OFA01/N194396. -500-301/GLIDELIGHT12FR. -LR-EVN-11.0-RL (UNKNOWN LOT). DURING REMOVAL OF THE RA LEAD, 500-301/GLIDELIGHT12FR AND THEN THE LR-EVN-9.0-RL WAS USED TO DETACH THE LEAD TO THE RING ELECTRODE, AFTER CHANGING TO LR-EVN-11.0-RL AND ADVANCING THE SHEATH ALONG THE LEAD, THE RA LEAD CAME LOOSE JUST BEFORE IT REACHED THE RING ELECTRODE. SUBSEQUENTLY, WHILE CHECKING THE PATIENT WITH TRANSESOPHAGEAL ECHOCARDIOGRAPHY, HIS BLOOD PRESSURE DROPPED, SO A CARDIOVASCULAR SURGEON PERFORMED A MEDIAN STERNOTOMY AND PERFORMED A REPAIR PROCEDURE ON THE RIGHT ATRIAL APPENDAGE. AFTER THE PROCESS, DR. (B)(6) COMMENTED THAT THE LEAD THAT CAME OUT BROUGHT TISSUE FROM THE RIGHT ATRIAL APPENDAGE WITH IT, WHICH PROBABLY CAUSED CARDIAC TAMPONADE. HE DID NOT THINK IT WAS A COMPLICATION CAUSED BY EVOLUTION.

  Patient problems: Cardiac Tamponade; Low Blood Pressure/ Hypotension

  MAUDE report 19666915 ↗
• DeathJun 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE LITERATURE REPORT SPECIFIES TWO DEATHS IN A RETROSPECTIVE STUDY IN PATIENTS RECOMMENDED FOR CIED (CARDIOVASCULAR IMPLANTABLE ELECTRONIC DEVICE) REMOVAL FROM JANUARY 2012 TO JUNE 2018. ALL PROCEDURES WERE PERFORMED BY THE SAME CARDIAC SURGEON. SIMPLE RETRACTION WAS ATTEMPTED FIRST AND, IF NOT SUCCESSFUL, THE EVOLUTION OR THE EVOLUTION RL MECHANICAL SHEATHS BY COOK MEDICAL WERE USED. TWO PATIENTS DIED DUE TO RIGHT ATRIUM AND SUPERIOR VENA CAVA TEARS DURING THE PROCEDURE.

  Patient problems: Cardiac Perforation

  MAUDE report 12092786 ↗
• DeathJun 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER COMPLAINT FORM - ALL PATIENTS WITH THE RECOMMENDATION OF CIED (CARDIOVASCULAR IMPLANTABLE ELECTRONIC DEVICE) REMOVAL FROM (B)(6) 2012 TO (B)(6) 2018 WERE INCLUDED. ALL PROCEDURES WERE PERFORMED BY THE SAME CARDIAC SURGEON. SIMPLE RETRACTION WAS ATTEMPTED FIRST AND, IF NOT SUCCESSFUL, THE EVOLUTION OR THE EVOLUTION RL MECHANICAL SHEATHS BY COOK MEDICAL WERE USED. TWO PATIENTS DIED DUE TO RIGHT ATRIUM AND SUPERIOR VENA CAVA TEARS DURING PROCEDURE.

  Patient problems: Great Vessel Perforation

  MAUDE report 12092780 ↗