EvolutionRecalls & reported problems across all models

We found 8 models of Evolution by Cook Vandergrift Inc. in the FDA's device registry (GUDID). Together they are named in 50 adverse event reports in the FDA's MAUDE database, received between Jun 4, 2015 and Jul 31, 2026 — classified as 14 deaths, 36 injuries.

The most frequently reported specific device problem is “Break” (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 Evolution problems

Evolution models

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

• Evolution G23746

  DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
  5 deaths22 reports
• Evolution G23747

  DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
  5 deaths16 reports
• Evolution G23737

  DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
  2 deaths6 reports
• Evolution G23748

  DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
  1 death2 reports
• Evolution G23749

  DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
  1 report
• Evolution G49652

  DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
  1 report
• Evolution G46539

  DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
  1 report
• Evolution G46540

  DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
  1 death1 report

Recent Evolution adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryJul 31, 2026Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  The following information was received from Merit Medical on behalf of the user facility: Extraction procedure of an A-lead ((b)(6)) that had been in place for approximately 10 years. When the Evolution (EVO11) was advanced to the J-curve of the lead, the tip of the lead became detached. Subsequently, the patient developed hypotension, and an open thoracotomy was performed. A laceration was found around the Right Atrium Superior Vena Cava (RA-SVC) junction. After the thoracotomy, the chest was closed, and the patient was transferred out of the operating room.

  Patient problems: Laceration(s); Low Blood Pressure/ Hypotension

  MAUDE report 50098689 ↗
• 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 ↗
• InjuryDec 2, 2025Material Too Rigid or Stiff; Failure to Align; Adverse Event Without Identified Device or Use Problem; Material Too Rigid or Stiff; Failure to Align; Adverse Event Without Identified Device or Use Problem

  AS REPORTED ON THE MEDWATCH FORM: IN ACCORDANCE WITH TITLE 21 PART 803, SUBPART B, 803.22(B)(2), THIS LETTER IS TO NOTIFY AND PROVIDE YOU THE INFORMATION PHILIPS RECEIVED ON (B)(6) 2025 WHICH REPORTED THAT DURING A LEAD EXTRACTION PROCEDURE, A PERICARDIAI EFFUSION WAS OBSERVED, AND THORACOTOMY WAS PERFORMED TO REPAIR A CORONARY SINUS PERFORATION. THE PATIENT SURVIVED THE PROCEDURE. A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE RA, RV, AND LV LEADS DUE TO CIED SYSTEM/POCKET INFECTION. THE RA AND RV LEADS WERE PREPPED WITH LLDS AND THE LV LEAD WAS PREPPED WITH SUTURE AND STEEL WIRE TO PROVIDE TRACTION. THE RA AND RV LEADS WERE REMOVED SUCCESSFULLY. USING A SPECTRANETICS 12F GLIDELIGHT ADVANCEMENT COULD NOT BE MADE OVER THE CALCIFIED SUBCLAVIAN REGION. SWITCHING TO A (B)(6)8. SF BYRD DILATOR SHEATH, PROGRESS WAS MADE TO THE RA. NEXT, THE GLIDELIGHT COULD ADVANCE WITHOUT RADIATION TO RA, AND THE LV LEAD BROKE. CHANGING TO A (B) (6) 9F EVOLUTION, AND ALIGNING AXIS TO THE CORONARY SINUS, THE LEAD SEPARATED. AFTER THAT, SWITCHING TO A FEMORAL APPROACH AND RIGHT SUBCLAVIAN APPROACH, A 14F GLIDELIGHT AND OSPIKA SNARE WAS USED TO GRASP THE CONDUCTOR WIRE. THE GLIDELIGHT WAS ADVANCED WITHOU

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

  MAUDE report 23697631 ↗
• 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 ↗
• InjuryAug 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PROCEDURE WAS STARTED AFTER GRASPING THE LEAD FROM THE FEMORAL ARTERY PER RIGHT ATRIUM (RA) WITH A NEEDLE EYE'S SNARE (NES). THE REASON FOR TRACTION FROM BELOW WAS TO MAKE THE SHEATH AND LEAD COAXIAL AND EASY TO DETACH APPROACHING FROM THE UPPER EXTREMITY, AND TO REDUCE THE RISK OF SUPERIOR VENA CAVA (SVC) INJURY. FROM THE UPPER EXTREMITY, WE USED EVOLUTION SHORTIE, EVOLUTION11, AND EVOLUTION13 TO DISSECT THE CORONARY SINUS (CS), BUT THE ADHESION IN THE CS WAS SO STRONG THAT PHYSICIAN DECIDED TO SHIFT TO BYRD DILATOR SHEATH, JUDGING THAT HE COULD NOT REMOVE THE CS WITHOUT SOME DISSECTION INSIDE IT. HOWEVER, IT COULD NOT FOLLOW THE FLEXION AND KINKED. HE SWITCHED TO EVOLUTION 11 AGAIN, MAINTAINED THE SHEATH TIP NEAR THE CS, AND SLOWLY ROTATED AND APPLIED TRACTION, WHICH ALLOWED US TO REMOVE IT. IMMEDIATELY AFTERWARDS, THE BLOOD PRESSURE GRADUALLY DROPPED, PERICARDIAL FLUID ACCUMULATION WAS CONFIRMED, AND PERICARDIOCENTESIS WAS ATTEMPTED. AFTER OBSERVING THE PATIENT FOR ABOUT AN HOUR, IT WAS DETERMINED THAT THE PATIENT HAD STABILIZED AND A DECISION WAS MADE NOT TO PERFORM A THORACOTOMY.

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 22725602 ↗
• InjuryJun 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  WE REPORT A CASE IN WHICH SUPERIOR VENA CAVA (SVC) INJURY OCCURRED USING THE FOLLOWING PRODUCTS: EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET, STEADYSHEATH EVOLUTION® TISSUE STABILIZATION SHEATH, PHILIPPS/GLIDELIGHT 14FR, PHILIPPS/GLIDELIGHT 16FR, (IT IS UNCLEAR IN WHAT ORDER THE COOK PRODUCT EVOLUTION AND THE PHILIPS PRODUCT GLIDELIGHT WERE USED.) EACH ONE LEAD HAD BEEN PLACED IN THE RIGHT ATRIUM AND RIGHT VENTRICLE. AFTER REMOVAL OF THE ATRIAL LEAD, DURING DISSECTION OF THE AREA AROUND THE SVC FOR REMOVAL OF THE VENTRICULAR LEAD, THE PATIENT BLED AND BECAME HYPOTENSIVE; AN ATTEMPT WAS MADE TO STOP THE BLEEDING WITH A PHILIPPS/BRIDGE OCCULUSION BALLOON, FOLLOWED BY OPEN CHEST SURGERY, WHICH REVEALED AN INJURY OF THE SVC.

  Patient problems: Great Vessel Perforation; Low Blood Pressure/ Hypotension

  MAUDE report 22151454 ↗
• InjuryMay 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A GLIDELIGHT 14FR WAS USED FROM THE SUBCLAVIAN VEIN, BUT THERE WAS DIFFICULTY IN ADVANCING THE SHEATH, AND AT AROUND THE ANONYMOUS VEIN, THE GLIDELIGHT 14FR WAS SHIFTED TO A LR-EVN-SH-11.0-RL. AFTER PASSING THROUGH THE ANONYMOUS VEIN, THE LR-EVN-SH-11.0-RL WAS SHIFTED TO THE GLIDELIGHT 14FR. IT DID NOT ADVANCE FROM AROUND SUPERIOR VENA CAVA (SVC), RIGHT ATRIUM (RA) JUNCTION, AND THE GLIDELIGHT 14FR WAS REPLACED WITH A GLIDELIGHT 16FR. THE SHEATH WAS UNABLE TO ADVANCE FURTHER THAN AROUND THE DISTAL COIL OF A LEAD. THOUGH THE GLIDELIGHT 16FR WAS USED WITH AN OUTER SHEATH, THE SITUATION DID NOT CHANGE AT ALL, AND THE OUTER SHEATH GOT KINKED. THEN THE GLIDELIGHT 16FR WAS SHIFTED TO LR-EVN-13.0-RL AND THE REMOVAL WAS SUCCESSFULLY DONE. THE USER NOTED THE SLOW HEART MOVEMENT TO SUSPECT CARDIAC TAMPONADE. THE ECHO SHOWED PERICARDIAL FLUID WAS LEAKING, THEREFORE THE USER IMMEDIATELY PREPARED FOR DRAINAGE AND BEGAN TO SUCK IT OUT. AFTER WATCHING THE PATIENT CONDITION FOR ABOUT 60 MINUTES, THE USER AND THE SURGEONS DETERMINED THAT BLEEDING STOPPED, AND THEN SUBCUTANEOUS IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (SICD) WAS PLACED.

  Patient problems: Cardiac Tamponade; Perforation of Vessels; Pericardial Effusion

  MAUDE report 22096454 ↗
• InjuryMar 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LEAD REMOVAL WAS ATTEMPTED WITH COOK DEVICES (EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SETS AND NEEDLE¿S EYE SNARE) AND NON-COOK LASER SHEATHS (14F, 16FR). WHEN THE USER ATTEMPTED TO REMOVE A LONG-TERM PLACED ATRIAL LEAD, THE BLOOD PRESSURE DECREASED. THE USER DETERMINED THAT CARDIAC TAMPONADE OCCURRED TO OPEN THE CHEST. THE PATIENT CONDITION AFTER OPENING THE CHEST IS STABLE.

  Patient problems: Cardiac Tamponade; Low Blood Pressure/ Hypotension

  MAUDE report 21696336 ↗
• InjurySep 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER THE PROCEDURE, THE PATIENT HAD TO UNDERGO SURGERY BECAUSE OF A BLOOD HEMORRHAGE. AFTER THE SURGERY THE USER SAID THAT THE BLOOD COULD HAVE COME FROM THE VENA AND COULD HAVE BEEN CAUSED BY OUR PRODUCT. ONCE EXTRACTED ATRIAL PACEMAKER WITHOUT ANY PROBLEM DURING FIBROLISIS WITH EVOLUTION 11.0 LONG SHAFT, IT OCCURRED HEMORRHAGE (PERICARDIAL TAMPONADE). AFTER PERICARDIOCENTESIS, PATIENT HAS BEEN TRANSFERRED IN OPERATING ROOM TO CARDIAC SURGEONS THAT FOUND A SEVERE DAMAGE ON SUPERIOR VENA CAVA THAT THEY REPAIRED.

  Patient problems: Great Vessel Perforation; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20339377 ↗
• InjurySep 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHILIPS LLD #2 (LEAD LOCKING DEVICE) WAS INSERTED INTO THE STYLET LUMEN OF THE ICD LEAD AND ADVANCED TO THE TIP. 14FR GLIDELIGHT WAS INSERTED THROUGH THE PUNCTURE SITE AND DISSECTION/SEPARATION OF THE ICD LEAD WAS STARTED, BUT IT STOPPED IN THE MIDDLE OF SUBCLAVIAN VEIN. THEREFORE, THE DEVICE WAS CHANGED TO AN EVOLUTION SHORTIE RL 11FR, WHICH ALLOWED IT TO PASS THROUGH THE SUBCLAVIAN VEIN. NEXT, THE DEVICE WAS CHANGED TO AN EVOLUTION RL 11FR, AND WHILE DISSECTING JUST BEFORE THE SVC (SUPERIOR VENA CAVA), THE TIP OF THE LEAD SEEMED TO HAVE COME OFF, BUT IN FACT IT HAD NOT COME OFF, SO THE DEVICE WAS TRIED TO PROCEED WITH DISSECTION AGAIN WITH AN 11FR, BUT THE MIDDLE OF THE SVC COIL (WHERE THERE MAY BE A MASS OF ADHESION TISSUE) DID NOT ENTER THE SHEATH. THEREFORE, THE DEVICE WAS CHANGED TO AN EVOLUTION RL 13FR, BUT THE SAME PART DID NOT ENTER THE SHEATH, SO THE DEVICE WAS CHANGED TO A GLIDELIGHT 16FR, BUT THE SAME PART DID NOT ENTER THE SHEATH. WHEN A 13FR STEADY SHEATH WAS SET INSIDE THE EVOLUTION RL 13FR AND ADVANCED, THE INNER SHEATH OF THE EVOLUTION RL 13FR DID NOT PASS THE MIDDLE OF THE SVC COIL WHERE THERE MAY BE A MASS OF ADHESION TISSUE, BUT THE STEADY SHEATH PASSED THROUG

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

  MAUDE report 20309089 ↗
• 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 ↗
• DeathAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER REP - 19AUG2024 - FOUR COOK DEVICES WERE USED IN THE PROCEDURE. THEY FUNCTIONED PROPERLY AND DID NOT CONTRIBUTE TO THE ADVERSE EVENT. THE COOK DEVICES WERE USED AND THEN REMOVED. OTHER NON-COOK DEVICES WERE THEN USED. WHILE ATTEMPTING TO EXTRACT A LEAD WITH A NON-COOK DEVICE, A LEAD IN THE PATIENT BROKE CAUSING A HOLE IN THE PATIENT'S HEART. THE PATIENT HAD TO HAVE THEIR CHEST CRACKED FOR AN OPEN PROCEDURE. THE PATIENT EXPIRED OVER THE WEEKEND AFTER THE OPEN PROCEDURE.

  Patient problems: Cardiac Perforation

  MAUDE report 20040749 ↗
• InjuryAug 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT ANATOMY BEFORE SURGERY AND AT THE TIME OF FAILURE: PACEMAKER LEADS HAD BEEN PLACED IN THE RIGHT ATRIUM AND RIGHT VENTRICLE VIA THE LEFT SUBCLAVIAN VEIN RESPECTIVELY. THE RIGHT ATRIUM WAS APPROACHED VIA THE LEFT SUBCLAVIAN VEIN. WHILE REMOVING ADHESIONS NEAR THE TIP OF THE RIGHT ATRIAL LEAD USING THE LR-EVN-11.0-RL, IT WAS NOTICED THAT THE PATIENT'S HEART WAS MOVING SLOWLY, AND FLUOROSCOPIC IMAGES SUGGESTED THAT PERICARDIAL FLUID HAD ACCUMULATED. A CARDIAC SURGEON IMMEDIATELY INTERVENED AND DRAINED THE PERICARDIAL FLUID WITHOUT A THORACOTOMY. AFTER DRAINAGE AND HEART START, THE ATRIAL LEAD WAS SUCCESSFULLY REMOVED.

  Patient problems: Cardiac Perforation; Cardiac Tamponade; Pericardial Effusion

  MAUDE report 20002750 ↗
• 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 ↗
• InjuryDec 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EXTRACTION. HOLE IN ATRIAL APPENDAGE. CHEST OPENED. 2 STITCHES. PATIENT IS FINE. CAUSE OF HOLE PASSIVE LEAD. ALTHOUGH THE WHOLE EXTRACTION KIT WAS USED, THE PASSIVE LEAD CAUSED THE HOLE. THE PASSIVE LEADS CAUSED A HOLE IN THE ATRIAL APPENDAGE. NO EQUIPMENT WAS AT FAULT. PATIENT IS FINE AND RECOVERING.

  Patient problems: Cardiac Perforation; Internal Organ Perforation

  MAUDE report 18366588 ↗