Copilot 1003331Recalls & reported problems

Summary

The FDA's MAUDE database contains 189 adverse event reports that list this exact device (DI 08717648013997), received between Mar 3, 2017 and Sep 21, 2026 — classified as 3 injuries, 186 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (149 reports).

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 25 most recent of 189 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Loose or Intermittent Connection; Physical Resistance/Sticking

  It was reported that the CoPilot cap was not pushing in and the rotator was not tightening correctly to the sheath. Another device was used to continue the procedure. There were no adverse patient effects. No additional information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50841060 ↗
• MalfunctionJul 22, 2026Loose or Intermittent Connection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25909754 ↗
• MalfunctionMay 14, 2026Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING PREPARATION, THE SIDEPORT OF A COPILOT BBCV DEVICE WAS UNABLE TO BE SCREWED ONTO THE STOPCOCK. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25174142 ↗
• MalfunctionApr 9, 2026Difficult to Advance; Material Split, Cut or Torn

  IT WAS REPORTED THE PROCEDURE WAS TO IMPLANT AN AMPLATZER AMULET LEFT ATRIAL APPENDAGE OCCLUDER. THE AMULET WAS PUSHED THROUGH THE COPILOT BLEEDBACK CONTROL VALVE (BBCV) HOWEVER RESISTANCE WAS MET AND IT WAS NOTED THE O-RING INSIDE THE COPILOT WAS DISFIGURED. THE AMULET WAS REMOVED HOWEVER A PIECE OF THE O-RING WAS NOTED ON THE AMULET DEVICE. THE COPILOT WAS REPLACED WITH A NEW ONE TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24829712 ↗
• MalfunctionApr 8, 2026Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING PREP AND DURING THE PROCEDURE, THE COPILOT DEVICE WOULD NOT STAY CONNECTED TO THE SYRINGE. WHEN THE TECH TURNED THE SYRINGE ON TO THE SIDE PORT OF THE COPILOT AND LET GO, THE SYRINGE WOULD TWIST OFF AND DROP TO THE TABLE. WHEN CONNECTING THE SIDE PORT TO PRESSURE TUBING FOR INJECTIONS A LOT OF FORCE WAS NEEDED TO MAKE SURE PRESSURE TUBING WOULD STAY CONNECTED. THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24818664 ↗
• MalfunctionFeb 23, 2026Leak/Splash

  IT WAS REPORTED THAT DURING USE OF THE COPILOT, BUBBLES WERE NOTED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24421715 ↗
• MalfunctionFeb 23, 2026Leak/Splash

  IT WAS REPORTED THAT DURING USE OF THE COPILOT, BUBBLES WERE NOTED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24420638 ↗
• MalfunctionFeb 12, 2026Loose or Intermittent Connection

  IT WAS REPORTED THE COPILOT BLEEDBACK CONTROL VALVE (BBCV) WAS BLOCKED AT THE SCREW THREAD. THIS ISSUE OCCURRED WITH TWO DEVICES. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24324334 ↗
• MalfunctionFeb 12, 2026Loose or Intermittent Connection

  IT WAS REPORTED THE COPILOT BLEEDBACK CONTROL VALVE (BBCV) WAS BLOCKED AT THE SCREW THREAD. THIS ISSUE OCCURRED WITH TWO DEVICES. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24324283 ↗
• MalfunctionJan 2, 2026Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE COPILOT WAS USED IN THE PROCEDURE. WHEN THE PROCEDURE WAS COMPLETED, IMPURITIES WERE NOTED IN THE DEVICE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23945737 ↗
• MalfunctionSep 12, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE COPILOT DEVICE LEAKED DURING CONTRAST AGENT INJECTIONS FROM THE BLEEDBACK CONTROL SEAL. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER COPILOT WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23042491 ↗
• InjuryJun 17, 2025Leak/Splash; Leak/Splash

  USER FACILITY MEDWATCH REPORT RECEIVED THAT STATES "PATIENT WAS BROUGHT FOR AN ELECTIVE LAA [LEFT ATRIAL APPENDAGE] OCCLUSION DEVICE. TRANSSEPTAL PUNCTURE PERFORMED. TRANSSEPTAL SHEATH EXCHANGED FOR DEVICE SHEATH. DEVICE SHEATH USES A DEVICE CALLED A COPILOT BLEEDBACK CONTROL VALVE. THE COPILOT BLEEDBACK CONTROL VALVE WAS FOUND TO BE DEFECTIVE. WHEN BLOOD WAS DRAWN BACK, THE BLEEDBACK VALVE INTRODUCED AIR TO THE DEVICE SHEATH, WHICH ULTIMATELY DELIVERED AIR TO THE LEFT ATRIUM, WHICH BROUGHT AIR TO THE CORONARY ARTERIES. TROUBLESHOOTING MANEUVERS WERE PERFORMED, AND ST ELEVATION RESOLVED, WITH THE PATIENT EVENTUALLY BEING SENT TO THE ICU [INTENSIVE CARE UNIT]. USED A MANUAL TUOHY." SUBSEQUENT TO THE MEDWATCH REPORT, IT WAS REPORTED THAT ONE DEVICE WAS IN THE COPILOT BBCV WHEN THE LEAK WAS NOTED. OXYGEN WAS ADMINISTERED TO THE PATIENT TO RESOLVE THE EKG CHANGES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Air Embolism; Non specific EKG/ECG Changes

  MAUDE report 22234199 ↗
• MalfunctionMay 30, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT CORONARY ARTERY (RCA) WITH MODERATE CALCIFICATION, MODERATE TORTUOSITY AND 90% STENOSIS. THE COPILOT WAS USED IN THE PROCEDURE BUT THERE WAS POOR VALVE CLOSURE AND BLOOD LEAKAGE. A NON-ABBOTT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22118797 ↗
• MalfunctionApr 22, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY CALCIFIED LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. DURING THE USE OF THE COPILOT BLEEDBACK CONTROL VALVE (BBCV ), CONTRAST WAS NOTED TO BE LEAKING FROM THE CAP OF THE BBC AS WELL AS PRESSURE WAS NOTED TO BE LOST. THEREFORE, THE CAP WAS TIGHTENED AND THE LEAK WAS NOTED TO SUBSIDE, AND THE SAME BBCV WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS NOR CLINICAL DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21883939 ↗
• MalfunctionApr 14, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE COPILOT BLEED BACK CONTROL VALVE (BBCV) WAS BEING USED IN THE DIAGNOSTIC PROCEDURE; HOWEVER, THE VALVE WAS NOTED TO LEAKING SALINE AND BLOOD FROM THE ROTOR OF THE DEVICE. THE PROCEDURE WAS COMPLETED WITH THE DEVICE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21835342 ↗
• MalfunctionMar 27, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A RIGHT CORONARY ARTERY. THE COPILOT BLEEDBACK CONTROL VALVE WAS NOTED TO HAVE CONSTANT AIR GETTING INTO SYRINGE WHEN DRAWING BACK ON THE SYRINGE. THE SAME DEVICE WAS USED THROUGHOUT THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21712408 ↗
• MalfunctionMar 21, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE COPILOT VALVE WAS CLOSED AND DID NOT LOCK PROPERLY AND WAS NOTED TO LEAK. THE WIRE DID NOT MOVE OR STAY FIXED. ANOTHER COPILOT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21667698 ↗
• MalfunctionMar 21, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE COPILOT WAS LEAKING BLOOD FROM THE BLEEDBACK CONTROL VALVE DURING USE. THE DEVICE WAS CONNECTED TO A CATHETER, BALLOON AND WIRE. THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21665758 ↗
• MalfunctionMar 18, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE COPILOT WAS LEAKING WHEN CONNECTED TO AN UNSPECIFIED DEVICE AND WHEN THE DEVICE WAS TAKEN OUT. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21632996 ↗
• MalfunctionMar 6, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN AN UNSPECIFIED CORONARY ARTERY. THE COPILOT BLEED BACK CONTROL VALVE (BBCV) WAS USED IN THE PROCEDURE, HOWEVER, A LEAK WAS OBSERVED AT THE HEMOSTATIC VALVE ALTHOUGH THE SEAL WAS CLOSED. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21540134 ↗
• MalfunctionMar 6, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN AN UNSPECIFIED CORONARY ARTERY. THE COPILOT BLEED BACK CONTROL VALVE (BBCV) WAS USED IN THE PROCEDURE, HOWEVER, A LEAK WAS OBSERVED AT THE HEMOSTATIC VALVE ALTHOUGH THE SEAL WAS CLOSED. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21539932 ↗
• MalfunctionFeb 20, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE COPILOT WAS NOTED TO BE LEAKING BLOOD, MAKING IT DIFFICULT FOR THE PHYSICIAN TO MANIPULATE THE DEVICES AND HAVE VISIBILITY ON ALL THE DEVICES. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21420730 ↗
• MalfunctionJan 30, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE COPILOT DEVICE WAS USED DURING THE PROCEDURE. THE PHYSICIAN FOUND THAT BLOOD FLOWED BACK EVEN WHEN IT WAS LOCKED. IT CONTINUED AFTER THE GUIDEWIRE WAS INSERTED, AND THE SITUATION REMAINED EVEN WHEN ADDITIONAL DEVICES WERE INSERTED. A SECOND COPILOT DEVICE WAS USED BUT HAD THE SAME ISSUE. THE PHYSICIAN USED A THIRD NEW COPILOT, BUT IT ALSO DID NOT WORK PROPERLY. THE SAME ISSUE OCCURRED WITH THE THREE COPILOT DEVICES. THE PROCEDURE WAS COMPLETED WITH A FOURTH, NEW COPILOT DEVICE, AND NO PATIENT ADVERSE EVENTS WERE REPORTED. HOWEVER, THE USER WAS VERY UPSET. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21275979 ↗
• MalfunctionJan 30, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE COPILOT DEVICE WAS USED DURING THE PROCEDURE. THE PHYSICIAN FOUND THAT BLOOD FLOWED BACK EVEN WHEN IT WAS LOCKED. IT CONTINUED AFTER THE GUIDEWIRE WAS INSERTED, AND THE SITUATION REMAINED EVEN WHEN ADDITIONAL DEVICES WERE INSERTED. A SECOND COPILOT DEVICE WAS USED BUT HAD THE SAME ISSUE. THE PHYSICIAN USED A THIRD NEW COPILOT, BUT IT ALSO DID NOT WORK PROPERLY. THE SAME ISSUE OCCURRED WITH THE THREE COPILOT DEVICES. THE PROCEDURE WAS COMPLETED WITH A FOURTH, NEW COPILOT DEVICE, AND NO PATIENT ADVERSE EVENTS WERE REPORTED. HOWEVER, THE USER WAS VERY UPSET. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21275930 ↗
• MalfunctionJan 30, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE COPILOT DEVICE WAS USED DURING THE PROCEDURE. THE PHYSICIAN FOUND THAT BLOOD FLOWED BACK EVEN WHEN IT WAS LOCKED. IT CONTINUED AFTER THE GUIDEWIRE WAS INSERTED, AND THE SITUATION REMAINED EVEN WHEN ADDITIONAL DEVICES WERE INSERTED. A SECOND COPILOT DEVICE WAS USED BUT HAD THE SAME ISSUE. THE PHYSICIAN USED A THIRD NEW COPILOT, BUT IT ALSO DID NOT WORK PROPERLY. THE SAME ISSUE OCCURRED WITH THE THREE COPILOT DEVICES. THE PROCEDURE WAS COMPLETED WITH A FOURTH, NEW COPILOT DEVICE, AND NO PATIENT ADVERSE EVENTS WERE REPORTED. HOWEVER, THE USER WAS VERY UPSET. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21275927 ↗