PASCAL PRECISION 20000GSARecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00690103216967), received between Feb 23, 2024 and Apr 10, 2026 — classified as 1 death, 12 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (9 reports).

1 other recall cover devices cleared under the same FDA submission (P220003); they may or may not involve this specific model.

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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 10, 2026Air/Gas in Device

  EDWARDS RECEIVED NOTIFICATION OF A PASCAL IN MITRAL PROCEDURE WHERE AFTER CROSSING THE SEPTUM, BEFORE REMOVAL OF INTRODUCER AND WIRE, AIR WAS VISUALIZED IN LA (LEFT ATRIUM) AND AORTA ON TTE (TRANSESOPHAGEAL ECHOCARDIOGRAM). THE PHYSICIAN DECIDED TO REMOVE THE GUIDE SHEATH AND CANCEL THE CASE. THE PATIENT HAD NO HEMODYNAMIC CHANGES. THE PATIENT WOKE UP FROM ANESTHESIA WITHOUT ANY EFFECTS. THE CASE WILL BE RESCHEDULED. THERE WERE NO CONCERNS WITH THE GUIDE SHEATH DURING PREP. ROOT CAUSE OF AIR IS UNDETERMINED. THE GUIDE SHEATH WAS DISCARDED.

  Patient problems: Air Embolism

  MAUDE report 24845271 ↗
• InjuryMar 19, 2026Difficult to Insert

  EDWARDS RECEIVED NOTIFICATION OF A PASCAL IN MITRAL PROCEDURE WHERE THE PATIENT HAD A LOWER TSP (TRANSSEPTAL PUNCTURE). GAIN HEIGHT MANEUVER WAS REQUIRED WHICH OPENED THE SEPTAL PUNCTURE TO REVEAL RIGHT-TO-LEFT SHUNT. THE PATIENTS O2 SATURATION DROPPED WITH THIS MANEUVER. WITH THE RELEASE OF ANOTHER MANUFACTURERS AORTIC OCCLUSION DEVICE, THE PATIENTS SATURATION RETURNED TO BASELINE. THE PROCEDURE COMPLETED, AND MR (MITRAL REGURGITATION) WAS REDUCED FROM SEVERE TO MILD. THE PHYSICIAN PROCEEDED WITH THE DECISION TO CLOSE THE (ASD) ATRIAL SEPTAL DEFECT AFTER THE PROCEDURE. THE ATRIAL SEPTAL DEVICE WAS SUCCESSFULLY PLACED.

  Patient problems: Cardiac Perforation

  MAUDE report 24643496 ↗
• InjuryJan 29, 2026Difficult to Insert

  EDWARDS RECEIVED NOTIFICATION OF A PASCAL IN MITRAL PROCEDURE WHERE THE IMPLANT WAS OPENED BUT NOT ATTEMPTED. DURING THE PROCEDURE, WHEN THE GS (GUIDE SHEATH) WAS INTRODUCED AND THE PASCAL DEVICE INTRODUCED INTO THE GS, A PERICARDIAL EFFUSION WAS NOTICED WHICH PROGRESSED TO CARDIAC TAMPONADE. THERE WAS NO EFFUSION / CARDIAC TAMPONADE NOTED BEFORE THE INSERTION OF THE GS. DURING TRANSSEPTAL PROCEDURE, THE WIRE WAS NOTED AS DIFFICULT TO ADVANCE, AND THE TEAM COULD NOT CONFIRM WHERE THEY WERE (LUPV VS RUPV). IMAGING WAS ALSO DIFFICULT AS IC WAS INSTRUCTED TO GO MORE POSTERIOR, AND A PUNCTURE WAS MADE THROUGH THE SEPTAL TRIGONE. PERICARDIOCENTESIS WAS PERFORMED. PATIENT WAS THEN SURGICALLY OPENED, AND IN SURGERY, BLEEDING HAD STOPPED REQUIRING NO SURGICAL REPAIR, ONLY EVACUATION OF THE CLOTTED MATERIAL. THE PASCAL PROCEDURE WAS ABORTED. THE MR (MITRAL REGURGITATION) REMAINED SEVERE. THE PATIENT IS STABLE. A PLAN FOR REINTERVENTION IS UNKNOWN.

  Patient problems: Cardiac Perforation

  MAUDE report 24210211 ↗
• InjuryJan 29, 2026Device Damaged by Another Device

  EDWARDS RECEIVED NOTIFICATION OF A PASCAL IN MITRAL PROCEDURE WHERE THE IMPLANT WAS ATTEMPTED BUT ABORTED. THE PATIENT HAS A PFO (PATENT FORAMEN OVALE). AN ASD (ATRIAL SEPTAL DEFECT) CLOSURE DEVICE WAS PLACED 5 DAYS PRIOR TO THE PROCEDURE. DURING THE PASCAL PROCEDURE, THE PHYSICIAN ELECTED TO GO POSTERIOR TO THE CLOSURE DEVICE AND CROSSED AT THE PFO. IT IS BELIEVED AS THE PFO WAS CROSSED AND GS (GUIDE SHEATH) FLEX ADDED, TO GET POSTERIOR AND GAIN HEIGHT, THE SUPERIOR PORTION OF THE ASD WAS DISLODGED. THIS MAY HAVE CAUSED INCREASED SHUNTING ACROSS THE SEPTUM CAUSING THE PATIENT TO BECOME UNSTABLE. THE PATIENT WAS DESATURATING AS THE PHYSICIAN ATTEMPTED ONE GRASP WITH THE PASCAL DEVICE AT A2P2 AND WAS UNABLE TO OPTIMIZE THE POSITION AND ORIENTATION. TO STABILIZE THE PATIENT, THE PHYSICIAN ELECTED TO BAILOUT THE DEVICE AND REPAIR THE SEPTUM WITH AN ADDITIONAL CLOSURE DEVICE, SUPPORTING THE ORIGINAL DEVICE AND ENCOMPASSING THE PFO. THE PATIENT WAS ALSO PLACED ON A BALLOON PUMP AND ECMO (EXTRACORPOREAL MEMBRANE OXYGENATION) FOR FURTHER STABILIZATION. MR (MITRAL REGURGITATION) REMAINED SEVERE.

  Patient problems: Cardiac Perforation

  MAUDE report 24210090 ↗
• InjuryJan 16, 2026Air/Gas in Device

  EDWARDS RECEIVED NOTIFICATION OF A PASCAL IN MITRAL PROCEDURE WHERE AIR WAS INTRODUCED INTO THE PATIENT. NOTED WAS A DROP IN PRESSURES WITH THE INSERTION OF THE GUIDE. ST ELEVATION AFTER FLUSH WITH IMPLANT SYSTEM INSERTION. IC (IMPLANTING CARDIOLOGIST) MENTIONED AN AIR BUBBLE LIKELY GOT INTO THE CORONARIES HENCE THE REASON HE CATHED THE ARTERIES TO ENSURE THEY WERE NOT BLOCKED. THE PATIENT HAD A VASOVAGAL EVENT WITH INSERTION OF GUIDE SHEATH WHICH, AS THE IC EXPLAINED, THE BUBBLES TEND TO GET PULLED INTO THE CORONARIES WITH THE DROP IN PRESSURES. O2 WAS ADMINISTERED. A CORONARY ANGIOGRAM REVEALED NO BLOCKAGE, YET SIGNIFICANT CAD DEMONSTRATED. ST ELEVATION RESOLVED BEFORE RESUMING PROCEDURE AND THERE WAS NO ST ELEVATION DURING THE PROCEDURE. COMMENTS WERE MADE OF POSSIBLY LOWER LVEF POST-PROCEDURE, YET NOTHING SIGNIFICANT. THE PROCEDURE WAS COMPLETED. MR (MITRAL REGURGITATION) REDUCTION TO MILD WAS ACHIEVED. THE PATIENT IS STABLE.

  Patient problems: Air Embolism

  MAUDE report 24098875 ↗
• InjuryJan 9, 2026Difficult to Insert; Air/Gas in Device

  EDWARDS RECEIVED NOTIFICATION OF A PASCAL IN MITRAL PROCEDURE. ONCE THE FIRST GUIDE SHEATH WAS POSITIONED ACROSS THE LEFT ATRIUM, THE IMPLANT WAS INSERTED THROUGH THE SEALS USING THE LOADER. ASPIRATION WAS ATTEMPTED, BUT A SIGNIFICANT AMOUNT OF AIR APPEARED IN THE SYRINGE AND WAS ALREADY PRESENT IN THE HEART. ASPIRATION WAS STOPPED, AND THE GUIDE SHEATH WAS PULLED BACK INTO THE RIGHT ATRIUM. DESPITE NO FURTHER ASPIRATION AT THAT POINT, AIR CONTINUED TO ENTER THE HEART. AN ATRIAL SEPTAL DEFECT (ASD) WITH A RIGHT TO LEFT SHUNT HAD BEEN NOTED PRE PROCEDURE, RESULTING IN HYPOXIC BLOOD PASSING INTO THE LEFT ATRIUM. AIR WAS PRESENT IN THE RIGHT ATRIUM AND RIGHT VENTRICLE AND CROSSED THE SEPTUM INTO THE LEFT ATRIUM. THE PATIENT DEVELOPED VENTRICULAR TACHYCARDIA, WITH AIR IDENTIFIED IN THE CORONARIES. THE PHYSICIAN ALLEVIATED THE AIR BURDEN BY ASPIRATING THROUGH A SEPARATE ACCESS/PIGTAIL, AND CARDIOVERSION WAS REQUIRED. ONCE ALL AIR WAS REMOVED AND THE PATIENT WAS STABLE, THE ENTIRE SYSTEM WAS WITHDRAWN, AND A NEW GUIDE SHEATH AND IMPLANT WERE PREPARED. THE RIGHT TO LEFT SHUNT/ASD WAS TREATED WITH A CLOSURE DEVICE. THE PROCEDURE WAS COMPLETED. MR (MITRAL REGURGITATION) WAS REDUCED FROM SEV

  Patient problems: Air Embolism; Cardiac Perforation

  MAUDE report 24026432 ↗
• InjuryNov 3, 2025Difficult to Insert; Difficult to Insert

  EDWARDS RECEIVED NOTIFICATION OF A PASCAL IN MITRAL PROCEDURE WHERE THERE WERE CHALLENGING IMAGING WINDOWS DUE TO ANATOMICAL SHADOWING AND SMALL FOSSA OVALIS. A SMALL PE (PERICARDIAL EFFUSION) WAS NOTED DURING PLACEMENT OF FIRST ACE IMPLANT. THE PE CONTINUED TO GET PROGRESSIVELY BIGGER. PROCEEDED WITH SECOND ACE IMPLANT AND ACHIEVED OPTIMAL MR (MITRAL REGURGITATION) REDUCTION. THE PE CONTINUED TO GET WORSE, AND THE PATIENT BECAME HYPOTENSIVE WHICH REQUIRED PERICARDIOCENTESIS. PATIENT WAS STABILIZED.

  Patient problems: Cardiac Perforation

  MAUDE report 23457672 ↗
• MalfunctionMay 22, 2025Air/Gas in Device; Air/Gas in Device

  EDWARDS RECEIVED NOTIFICATION OF A PASCAL IN MITRAL POSITION WHERE AN IMPLANT WAS ATTEMPTED BUT ABORTED BECAUSE THE PHYSICIAN DECIDED TO REMOVE THE IMPLANT WHEN ECHOCARDIOGRAPHIC EVIDENCE OF AIR BUBBLES WERE PRESENT. THE PATIENT WAS STABLE THROUGHOUT THE PROCEDURE IN SPITE OF THE OPERATOR'S CONCERNS ABOUT THE ECHOCARDIOGRAPHIC EVIDENCE OF AIR BUBBLES IN THE LEFT ATRIUM WHILE STEERING THE IMPLANT TO THE MITRAL VALVE. THE PHYSICIAN DECIDED TO BAILOUT THE IMPLANT BEFORE LEAFLET CAPTURE WAS ATTEMPTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A REDUCTION IN MR FROM SEVERE TO MILD. PER INTERNAL IMAGING REVIEW OF INTRAPROCEDURAL TEE IMAGING, THERE APPEARS TO BE SMALL MOBILE AIR BUBBLES EMERGING FROM THE GS (GUIDE SHEATH) TIP WHEN FIRST VISUALIZED ACROSS THE INTRA-ATRIAL SEPTUM. IN SUBSEQUENT IMAGING, AIR IS NO LONGER OBSERVED. AT THE TIME OF IMPLANT RELEASE OF BOTH OF THE PASCAL DEVICES, AIR INTRODUCTION OCCURRED. SMALL MOBILE AIR BUBBLES WERE ALSO OBSERVED DURING RELEASE OF THE IMPLANTS. THE BUBBLES WERE OBSERVED IN THE LEFT ATRIUM, LEFT VENTRICLE AND THE AORTA. THE SOURCE OF BUBBLES APPEARS TO BE AT THE JUNCTION OF THE PROXIMAL PORTION OF THE IMPLANT AND THE DISTAL PORTION OF THE I

  Patient problems: Air Embolism

  MAUDE report 22074080 ↗
• InjuryMay 19, 2025Difficult to Insert; Difficult to Insert

  PER REPORT RECEIVED FROM JAPAN- EDWARDS RECEIVED NOTIFICATION OF A PASCAL PRECISION IN MITRAL POSITION WHERE AFTER THE SURGERY, THE SEPTAL DIAMETER WAS RELATIVELY LARGE, BUT THERE WERE NO PROBLEMS WITH OXYGENATION. A SEPTAL CLOSURE WAS PERFORMED AT ANOTHER HOSPITAL.

  Patient problems: Cardiac Perforation

  MAUDE report 22044289 ↗
• MalfunctionDec 23, 2024Air/Gas in Device; Air/Gas in Device

  EDWARDS RECEIVED NOTIFICATION OF A PASCAL IN MITRAL POSITION WHERE IT WAS REPORTED THAT A HIGHER AMOUNT OF BUBBLES WERE NOTICED BEING INTRODUCED INTO THE LA WHEN ADVANCING THE STEERABLE/IMPLANT CATHETERS INTO THE LA. A NEW GUIDE SHEATH WAS USED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Air Embolism

  MAUDE report 21000945 ↗
• InjuryNov 15, 2024Air/Gas in Device; Air/Gas in Device

  EDWARDS RECEIVED NOTIFICATION OF A PASCAL IN MITRAL POSITION WHERE DURING ASPIRATION OF THE GUIDE SHEATH JUST AFTER INSERTION INTO LA AND REMOVAL OF DILATOR WITH WIRE, ST DEPRESSION WAS NOTED ON THE PATIENTS ECG, NOTING A POSSIBLE AIR EMBOLUS. FIO2@100% WAS ADMINISTERED AND ST CHANGES RESOLVED IN APPROXIMATELY 2 MINUTES. NO FURTHER PATIENT COMPLICATION WAS NOTED DUE TO THIS EVENT.

  Patient problems: Air Embolism

  MAUDE report 20694903 ↗
• InjuryAug 15, 2024Difficult or Delayed Positioning; Positioning Failure; Difficult or Delayed Positioning; Positioning Failure

  EDWARDS RECEIVED NOTIFICATION OF A PASCAL IN MITRAL POSITION WHERE THERE WERE CHALLENGES WITH THE GUIDE SHEATH (GS). IT WAS UNABLE TO CORRECT FOR A-P TRAJECTORY AND GAIN HEIGHT AS NEEDED DESPITE HAVING ADEQUATE GS ACCESS. PATIENT DID HAVE A HORIZONTAL HEART, HAD TO PLACE THE PATIENT IN A SLIGHT LEFT LATERAL DECUBITIS POSITION. ALSO SUSPECTED POSSIBLE TORTUOUS ANATOMY. THE PHYSICIAN ASKED TO HAVE THE GUIDE SHEATH EVALUATED. THE SYSTEM WAS RESET BUT THE ISSUE PERSISTED DESPITE ADEQUATE GS INSERTION. THE PROCEDURE WAS COMPLETED WITH 1 PASCAL AND MR (MITRAL REGURGITATION) WAS REDUCED FROM SEVERE TO MODERATE/SEVERE. ADDITIONAL INFORMATION RECEIVED FROM THE CS (CLINICAL SPECIALIST) STATED THAT THERE WAS SOME DISCUSSION ON THE UNRESPONSIVENESS OF THE GS. THE PHYSICIAN ALSO FELT THAT DUE TO THE WIDE AP GAP, WE MAY HAVE HAD MORE TENSION OF THE POSTERIOR LEAFLET AND POTENTIALLY A SIDE BITE OF THE LEAFLET THAT WE WERE NOT ABLE TO APPRECIATE. THERE WAS DISCUSSION THAT THE PATIENT MAY BE BROUGHT BACK AT A LATER DATE FOR REINTERVENTION. THE CS INSPECTED THE GS WITH THE IS STILL INSERTED ON THE BACK TABLE. THE SYSTEM WAS INTACT, HE DID OBSERVE SOME GS CATHETER BOWING/CURVATURE OF THE MID TO PROXI

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 19991529 ↗
• InjuryJul 11, 2024Difficult to Insert; Difficult to Insert

  EDWARDS RECEIVED NOTIFICATION OF A PASCAL IN MITRAL POSITION WHERE THERE WAS SUBVALVULAR GROWING EFFUSION NOTED. THE PROCEDURE WAS ABORTED FOR PERICARDIAL DRAIN. IT WAS UNKNOWN IF THE EFFUSION CAME FROM THE WIRE OR THE INTRODUCER. MID-PROCEDURE THERE WAS GROWING EFFUSION NOTED. THE PATIENT REQUIRED ADDITIONAL HEMODYNAMIC SUPPORT. PERICARDIAL DRAIN WAS PLACED, AND CELL SAVER TRANSFUSION OCCURRED. THE PATIENT WAS GIVEN 40MG OF PROTAMINE. THE CAUSE WAS UNKNOWN- LIKELY DUE TO THE WIRE IN APPENDAGE OR INTRODUCER NEAR THE APPENDAGE. THE EFFUSION WAS FIRST NOTICED WHEN STEERING DOWN TO THE VALVE. THE PATIENT REQUIRED INCREASING AMOUNT OF HEMODYNAMIC SUPPORT FOR BLOOD PRESSURE. IT LED TO CARDIAC TAMPONADE AND A PERICARDIAL DRAIN WAS PLACED. AS PER MEDICAL OPINION, THE PERCEIVED ROOT CAUSE OF THE EVENT WAS PUNCTURE TO THE LEFT ATRIAL APPENDAGE. THE PATIENT REMAINED IN THE HOSPITAL OVERNIGHT, REVERSAL OF HEPARIN WITH PROTAMINE, AND THE DRAIN WAS REMOVED NEXT DAY.

  Patient problems: Cardiac Perforation; Cardiac Tamponade; Hemodynamic instability

  MAUDE report 19722607 ↗
• InjuryJul 11, 2024Difficult to Insert; Difficult to Insert

  EDWARDS RECEIVED NOTIFICATION OF A PASCAL IN MITRAL POSITION WHERE 3 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT DIED. THE PATIENT HAD RECEIVED TWO P10 DEVICES 3 MONTHS AGO. THE PATIENT HAD LEFT THE PROCEDURE WITH A MILD MR (MITRAL REGURGITATION) AND A GRADIENT OF 5MMHG. SHORTLY AFTER, THE PATIENT'S GRADIENT WENT UP TO 11MMHG AND THE MR INCREASED TO MODERATE/SEVERE. THERE WAS NO CHANGE TO THE IMPLANT POSITION FROM POST PROCEDURE PER FOLLOW UP IMAGING. THE PATIENT WAS SUBSEQUENTLY HOSPITALIZED AND TREATED FOR HEART FAILURE WITH DIURETICS. A LARGE ASD (ATRIAL SEPTAL DEFECT) WITH LEFT TO RIGHT SHUNTING WAS ALSO REPAIRED ABOUT A MONTH AFTER THE PASCAL WITH LITTLE CHANGE IN PATIENT STATUS. ULTIMATELY, THE PATIENT WAS PUT ON COMFORT CARE AND EXPIRED OVER THE WEEKEND FROM HER HEART FAILURE.

  Patient problems: Cardiac Perforation

  MAUDE report 19721926 ↗
• DeathJul 1, 2024Difficult to Insert; Difficult to Insert

  EDWARDS RECEIVED NOTIFICATION FROM THE IMPLANT PATIENT REGISTRY TEAM OF A PASCAL IN MITRAL POSITION WHERE THE PATIENT WAS DECEASED. ADDITIONAL INFORMATION RECEIVED STATED THAT THE PATIENT WAS VERY SICK WITH VERY POOR ANATOMY. THE PROCEDURE WAS DELAYED 30 MINUTES ONCE THE ANESTHESIOLOGIST SAW THE PATIENT HABITUS AND CLINICAL STATUS AND WENT OUT TO TALK TO THE FAMILY TO TRY AND DISSUADE THEM FROM PROCEEDING. THE PATIENT WAS REFUSED BY ABBOTT DUE TO CONCERNS ABOUT TRANSSEPTAL PUNCTURE (TSP) HEIGHT AND VASCULAR ACCESS SIZE. THE TEAM DID NOT EXPECT A GREAT RESULT BUT INFORMED THE PHYSICIAN THAT THEY COULD SAFELY TRY BUT WOULD LIKELY NOT GET ANYTHING BETTER THAN A 2+ RESULT. THE PROCEDURE LASTED NEARLY 2 HOURS FROM GS (GUIDE SHEATH) IN TO GS OUT AND THE TEAM ATTEMPTED MANY DIFFERENT POSITIONS BUT DUE TO POSTERIOR MITRAL ANNULAR CALCIFICATION, THERE JUST WAS NOT SUFFICIENT LEAFLET TO CAPTURE AND THEY WERE COMPELLED TO PLACE AND LEAVE THE DEVICE ON LATERAL A2/P2 (THE PRIMARY JET ON WORKUP WAS MEDIAL A2/P2) WHERE THEY GOT A 2 GRADE REDUCTION IN MR (MITRAL REGURGITATION) AND CUT THE LEFT ATRIUM PRESSURE IN HALF FROM 30 TO 15. THE PHYSICIAN AND TEAM WERE PLEASED WITH THE RESULT AND FELT THAT

  Patient problems: Cardiac Perforation; Hemodynamic instability

  MAUDE report 19650928 ↗
• InjuryApr 19, 2024Difficult to Insert; Difficult to Insert

  EDWARDS RECEIVED NOTIFICATION OF A PASCAL IN MITRAL POSITION WHERE ONE IMPLANT HAD CHORDAL ENTANGLEMENT AND THEN WAS ABORTED. ANOTHER IMPLANT WAS THEN USED WHICH LED TO AN ACTUATION WIRE BREAK DURING PROCEDURE, BUT THE DEVICE WAS SUCCESSFULLY REMOVED WITHOUT PATIENT INJURY. THIS DEVICE WAS ALSO ABORTED DUE TO THE WIRE BREAK. IT WAS ABLE TO BAILOUT SAFELY AND REPLACE BOTH GUIDE AND ACE WITH A NEW SYSTEM. A THIRD NEW DEVICE WAS THEN SUCCESSFULLY IMPLANTED. ADDITIONAL INFORMATION RECEIVED STATED THAT THE DEVICE WAS UNDER A LOT OF TENSION DUE TO THE FACT THAT THE TEAM WERE INTERACTING WITH SO MANY CHORDAE. IT WAS NOTICED THERE WAS AN ISSUE WHEN THE DEVICE LOOKED AS IF IT WAS DISCONFIGURED WITH DIFFERENT PADDLE FLEXING. INITIALLY IT WAS THOUGHT THAT THE DEVICE HAD AN ISSUE BUT THEN THE ACTUATION WIRE BREAK WAS NOTICED. THERE WAS A RESIDUAL BIDIRECTIONAL SHUNT AND THE PATIENT HAD HEMODYNAMIC INSTABILITY. THE SHUNT WAS CLOSED OFF DURING THE INITIAL PROCEDURE ITSELF. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND MR WAS REDUCED FROM SEVERE TO MILD.

  Patient problems: Cardiac Perforation; Hemodynamic instability

  MAUDE report 19144456 ↗
• MalfunctionFeb 23, 2024Air/Gas in Device; Air/Gas in Device

  EDWARDS RECEIVED NOTIFICATION OF A PASCAL IN MITRAL PROCEDURE WHERE THE GUIDE SHEATH WAS ASPIRATING AIR BUBBLES AFTER INSERTION OF THE IMPLANT PAST SEALS AND LOADER REMOVED. IT WAS VERIFIED THAT THE DEVICE WAS OFF ANATOMY AND EVEN MADE SMALL MOVEMENTS TO THE GUIDE ADDING FLEX AND RETRACTING AS WELL AS ADVANCING. THE GUIDE SHEATH WAS REMOVED, AND NEW GUIDE SHEATH PREPPED AND USED WITH THE SAME ISSUE- THERE WAS AIR WHILE ASPIRATING. SAME MITIGATION TECHNIQUES WERE USED BUT ANOTHER SHEATH WAS UNAVAILABLE, SO THE PROCEDURE WAS CONTINUED AS NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18767855 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P220003. One submission often covers many models, so check the product and lot details in each record.

• Z-2479-2023 · Jul 27, 2023 · Open, Classified
  PASCAL Precision Transcatheter Valve Repair System, Models: 20000ISM and 20000IS