PASCAL 20000ISRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00690103216943), received between Dec 22, 2022 and Nov 24, 2025 — classified as 1 death, 10 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (5 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryNov 24, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  EDWARDS RECEIVED NOTIFICATION OF A PASCAL IN MITRAL PROCEDURE WHERE AN IMPLANT WAS ATTEMPTED AND ABORTED DUE TO CHORDAE DAMAGE WHEN ATTEMPTING TO CAPTURE THE LEAFLET. NOTED WERE ANATOMICAL AND PROCEDURAL CHALLENGES DUE TO MEDIAL COMMISSURE LOCATION, POSTERIOR CALCIUM RIDGE BEING PRESENT, AND DENSE CHORDAL REGIONS. MR (MITRAL REGURGITATION) WAS SEVERE AT THE BEGINNING OF THE PROCEDURE AND SEVERE AFTER THE CHORDAE DAMAGE. HIGH GRADIENT (10 MMHG) WAS NOTED. MR SEVERITY WAS NOT REDUCED. THE DEVICE WAS BAILED OUT. THE PATIENT WAS SENT TO ATRIAL SURGICAL REPAIR IN THE AFTERNOON WHERE THE MV WAS REPLACED WITH BIO PROSTHETIC 27MM MITRAL VALVE. SURGERY CONFIRMED CHORDAE WAS INTACT, BUT THERE WERE 2 PERFORATIONS ON THE PML JUST ABOVE A PROMINENT CA++ RIDGE (P3 SEGMENT). THE PATIENT IS RECOVERING WELL. NO IMAGING IS AVAILABLE FOR REVIEW.

  Patient problems: Cusp Tear

  MAUDE report 23638630 ↗
• InjuryMay 13, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  EDWARDS RECEIVED NOTIFICATION OF A PASCAL PRECISION ACE IN MITRAL POSITION WHERE THE PATIENT HAD A SUSPECTED STROKE ON POST-OPERATIVE DAY (POD) 1. FROM STEERING DOWN TO THE FIRST LEAFLET CAPTURE WENT VERY SMOOTHLY. HOWEVER, THERE WAS A RESIDUAL JET FROM THE LATERAL SIDE OF THE IMPLANT. GRASPING WAS DONE A TOTAL OF 5 TIMES TO ADJUST THE CAPTURE POSITION. NO DAMAGE WAS FOUND TO THE LEAFLETS IN AN INJURY CHECK. A SIXTH GRASP WAS DONE WITH THE FINAL IDEA OF CHANGING THE TRAJECTORY FROM LATERAL TO MEDIAL, BUT THE RESULT WAS UNCHANGED. A DECISION WAS MADE TO BAILOUT THE P5 DEVICE AND CHANGE TO A P10 DEVICE. THE RESIDUAL MR DID NOT SEEM TO HAVE CHANGED MUCH, BUT THERE WAS A CLEAR IMPROVEMENT IN HEMODYNAMICS. THERE WAS CONCERN ABOUT HEMOLYSIS DUE TO THE BULKY CALCIFICATION ON THE LEAFLET AND THE IMPLANT, BUT THIS SEEMED A LIMIT OF M-TEER, SO THE IMPLANT WAS RELEASED. THE RESIDUAL MR WAS MILD TO MODERATE. THE HEART TEAM WAS VERY SATISFIED WITH THE PASCAL PROCEDURE. HOWEVER, A SUSPECTED STROKE WAS OBSERVED ON POD 1. ADDITIONAL INFORMATION WAS RECEIVED STATING IT WAS ISCHEMIC CEREBRAL INFARCTION. ACT LEVEL WAS 275 JUST BEFORE GS (GUIDE SHEATH) INSERTION, AND HEPARIN WAS ADDED AFTER THAT. THE

  Patient problems: Stroke/CVA

  MAUDE report 22012451 ↗
• InjuryApr 28, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ADDITIONAL INFORMATION RECEIVED STATED THAT PATIENT'S EF WAS REDUCED AND HAD A GLOBAL DILATATED HEART. THE GRADE OF REGURGITATION AFTER THE INDEX PROCEDURE WAS TRACE. FINAL GRADIENT AT THE END OF THE PROCEDURE WAS 2. THE PATIENT HAD FATIGUE AS THE SYMPTOM. ALSO, CLARIFICATION RECEIVED STATED THAT THE DEVICE USED WAS P10 INSTEAD OF THE ACE THAT WAS MENTIONED PREVIOUSLY.

  Patient problems: Mitral Valve Stenosis

  MAUDE report 21923006 ↗
• InjuryOct 16, 2024Activation Failure; Activation Failure

  EDWARDS RECEIVED NOTIFICATION OF A PASCAL IN MITRAL POSITION WHERE THE PATIENT WAS BROUGHT BACK TO THE HOSPITAL FOR A REPEAT TTE AND THE SECOND LATERAL ACE WITH AN SLDA (SINGLE LEAFLET DEVICE ATTACHMENT). THE INDEX PROCEDURE WITH PASCAL WAS COMPLETED SUCCESSFULLY WITH AN MR (MITRAL REGURGITATION) REDUCTION FROM SEVERE TO MODERATE. MR AFTER THE SLDA HAPPENED WAS BACK TO SEVERE. THE HOSPITAL IS PROCEEDING WITH USING MITRACLIP TO RE-INTERVENE. ADDITIONAL INFORMATION RECEIVED FROM THE CS STATED THAT ANATOMICALLY, THE LEAFLETS WERE THICKENED AND HAD BAD TISSUE INTEGRITY. THE PATIENT PREVIOUSLY HAD MULTIPLE BOUTS OF INFECTIVE ENDOCARDITIS. THE PHYSICIANS BELIEVE THAT THE CAUSE OF THIS WAS DUE TO PATIENT ANATOMY AND WAS NOT DEVICE RELATED. THEY BELIEVE THAT THE TISSUE EITHER TORE OR STRETCHED DUE TO THE PREVIOUS ENDOCARDITIS INFECTIONS. POST RE-INTERVENTION WITH THE MITRACLIP, THE REGURGITATION WAS TRACE WITH A GRADIENT OF 4. THE PATIENT CURRENTLY IS STABLE POST MITRACLIP RE-INTERVENTION BUT HAS AN EJECTION FRACTION OF 10%.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 20462059 ↗
• InjuryAug 2, 2024Activation Failure; Activation Failure

  EDWARDS RECEIVED NOTIFICATION OF A PASCAL IN MITRAL POSITION WHERE THE MR (MITRAL REGURGITATION) WAS REDUCED AFTER THE FIRST IMPLANT. THE MR WAS FURTHER REDUCED AFTER THE SECOND P10 BUT WITH A GRADIENT OF 7-8MMHG. IT WAS BAILED OUT TO TRY AN ACE AND THE TEAM GOT AN MR OF MODERATE/SEVERE WITH A GRADIENT OF 7. HENCE, THE ACE WAS DEPLOYED. THE PROCEDURE WAS COMPLICATED WITH MORE THAN SEVERE MR THAT SPANNED THE ENTIRE VALVE. PLAN WAS TO USE A PASCAL AT A2P2 MEDIAL POSITION AND REASSESS FOR THE POSSIBILITY OF A SECOND DEVICE. THE PASCAL WAS INSERTED AND WAS SUCCESSFUL IN BRINGING THE MR DOWN TO MODERATE AND NO MEDIAL JET AND A GRADIENT OF 3. BOTH THE PHYSICIANS DECIDED TO PROCEED WITH A SECOND DEVICE. DUE TO THE EXTENT OF THE DEFECT, THE DEVICE CHOSEN BY THE IC WAS ANOTHER PASCAL. AFTER MULTIPLE FAILED ATTEMPTS TO CAPTURE THE LEAFLETS, THE DEVICE WAS BAILED OUT. THE PHYSICIANS DECIDED TO PROCEED AT THIS TIME WITH AN ACE. THIS DEVICE WAS PLACED LATERAL TO THE FIRST DEVICE. THE MR WAS REDUCED TO MILD-MODERATE AS PER THE EC. THE GRADIENT WAS 7MMHG. BOTH PHYSICIANS DECIDED TO LEAVE THE DEVICE IN PLACE DESPITE THE HIGH GRADIENT AND THE INSIGNIFICANT REDUCTION IN MR. FOR BOTH DEVICES ALL MODA

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 19895520 ↗
• DeathJul 11, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  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: Heart Failure/Congestive Heart Failure; Mitral Valve Insufficiency/ Regurgitation; Mitral Valve Stenosis

  MAUDE report 19722495 ↗
• InjuryMay 6, 2024Activation Failure; Activation Failure

  EDWARDS RECEIVED NOTIFICATION OF A PASCAL IN MITRAL POSITION WHERE A P10 DEVICE WAS PLACED IN THE A2/P2 POSITION. THE CLINICAL SPECIALIST WAS MADE AWARE ON POST-OPERATIVE DAY 198 OF AN SLDA (SINGLE LEAFLET DEVICE ATTACHMENT) THAT WAS NOTED ON POST-OPERATIVE DAY 30 TTE (B)(6) 2023). THERE WERE NO DEVICE ISSUES DURING OR POST IMPLANTATION. IT WAS TOUGH TO VISUALIZE THE POSTERIOR LEAFLET (CATHETER/DEVICE SHADOWING) WHICH IS THE LEAFLET THAT HAD THE SLDA. THE GRADE OF MITRAL REGURGITATION (MR) AT BASELINE WAS SEVERE, AND POST-OP WAS MILD. BUT THE MR GRADE AFTER THE SLDA HAPPENED WAS MODERATE TO SEVERE. THE PATIENT WAS BEING TREATED WITH ANOTHER PASCAL ON (B)(6) 2024 TO STABILIZE THE SLDA.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 19248449 ↗
• InjuryFeb 22, 2024Malposition of Device; Patient Device Interaction Problem; Malposition of Device; Patient Device Interaction Problem

  EDWARDS RECEIVED NOTIFICATION OF A PASCAL IN MITRAL POSITION WHERE INITIALLY THE PATIENT HAD SEVERE MR, SO IT WAS ATTEMPTED TO IMPLANT A PASCAL DEVICE CENTRAL TO MEDIAL A2P2. INITIAL DEVICE POSITION WAS AT A2P2 CENTRAL WITH MINIMAL REDUCTION IN MR. IT WAS THEN REPOSITIONED MORE MEDIAL WITH OPTIMIZATION ATTEMPTS BUT WERE LIMITED DUE TO CHORDAL DENSITY. AFTER DISCUSSION IT WAS RECOMMENDED THAT WE ATTEMPT AN ACE DEVICE. IN AN EFFORT TO ELONGATE AND BAILOUT THE PASCAL DEVICE, A RUPTURED CHORD WAS NOTED AFTER RETRIEVING THE DEVICE BACK INTO THE ATRIUM. THE DEVICE WAS BAILED OUT SUCCESSFULLY AND AN ACE DEVICE IMPLANTED AT MEDIAL A2P2 TO ADDRESS THE CHORDAL RUPTURE. THE PATIENT HAD A SMALL VALVE AREA WHICH DID NOT ALLOW FOR A SECOND DEVICE TO ADDRESS THE REMAINING MR. DECISION WAS MADE TO GO WITH P10 TO START, JET SPANNING ACROSS A2/P2 BUT JET MORE DOMINANT ON MEDIAL ASPECT. IT WAS TRIED TO OPTIMIZE WITH P10 BUT COULD NOT GET THE MR DOWN. THE MR REMAINED ON THE MEDIAL ASPECT. MANEUVERING THE P10, TEAM BELIEVED THEY HAD TORN A CHORD WITH MOVEMENT ON MEDIAL ASPECT. THE STRATEGY CHANGED ONCE THE TORN CHORD WAS EXPECTED. THE ACE WAS DEPLOYED SLIGHTLY MEDIAL A2/P2 TO ADDRESS TORN CHORD. A 1 GR

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18760061 ↗
• InjuryJan 3, 2024Activation Failure; Activation Failure

  EDWARDS RECEIVED NOTIFICATION OF A PASCAL IN MITRAL POSITION WHERE THE INITIAL PASCAL IMPLANT DETACHED FROM THE POSTERIOR LEAFLET WHEN ATTEMPTING THE 2ND IMPLANT (ACE) LATERAL. THE ACE WAS IMPLANTED LATERAL AND MEDIAL TO STABILIZE THE PASCAL IMPLANT. THE DEVICE WAS STABLE POST 2 ACE IMPLANTS. THE PROCEDURE WAS COMPLETED, AND THE MR WENT FROM SEVERE TO MODERATE-SEVERE. THERE WAS SEVERE MR ACROSS THE COAPTATION LINE AT BASELINE WITH A GRADIENT OF 3MMHG. THE PROCEDURE WAS STARTED WITH A P10 DUE TO THE LARGE COAPTATION GAP, BUT THERE WAS STRUGGLE WITH THE ORIENTATION AND THE POSTERIOR LEAFLET GRASP. ON THE FINAL GRASP BEFORE RELEASE, TM INSISTED HE DID NOT SEE THE POSTERIOR LEAFLET INSERTED INTO APEX OF THE INNER PADDLE. THE PHYSICIAN THOUGHT THEY HAD SUFFICIENT LEAFLET INSERTION. THEY HAD A 1-1.5 GRADE REDUCTION WITH THE P10, AND WHEN GRASPING LEAFLETS WITH THE ACE, THEY NOTICED THAT THE MR GOT WORSE. THEY REALIZED THEY HAD LOST THE POSTERIOR LEAFLET ON THE P10 RESULTING IN A LOT OF MOBILITY ON THE P10. IT WAS THEN STABILIZED WITH AN ACE, LATERAL AND MEDIAL TO THE P10. THEY FELT THE MR COULD BE ELIMINATED THAT WAS PRESENT WHERE THEY LOST THE POSTERIOR LEAFLET. THE DAY OF THE PROCEDURE

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 18438640 ↗
• MalfunctionOct 24, 2023Break; Positioning Failure; Break; Positioning Failure

  EDWARDS RECEIVED NOTIFICATION OF A PASCAL IN MITRAL POSITION WHERE THE EDWARDS TEAM AND THE IC DECIDED TO BAIL OUT THE ACE DEVICE. WHEN BAILING OUT THE ACE, THE IC HAD A DIFFICULT TIME ELONGATING DEVICE ALL THE WAY AND THE PADDLE KNOB BOTTOMED OUT TO THE POINT WHERE THE PHYSICIAN COULD NOT COUNTER CLOCK/ELONGATE DEVICE ANY FURTHER. THE ACTUATION WIRE WAS NOT SEEN TO BE DETACHED ON ECHO OR FLUORO. WHEN DEVICE WAS SAFELY REMOVED FROM PATIENT, IT WAS NOTICED THAT THE ACTUATION WIRE WAS NO LONGER ATTACHED. THERE WAS NO HARM CAUSED TO THE PATIENT. ADDITIONAL INFORMATION FROM A CALL WITH THE SITE PHYSICIAN CONFIRMED THE SEQUENCE OF EVENTS AND SUGGESTED THAT THE INABILITY TO ELONGATE DEVICE MAY HAVE POTENTIALLY LED TO THE ACTUATION WIRE BREAK. THIS INFORMATION LED TO ADDITIONAL TESTING IN PRODUCT EVALUATION THAT WAS ABLE TO CONFIRM THE DEVICE MALFUNCTION OF INABILITY TO ELONGATE IMPLANT COULD LEAD TO ACTUATION WIRE BREAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17999974 ↗
• InjuryJul 7, 2023Entrapment of Device; Entrapment of Device

  EDWARDS RECEIVED NOTIFICATION OF A PASCAL IN MITRAL POSITION WHERE THE PROCEDURE WAS ABORTED FOLLOWING UNSUCCESSFUL PROCEDURAL RESULTS USING AN ACE AND THEN A P10. THE GRADIENTS WERE 9-10 MMHG AND THE MR REDUCTION WAS MINIMAL. UPON FINAL ASSESSMENT FOLLOWING REMOVAL OF THE PASCAL P10 THEIR APPEARED TO BE A NEW, SMALL FLAIL NOTED. MR WAS UNCHANGED FROM BASELINE AND THE PATIENT WAS HEMODYNAMICALLY STABLE. MD WAS NOT CONCERNED AND BELIEVED IT WAS INSIGNIFICANT. THERE WAS NO TREATMENT REQUIRED FOR THE PATIENT. NO DIFFICULTIES NAVIGATING THE DEVICE AND NO DENSE CHORDAL REGIONS. PATIENT WAS INOPERABLE AND THE IC WAS GOING TO TRY TO ENROLL HER INTO A VALVE REPLACEMENT TRIAL. AS PER MEDICAL OPINION, THE PERCEIVED ROOT CAUSE OF THE FLAIL WAS CALCIFIED, DEGENERATIVE VALVE, AND NOT DEVICE RELATED.

  Patient problems: Rupture

  MAUDE report 17281587 ↗
• MalfunctionJun 8, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  EDWARDS RECEIVED NOTIFICATION OF A PASCAL IN MITRAL POSITION WHERE THE FIRST IMPLANT ENDED UP IN FINGER DETACHMENT BEFORE CROSSING VALVE. IMPLANT WAS SUCCESSFULLY RETRIEVED. GUIDE AND P10 WERE REPLACED AND IMPLANTED SUCCESSFULLY.THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A GOOD REDUCTION IN MR FROM 4 TO 1. NO ADVERSE EVENTS WERE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17090326 ↗
• MalfunctionMar 2, 2023Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  2023-03758-02 EDWARDS RECEIVED NOTIFICATION OF A PASCAL IN MITRAL POSITION WHERE AIR BUBBLES MORE THAN NORMAL WAS NOTICED ON ECHO WHEN IMPLANT CATHETER WAS ADVANCED FOR FIRST TIME WHEN INITIAL TRAJECTORY CHECK WAS COMMENCED. THIS PHENOMENON OCCURRED WITH BOTH DEVICES IN THIS CASE- THE ACE AND THE P10. DEVICES WERE PREPPED ACCORDING TO IFU AND CONFIRMED WITH THE SME. THIS MEDWATCH IS FOR THE SECOND OF THE TWO DEVICES. MR SEVERITY AT BASELINE WAS SEVERE 4+ AND POST OP WAS NONE TO TRACE 0.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16471216 ↗
• MalfunctionMar 1, 2023Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  EDWARDS RECEIVED NOTIFICATION FOR A PASCAL IN MITRAL POSITION WHERE AIR BUBBLES WERE INTRODUCED INTO ATRIUM FROM STEERABLE CATHETER WHEN FIRST ADVANCING THE IMPLANT HANDLE. DESPITE A FIELD TRAINER DOUBLE FLUSHING THE STEERABLE CATHETER THERE WERE POTENTIAL AIR BUBBLES INTRODUCED INTO THE LA WHEN THE PHYSICIAN FIRST ADVANCED THE IMPLANT CATHETER. P10 WAS PREPPED BY THE CLINICAL TRAINER AND THE STEERABLE CATHETER WAS FLUSHED WITH 2 FULL SYRINGES OF HEPARINIZED SALINE. AIR BUBBLES WERE INTRODUCED INTO THE LA WHEN THE IMPLANT HANDLE WAS ADVANCED BY THE PHYSICIAN FOR THE FIRST TIME. DR. LATIB WAS CONCERNED, BUT THERE WAS NO HARM TO THE PATIENT AND NO ADVERSE EVENTS. THE VOLUME OF AIR EJECTED FROM THE STEERABLE CATHETER WAS GREATER THAN WHAT IS TYPICALLY SEEN DURING A PASCAL PROCEDURE. MR SEVERITY AT BASELINE WAS SEVERE 4+ AND MR SEVERITY POST OP WAS SEVERE 4+.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16464194 ↗
• MalfunctionJan 10, 2023Detachment of Device or Device Component

  PASCAL DEVICE DURING TRANSCATHETER EDGE TO EDGE MITRAL VALVE REPAIR- METAL MATERIAL FROM CATHETER DETACHED DURING SECOND DEVICE DEPLOYMENT REQUIRING SNARE RETRIEVAL. METAL MATERIAL WAS EMBOLIZED INTO INTERNAL ILIAC ARTERY. NO OBVIOUS PATIENT HARM AT THIS TIME. MITRAL VALVE REPAIR ITSELF WAS SUCCESSFUL.

  Patient problems: Foreign Body In Patient

  MAUDE report 16130450 ↗
• InjuryDec 22, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  NO NEW EVENT INFORMATION. SUPPLEMENTAL REPORT IS BEING FILED SINCE USER FACILITY'S VOLUNTARY MEDWATCH WAS RECEIVED FROM THE FDA AND TO LINK THE USER FACILITY REPORT NUMBER WITH EDWARDS (MANUFACTURER'S) MEDWATCH. USER FACILITY VOLUNTARY MEDWATCH REPORT NUMBER IS (B)(4).

  Patient problems: Foreign Body Embolism; Foreign Body In Patient; Perforation of Vessels

  MAUDE report 16040156 ↗

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