PASCAL 20000ISMRecalls & reported problems

Summary

The FDA's MAUDE database contains 67 adverse event reports that list this exact device (DI 00690103216950), received between Jan 16, 2023 and Apr 15, 2026 — classified as 2 deaths, 58 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (33 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 25 most recent of 67 reports, in the reporter's own words as published by the FDA.

• InjuryApr 15, 2026Activation Failure

  ADDITIONAL INFORMATION RECEIVED FROM THE CS (CLINICAL SPECIALIST) STATED, THERE WERE NO DEVICE ISSUES INVOLVING IMPLANTATION, NO PROCEDURAL COMPLICATIONS DUE TO IMAGING, AND THE SLDA MAY HAVE BEEN DUE TO ONLY ONE DEVICE BEING DEPLOYED INSTEAD OF TWO IMPLANTS FOR STABILIZATION OF A LARGE PROLAPSE.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 24891281 ↗
• InjuryApr 9, 2026Activation Failure

  EDWARDS RECEIVED NOTIFICATION OF A PASCAL IN MITRAL PROCEDURE WHERE AN INTRA-PROCEDURE SLDA (SINGLE LEAFLET DEVICE ATTACHMENT) OCCURRED AT THE CENTRAL/LATERAL ACE IMPLANT FOLLOWING AVP (AMPLATZER VASCULAR PLUG) ATTEMPT, WHICH FAILED TO REDUCE THE MR (MITRAL REGURGITATION). ACE IMPLANT WAS SUGGESTED PRIOR. HOWEVER, THE PHYSICIAN CHOSE AVP ORIFICE MEASUREMENT. A THIRD ACE IMPLANT WAS PLACED CENTRALLY BETWEEN THE FIRST AND SECOND IMPLANTS. A FOURTH ACE IMPLANT WAS PLACED LATERALLY TO STABILIZE THE SLDA. PRE-PROCEDURE MR WAS SEVERE. MR AT THE TIME OF SLDA WAS MODERATE. THE PROCEDURE WAS COMPLETED AND MR WAS REDUCED FROM SEVERE TO MODERATE.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 24831162 ↗
• InjuryMar 24, 2026Patient Device Interaction Problem

  EDWARDS RECEIVED NOTIFICATION OF A PASCAL IN MITRAL PROCEDURE WHERE LEAFLET PERFORATION OCCURRED WHILE CAPTURING. NOTED WERE TWO FLAILED SEGMENTS AT A2/P2 MEDIAL AND LATERAL AND MAC (MITRAL ANNULAR CALCIFICATION). MR (MITRAL REGURGITATION) BEFORE LEAFLET DAMAGE WAS SEVERE. MR AFTER LEAFLET DAMAGE WAS MODERATE. PROCEDURE WAS COMPLETED AND MR REDUCED FROM SEVERE TO MODERATE/SEVERE.

  Patient problems: Cusp Tear

  MAUDE report 24681427 ↗
• InjuryMar 19, 2026Activation Failure; Patient Device Interaction Problem

  EDWARDS RECEIVED NOTIFICATION OF A PASCAL IN MITRAL POSITION PROCEDURE WHERE TWO DAYS POST INDEX PROCEDURE IT WAS DISCOVERED THAT THE PREVIOUSLY IMPLANTED PASCAL DEVICE BECAME DETACHED FROM THE POSTERIOR LEAFLET WHICH WAS ASCERTAINED BY POST-OP SURFACE TTE (TRANSTHORACIC ECHOCARDIOGRAM). SEVEN DAYS POST INDEX PROCEDURE A REINTERVENTION OCCURRED TO STABILIZE THE INDEX PROCEDURE PASCAL DEVICE. THE PROCEDURE WAS COMPLETED, TWO ADDITIONAL PASCAL DEVICES WERE IMPLANTED, AND MR (MITRAL REGURGITATION) WAS REDUCED FROM SEVERE TO MILD.

  Patient problems: Intraoperative Cardiac Valve Injury; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 24643945 ↗
• InjuryFeb 5, 2026Activation Failure

  EDWARDS RECEIVED NOTIFICATION OF A PASCAL IN MITRAL PROCEDURE WHERE THE PATIENT WAS BROUGHT BACK DUE TO WORSENING SYMPTOMS AT HOME. MR (MITRAL REGURGITATION) POST INDEX PROCEDURE WAS MILD. TTE (TRANSTHORACIC ECHOCARDIOGRAM) SHOWED MODERATE/SEVERE MR. UPON TEE (TRANSESOPHAGEAL ECHOCARDIOGRAM) ON TABLE FOR PROCEDURE, THE POSTERIOR LEAFLET WAS NOTED TO BE OUT OF THE PASCAL ACE. A SECOND PASCAL ACE WAS PLACED NEXT TO THE FIRST. THE PROCEDURE WAS COMPLETED. THE PATIENT IS STABLE. MR IS MILD.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 24269890 ↗
• InjuryJan 28, 2026Activation Failure

  EDWARDS RECEIVED NOTIFICATION OF A PASCAL IN TRICUSPID PROCEDURE WHERE THE POST PROCEDURAL TTE NOTES NOTED THE DEVICE APPEARS DETACHED FROM THE POSTERIOR LEAFLET BUT STILL ATTACHED TO THE SEPTAL LEAFLET. SCREENING TTE NOTED POTENTIAL ANATOMICAL EXCLUSIONS WERE IDENTIFIED. TR (TRICUSPID REGURGITATION) AT INDEX PROCEDURE WAS TORRENTIAL. TR AFTER INDEX PROCEDURE WAS MODERATE. TR REGURGITATION AFTER SLDA (SINGLE LEAFLET DEVICE ATTACHMENT) WAS MODERATE. (B)(4) - ADDITIONAL INFORMATION RECEIVED. FOLLOW-UP INFORMATION WAS RECEIVED FROM CORE LAB. CORE LAB REVIEWED THE DISCHARGE TTE, ECHO DATE OF (B)(6) 2025, AND CONFIRMED THE SLDA. TR GRADE WAS MASSIVE AT DISCHARGE.

  Patient problems: Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 24203367 ↗
• InjuryDec 24, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  EDWARDS RECEIVED NOTIFICATION OF A PASCAL IN MITRAL PROCEDURE WHERE CHORDAE DAMAGE WAS REPORTED. AT FIRST GRASP WITH THE SECOND ACE DEVICE, PATIENT HAD TRACE-MILD MR (MITRAL REGURGITATION) BUT GRADIENT OF 6MM. DUE TO PATIENTS AGE, PHYSICIAN WANTED TO REPOSITION AND MOVE CLOSER TO THE FIRST ACE IN AN ATTEMPT TO LOWER THE GRADIENT. AFTER RELEASING AND REPOSITIONING, PML (POSTERIOR MITRAL LEAFLET) PROVED VERY DIFFICULT TO GRASP. NOTED WAS DEGRADED TISSUE INTEGRITY AND POSSIBLE CHORD ENTANGLEMENT BUT DIFFICULT TO PINPOINT AS DEVICE WAS ALWAYS RESPONSIVE. FLUORO ALWAYS USED TO LOOK AT CATHETER INTERACTION/BOWING. THE SECOND DEVICE WAS THEN PLACED A3/P3. THERE CONTINUED TO BE WORSENING MR AND MORE EVIDENCE OF MULTIPLE MEDIAL COMMISSURAL CHORDAE FLAILS. AT THIS POINT PATIENT WAS HEMODYNAMICALLY UNSTABLE/ ON MORE EPINEPHRINE. DECISION WAS MADE TO GET CTS (CARDIOTHORACIC SURGEON) CONSULT; IABP (INTRA-AORTIC BALLOON PUMP) WAS PLACED, AND THE PATIENT WENT TO THE OR (OPERATING ROOM) FOR A MVR. MR WAS MILD BEFORE THE CHORDAE DAMAGE. AFTER THE CHORDAE DAMAGE MR WAS REPORTED AS SEVERE.

  Patient problems: Intraoperative Cardiac Valve Injury

  MAUDE report 23888579 ↗
• DeathDec 18, 2025Malposition of Device; Malposition of Device

  ON JANUARY 16, 2026, ADDITIONAL INFORMATION RECEIVED FROM CLINICAL SPECIALIST AFTER DEVICE PLACEMENT, THE MR (MITRAL REGURGITATION) WAS REDUCED TO TRIVIAL; HOWEVER, THE HEMOLYSIS DID NOT IMPROVE. GIVEN THE PATIENTS PREEXISTING FRAILTY, THEY PASSED AWAY AT THE END OF LAST YEAR. ON JANUARY 21, 2026, ADDITIONAL INFORMATION RECEIVED FROM CLINICAL SPECIALIST THE EXACT DATE OF THE PATIENT'S DEATH IS UNKNOWN. HEMOLYSIS PERSISTED DESPITE BLOOD TRANSFUSIONS AND DEVICE PLACEMENT. BASED ON THE PHYSICIAN'S COMMENTS, THE CAUSAL RELATIONSHIP WITH THE PRODUCT REMAINS UNCLEAR. AN ECCENTRIC JET ON THE MEDIAL SIDE WAS INITIALLY SUSPECTED TO BE THE CAUSE OF HEMOLYSIS. THE CONDITION DID NOT SIGNIFICANTLY IMPROVE, EVEN AFTER IMPLANTATION, LEAVING THE CAUSE UNDETERMINED. THE PATIENT HAD BEEN IN A WEAKENED STATE PRIOR TO THESE EVENTS. AFTER THE INTERVENTION PROCEDURE, THE RESIDUAL REGURGITATION WAS REDUCED TO TRIVIAL AND CONSIDERED CONTROLLED.

  Patient problems: Hemolysis; Hemolytic Anemia; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 23839359 ↗
• InjuryDec 15, 2025Activation Failure; Activation Failure

  12DEC2025 - ADDITIONAL INFORMATION RECEIVED: PLAN IS TO KEEP THE PATIENT FOR OBSERVATION AND RETRY WITH ADDITIONAL CLIP(S) ON MONDAY AM ((B)(6)). SURGEON SEEMS CAUTIOUSLY OPTIMISTIC IT WILL WORK. 18DEC2025 - ADDITIONAL INFORMATION RECEIVED: ON (B)(6) 2025 A FOLLOW-UP PROCEDURE WAS PERFORMED BY ADDING TWO ADDITIONAL PASCAL ACE CLIPS. THE SEVERE REGURGITATION IS GROSSLY UNCHANGED. THE SURGEON SUGGESTED OPTION OF AN OPEN CHEST PROCEDURE, BUT PREVIOUSLY STATED PATIENT WAS NOT A GOOD CANDIDATE. PRIOR TO THE SUGGESTION OF USING A TEER CLIP, USE OF ANOTHER DEVICE WAS DISCUSSED. PATIENT IS HOME AND DOING OK.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 23804805 ↗
• InjuryNov 3, 2025Malposition of Device; Malposition of Device

  PER REPORT RECEIVED FROM JAPAN, EDWARDS RECEIVED NOTIFICATION OF A PASCAL PRECISION ACE PROCEDURE IN MITRAL POSITION. REGARDING THE CASE ON (B)(6) 2025 IN WHICH AN ACE DEVICE WAS CENTRALLY IMPLANTED AT THE A2-P2 SEGMENT, MITRAL REGURGITATION (MR) RECURRED. DURING THE INITIAL PROCEDURE, A SMALL LESION REMAINED ON THE GRASPED LATERAL SIDE, BUT MR HAD RESOLVED AND HEMODYNAMICS HAD IMPROVED, SO THE PROCEDURE WAS CONCLUDED. HOWEVER, MR LATER RECURRED FROM THAT SAME LOCATION (GRADE 4+). THERE WAS JUST ENOUGH SPACE TO PLACE ANOTHER ACE, AND SINCE LEAFLET APPROXIMATION WAS FAVORABLE, PASCAL WAS SELECTED INSTEAD OF MITRACLIP. ALTHOUGH THE TRANSSEPTAL PUNCTURE (TSP) WAS LOW, THE PROCEDURE PROCEEDED WITH REFERENCE TO THE PREVIOUS CASE. THE FIRST DEVICE WAS SUCCESSFULLY IMPLANTED IN CLOSE PROXIMITY TO THE PRIOR ONE. A TRACE AMOUNT OF MR REMAINED BETWEEN THE DEVICES, BUT IT WAS TRIVIAL (GRADE 0+), AND THE PROCEDURE WAS COMPLETED. 27OCT2025 - ADDITIONAL INFORMATION RECEIVED FROM EW CLINICAL SPECIALIST. THE CAUSAL RELATIONSHIP BETWEEN THE REINTERVENTION AND THE DEVICE. WHILE ANATOMICAL FACTORS OF THE PATIENT WERE ALSO INVOLVED, THE DETAILS REMAIN UNCLEAR.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 23452962 ↗
• InjuryNov 3, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  PER REPORT RECEIVED FROM JAPAN, EDWARDS RECEIVED NOTIFICATION OF A PASCAL PRECISION ACE PROCEDURE IN MITRAL POSITION. A CASE IN WHICH THE DEVICE WAS IMPLANTED AT (B)(6) HOSPITAL ON (B)(6) 2024 UNDERWENT SURGICAL INTERVENTION AT (B)(6) ON (B)(6) 2025. IN THE INITIAL PROCEDURE IN 2024, A PERFORATION OCCURRED WITH MITRACLIP. THE DEVICE WAS SUBSEQUENTLY IMPLANTED AT THE SITE. THE DEVICE WAS EXPLANTED DUE TO THE MITRAL STENOSIS (MS) AND DISCARDED AT THE HOSPITAL. NO INFORMATION WAS OBTAINED REGARDING A CAUSAL RELATIONSHIP WITH THE PRODUCT OR THE PROCEDURE.

  Patient problems: Mitral Valve Stenosis

  MAUDE report 23452544 ↗
• InjuryOct 2, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  EDWARDS RECEIVED NOTIFICATION OF A PASCAL IN MITRAL PROCEDURE WHERE LEAFLET DAMAGE OCCURRED INTRA-PROCEDURE. VALVE WAS EXTREMELY DIFFICULT WITH MULTIPLE JETS, EXTREME CALCIUM, VERY THIN PLIABLE LEAFLETS, AND A CLEFT BETWEEN P2/P3. THE FIRST DEVICE WAS DEPLOYED SUCCESSFULLY. THE SECOND DEVICE WAS GRASPED 3-5 TIMES NEAR THE CLEFT. PHYSICIAN MOVED LATERAL AND GRASPED LEAFLET. A FLAIL WAS MADE ON THE POSTERIOR LEAFLET DUE TO MULTIPLE GRASPING ATTEMPTS ON POOR LEAFLET INTEGRITY TOO THIN TO BE VISUALIZED. A FLAIL WAS LEFT BETWEEN THE TWO DEVICES THAT WAS UNABLE TO BE GRASPED DUE TO LEAFLETS BEING TOO THIN TO BE VISUALIZED. PROCEDURE WAS COMPLETED. THE MR (MITRAL REGURGITATION) WAS NOT REDUCED.

  Patient problems: Cusp Tear

  MAUDE report 23199438 ↗
• InjuryJul 31, 2025Activation Failure; Activation Failure

  EDWARDS RECEIVED NOTIFICATION OF A PASCAL IN MITRAL PROCEDURE WHERE A SLDA (SINGLE LEAFLET DEVICE ATTACHMENT) OCCURRED ON THE SECOND DEVICE. A LARGE P2 PROLAPSE WITH STRONG POSTERIOR CHORDS CREATING A PARACHUTING OF PROLAPSED TISSUE WERE NOTED. IMPLANTER GRASPED THE POSTERIOR LEAFLET, LOTS OF TISSUE WAS CAPTURED ON THE PADDLE, LIKELY INCLUDING STRONG POSTERIOR CHORD WITHIN GRASP. POSTERIOR CLASP DROP WAS SUCCESSFUL. ANTERIOR LEAFLET WAS CAPTURED SUCCESSFULLY. WITH DEVICE CLOSURE LEAFLETS BOTH PULLED IN, ONCE POSTERIOR SUTURE WAS REMOVED, POSTERIOR LEAFLET SLIPPED ABOVE THE CLASP WHICH WAS VERIFIED BY OPENING IMPLANT AND VISUALIZING POSTERIOR CLASP BOUNCING. ANTERIOR CLASP WAS STILL FUNCTIONAL. ECHO INTERROGATION REVEALED LONG POSTERIOR LEAFLET MOVING THROUGH CENTER OF DEVICE, DIFFICULT TO SEE, YET LIKELY CHORD CAPTURED IN CLASP. ANTERIOR CLASP WAS RAISED. CS (CLINICAL SPECIALIST) SUGGESTED MULTIPLE BAILOUT MANEUVERS. MD (MEDICAL DOCTOR) ATTEMPTED SOME MOVEMENTS OF THE IMPLANT TO FREE THE POSTERIOR LEAFLET FROM CLASP YET DID NOT WANT TO TRY ADVANCED MANEUVERS. INSTEAD, MD DECIDED TO CLOSE IMPLANT AND RELEASE. WITH RELEASE, THE IMPLANT INITIALLY STAYED ATTACHED TO THE POSTERIOR LEAFL

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 22677564 ↗
• InjuryJul 25, 2025Activation Failure; Activation Failure

  EDWARDS RECEIVED NOTIFICATION OF A PASCAL IN MITRAL PROCEDURE WHERE AFTER RELEASE OF THE FIRST IMPLANT AND INTRODUCTION/STEERING DOWN TO THE VALVE OF THE SECOND IMPLANT A SLDA (SINGLE LEAFLET DEVICE ATTACHMENT) CONFIRMED VIA TEE OCCURRED INTRA-PROCEDURALLY. THE FIRST IMPLANT REMAINED ATTACHED TO THE ANTERIOR LEAFLET AND DETACHED FROM THE POSTERIOR LEAFLET. THE PHYSICIAN OPTED TO MOVE FORWARD WITH A MULTI-DEVICE STRATEGY WITH THE SECOND IMPLANT POSITIONED LATERALLY AND PARALLEL TO THE FIRST IMPLANT IN A 1:7 ATTACHED TO A2 ORIENTATION. AFTER THE RELEASE OF THE SECOND IMPLANT LATERAL TO THE FIRST IMPLANT, THE IMPLANTER FELT IT WAS NECESSARY TO PLACE A THIRD UNPLANNED DEVICE MEDIAL TO THE FIRST/SLDA DEVICE IN A 12:6 ORIENTATION AS IT WAS HEMODYNAMICALLY FAVORABLE. THE LA V WAVE HAD INCREASED TO 35 AFTER THE FIRST IMPLANT SLDA OCCURRED AND THE LAST/THIRD IMPLANT BROUGHT IT DOWN TO 29. MR (MITRAL REGURGITATION) AT THE TIME OF SLDA WAS SEVERE. THE INDEX PROCEDURE WAS COMPLETED. THE MR WAS NOT REDUCED AND REMAINED SEVERE. IMPLANTER NOTED FLANKING A NEW IMPLANT ON EITHER SIDE OF THE FIRST/SLDA IMPLANT COULD "CREATE A SCAFFOLD" FOR POTENTIAL/FUTURE TREATMENT USING A VASCULAR PLUG.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 22613824 ↗
• DeathJul 23, 2025Difficult to Insert; Difficult to Insert

  EDWARDS RECEIVED NOTIFICATION OF A PASCAL IN MITRAL PROCEDURE WHERE AN IMPLANT WAS ATTEMPTED AND ABORTED. A PATIENT INJURY (DEATH) OCCURRED RELATED TO THE DEVICE AND PROCEDURAL COMPLICATION. TSP (TRANSSEPTAL PUNCTURE) WAS ATTEMPTED 3 TIMES. THE WIRE VERY EASILY SLIPPED ACROSS THE IAS (INTERATRIAL SEPTUM). TSP WAS REATTEMPTED DUE TO HEIGHT OF THE FIRST TSP. CLINICAL SPECIALIST MENTIONED THAT THE WIRE SLIPPED ACROSS THE IAS LIKE BUTTER YET THEY DID NOT BELIEVE A PERFORATION WAS CREATED DURING THAT PROCEDURAL STEP AS NO EFFUSION WAS SEEN AT THAT TIME. 1 ACE WAS PLACED MEDIAL A2P2. THE SECOND DEVICE WAS INSERTED, AND UPON EXITING THE GUIDE AND CLOSING, IT WAS NOTED ON FLUORO THAT THE IMPLANT APPEARED TO HAVE TENSION. IC WAS EXITING GS (GUIDE SHEATH) AND CLOSING IMPLANT WITHOUT ECHO GUIDANCE AND WAS LOOKING ONLY ON FLUORO. WHILE ON FLUORO, IC CLOSED THE DEVICE AND STARTED TO FLEX DOWN, AND WHEN ECHO WAS VISUALIZED AGAIN, EC (ECHOCARDIOGRAPHER) INFORMED TEAM THAT THE IMPLANT WAS OUTSIDE OF THE PERICARDIUM AND CARDIAC TAMPONADE WAS NOTED. THE TEAM BEGAN CPR, AND IC PROCEEDED TO PERFORM A PERICARDIAL TAP WITH COPIOUS AMOUNTS OF VERY THIN BLOOD. SURGICAL TEAM TOOK OVER AT WHICH POINT THE DE

  Patient problems: Cardiac Perforation

  MAUDE report 22576793 ↗
• InjuryJul 21, 2025Activation Failure; Activation Failure

  EDWARDS RECEIVED NOTIFICATION OF A PASCAL IN MITRAL PROCEDURE WHERE A SLDA (SINGLE LEAFLET DEVICE ATTACHMENT) OCCURRED. TWO ADDITIONAL ACE DEVICES WERE PLACED. A THIRD ACE WAS ATTEMPTED MEDIAL TO THE MIDDLE DEVICE. THE POSTERIOR LEAFLET KEPT SLIPPING OUT OF THE DEVICE. THE DEVICE WAS ELONGATED AND CAME BACK TO LA TO RESET. IT WAS NOTED THE POSTERIOR LEAFLET SLIPPED OUT OF THE A2P2 ACE. THE PHYSICIAN WAS UNABLE TO PLACE THE DEVICE RIGHT NEXT TO THIS ONE DUE TO LACK OF POSTERIOR LEAFLET. THE PERCEIVED ROOT CAUSE IS LACK OF LEAFLET INTEGRITY, HEART BEING EXTREMELY HYPER DYNAMIC DURING PROCEDURE, AND PATIENT ON PRESSORS AND IABP. THE THIRD DEVICE WAS PLACED AT A3P3 AND THE ANNULUS WAS STABLE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THE MR WAS REDUCED FROM SEVERE TO MODERATE/SEVERE. GRADE OF MR AT TIME OF SLDA WAS MODERATE-SEVERE TO SEVERE.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 22555238 ↗
• InjuryJul 10, 2025Activation Failure; Activation Failure

  EDWARDS RECEIVED NOTIFICATION OF A PASCAL IN TRICUSPID PROCEDURE WHERE DURING OPTIMIZATION OF THE THIRD IMPLANT, THE DEVICE BECAME ENTANGLED WITH THE SECOND IMPLANT. IN ATTEMPTING TO FREE FROM THE IMPLANTED DEVICE, THE SECOND IMPLANT BECAME DETACHED FROM THE SEPTAL LEAFLET RESULTING IN AN SLDA (SINGLE LEAFLET DEVICE ATTACHMENT). THE THIRD IMPLANT WAS ULTIMATELY FREED FROM THE SECOND WITHOUT FURTHER ISSUE. AT THIS TIME, THE THIRD ACE WAS REMOVED, AND ANOTHER WAS PREPPED TO ATTEMPT AN IMPLANT NEXT TO THE SECOND TO STABILIZE AND REDUCE TR SEVERITY. A THIRD DEVICE WAS SUCCESSFULLY PLACED AS INTENDED, HOWEVER DUE TO TR SEVERITY STILL MEASURED AT SEVERE. THE THIRD IMPLANT WAS ABORTED TO WORK PATIENT UP FOR POSSIBLE EVOQUE. THE PATIENT FINAL OUTCOME WAS STABLE.

  Patient problems: Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 22470783 ↗
• MalfunctionJun 10, 2025Air/Gas in Device; Air/Gas in Device

  EDWARDS RECEIVED NOTIFICATION OF A PASCAL IN MITRAL POSITION WHERE PER INTERNAL IMAGING REVIEW OF INTRAPROCEDURAL TEE, THERE APPEARED 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 IMPLANT CATHETER. IN SUBSEQUENT IMAGING, AIR IS NO LONGER OBSERVED. THERE WERE NO RECORDED EKG CHANGES DURING ANY OF THE TIME POINTS, OR CHANGES IN HEART RATE/RHYTHM. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A REDUCTION IN MR FROM SEVERE TO MILD.

  Patient problems: Air Embolism

  MAUDE report 22178273 ↗
• MalfunctionJun 10, 2025Air/Gas in Device; Air/Gas in Device

  EDWARDS RECEIVED NOTIFICATION OF A PASCAL IN MITRAL POSITION WHERE PER INTERNAL IMAGING REVIEW OF INTRAPROCEDURAL TEE, THERE APPEARED 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 IMPLANT CATHETER. IN SUBSEQUENT IMAGING, AIR IS NO LONGER OBSERVED. THERE WERE NO RECORDED EKG CHANGES DURING ANY OF THE TIME POINTS, OR CHANGES IN HEART RATE/RHYTHM. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A REDUCTION IN MR FROM SEVERE TO MILD.

  Patient problems: Air Embolism

  MAUDE report 22178226 ↗
• InjuryMay 23, 2025Activation Failure; Patient Device Interaction Problem; Activation Failure; Patient Device Interaction Problem

  EDWARDS RECEIVED NOTIFICATION OF A PASCAL IN MITRAL POSITION WHERE THE PHYSICIAN INFORMED THE CLINICAL SPECIALIST THAT THERE WAS AN SLDA (SINGLE LEAFLET DEVICE ATTACHMENT) THAT OCCURRED. BASELINE MR (MITRAL REGURGITATION) PRIOR TO INDEX PROCEDURE WAS SEVERE AND POST PROCEDURE WAS MILD, BUT AFTER THE SLDA HAPPENED IS UNKNOWN. THE PATIENT IS STABLE AND THE PLAN IS TO STABILIZE THE VALVE WITH ANOTHER IMPLANT.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 22079867 ↗
• InjuryMay 20, 2025Difficult to Insert; Difficult to Insert

  EDWARDS RECEIVED NOTIFICATION OF A PASCAL IN MITRAL POSITION WHERE THE IMPLANT WAS ATTEMPTED AND THEN ABORTED BECAUSE PERICARDIAL EFFUSION WAS NOTED AFTER THE DEVICE WAS IN THE LA (LEFT ATRIUM). THE DEVICE WAS THEN BAILED OUT, SYSTEM REMOVED, AND THE PATIENT WAS TAKEN TO CVOR. THE OVERALL PROCEDURE WAS ABORTED WITH THE MR SAME AS BASELINE MODERATE/SEVERE. THE PATIENT DID NOT HAVE ANY SYMPTOMS. THE EFFUSION DID LEAD TO CARDIAC TAMPONADE. THE PERFORATION WAS BELIEVED TO BE IN THE LA, BUT IT IS UNABLE TO BE CONFIRMED. PERICARDIAL EFFUSION WAS LARGE AND AFFECTED MOSTLY THE RIGHT VENTRICLE. THE PATIENT HAD A PERICARDIOCENTESIS PERFORMED ON THE TABLE IN THE CATH LAB AND WAS PLACED ON ECMO TO BE TRANSFERRED TO OPEN HEART SURGERY.

  Patient problems: Cardiac Perforation

  MAUDE report 22055524 ↗
• InjuryMay 8, 2025Activation Failure; Activation Failure

  EDWARDS RECEIVED NOTIFICATION OF A PASCAL IN MITRAL POSITION WHERE THE PATIENT HAD A LATE SLDA (SINGLE LEAFLET DEVICE ATTACHMENT). PHYSICIAN STATED THAT SLDA OCCURRED DUE TO EXTENSIVE LEAFLET MOBILITY DUE TO BARLOW'S ANATOMY. THE PHYSICIAN QUESTIONED WHETHER ONE ROW OF RETENTION ELEMENTS IS ENOUGH FOR PATIENTS WITH THIS ANATOMICAL DEFECT. THE STARTING MR WAS SEVERE/TORRENTIAL AND ENDING MR WAS MILD, BUT THE MR AFTER THE SLDA HAPPENED WAS BACK TO SEVERE. THE PATIENT HAD A HEART FAILURE HOSPITALIZATION AS A RESULT OF THE SLDA EVENT BUT IS NOW DISCHARGED AND STABLE. CURRENTLY THERE ARE DISCUSSIONS ON REINTERVENTION FOR THE PATIENT, BUT THE PATIENT IS VERY FRAIL. CURRENTLY MANAGED ON MEDS, MAY CONSIDER ADDITIONAL TEER REINTERVENTION IN THE FUTURE.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 21986433 ↗
• InjuryApr 29, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  EDWARDS RECEIVED A REPORT OF A PASCAL PROCEDURE IN TRICUSPID POSITION WHERE THERE WAS WORSENING TR. 30 DAY TTE DONE ON POD 44 SHOWS TR AS MODERATE, AND 6 MONTH TTE DONE ON POD 177 SEVERE TR LIKELY DUE TO A LEAFLET PERFORATION SUSPECTED AROUND THE 30 DAY TIMEPOINT.

  Patient problems: Cusp Tear; Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 21926403 ↗
• InjuryApr 29, 2025Activation Failure; Activation Failure

  EDWARDS RECEIVED A REPORT OF A PASCAL PROCEDURE IN MITRAL POSITION WHERE WHEN IMPLANTING A 3RD PASCAL, THE IMPLANT RELEASE WAS DIFFICULT WHEN DETACHING FROM THE ATTACHMENT FINGERS. ALL TROUBLESHOOTING TECHNIQUES SPECIFIED IN THE PROCEDURAL MANUAL WERE ATTEMPTED WITHOUT SUCCESS. THE PHYSICIAN THEN GAVE THE IMPLANT SYSTEM AN ABRUPT, QUICK, AND FIRM YANK WHILE MOUNTED IN THE SRS AT WHICH POINT THE IMPLANT RELEASED. THE TUG ON THE DEVICE RESULTED IN POSTERIOR LEAFLET BEING PULLED OUT OF THE DEVICE'S GRASP. IT WAS NOTED THE 3RD IMPLANT WAS STABLE AND NOT MOBILIZED, ONLY ROCKING WITH THE CARDIAC MOTION. THE PATIENT'S MR WAS REDUCED FROM SEVERE TO MODERATE/SEVERE ONLY AFTER IMPLANTATION OF THE 3RD DEVICE. DEVICE WAS STABLE AND PATIENT WAS DISCHARGED WITHOUT FURTHER INCIDENT THE FOLLOWING MORNING. THERE WERE NOTED ANATOMICAL CHALLENGES. THE ATRIUM WAS NOTED TO BE A HUGE ATRIUM MEASURING 9X9 MM WITH A TSP HEIGHT OF 5X5 MM RESULTING IN VERY DIFFICULT IMAGING DURING THE CASE. THERE WAS NO DEVICE ISSUE PERCEIVED FROM THE SITE, BUT THE CS MENTIONED THE OTHER COLLEAGUE DETERMINED THE REASON FOR DIFFICULTY REMOVING THE DEVICE WAS THAT THEY LOST TOO MUCH HEIGHT TO REACH TARGET LOCATION, RESULTING

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 21926352 ↗
• InjuryApr 16, 2025Activation Failure; Activation Failure

  EDWARDS RECEIVED NOTIFICATION OF A PASCAL IN MITRAL POSITION WHERE THERE WAS AN SLDA (SINGLE LEAFLET DEVICE ATTACHMENT). THE TEAM HAD EXPRESSED CONCERNS WITH THE POSTERIOR GRASP, BUT THE PHYSICIAN WAS CONFIDENT WITH THE GRASP. THE TEAM OPTIMIZED MULTIPLE TIMES. THE DEVICE WAS STABLE POST RELEASE, BUT 15 MINUTES LATER (AFTER THE GUIDE WAS ALREADY REMOVED), THE POSTERIOR LEAFLET CAME OUT. THE TEAM WENT BACK IN AND STABILIZED THE DEVICE WITH ANOTHER ACE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A REDUCTION IN MR (MITRAL REGURGITATION) FROM SEVERE TO NONE/TRACE. WHEN THE SLDA HAPPENED, THE MR WAS SEVERE. THE PATIENT IS IN STABLE CONDITION.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 21849632 ↗

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