PASCALRecalls & reported problems across all models

We found 2 models of PASCAL by Edwards Lifesciences LLC in the FDA's device registry (GUDID). Together they are named in 83 adverse event reports in the FDA's MAUDE database, received between Dec 22, 2022 and Apr 15, 2026 — classified as 3 deaths, 68 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (37 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. 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 PASCAL problems

PASCAL models

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

• PASCAL 20000ISM

  Mitral Valve Repair Devices
  2 deaths67 reports
• PASCAL 20000IS

  Mitral Valve Repair Devices
  1 death16 reports

Recent PASCAL adverse event reports

The 15 most recent reports across all models, 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 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 ↗
• 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 ↗

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