PERCEVAL PLUSRecalls & reported problems across all models

We found 4 models of PERCEVAL PLUS by Corcym Canada Corp in the FDA's device registry (GUDID). Together they are named in 149 adverse event reports in the FDA's MAUDE database, received between Nov 16, 2020 and Sep 27, 2026 — classified as 3 deaths, 136 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (44 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 PERCEVAL PLUS problems

PERCEVAL PLUS models

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

• PERCEVAL PLUS PVF-M

  heart-valve, non-allograft tissue
  1 death47 reports
• PERCEVAL PLUS PVF-S

  heart-valve, non-allograft tissue
  36 reports
• PERCEVAL PLUS PVF-L

  heart-valve, non-allograft tissue
  2 deaths35 reports
• PERCEVAL PLUS PVF-XL

  heart-valve, non-allograft tissue
  31 reports

Recent PERCEVAL PLUS adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 27, 2026Inadequacy of Device Shape and/or Size

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 50909497 ↗
• InjuryJul 30, 2026Leak/Splash

  The manufacturer was notified of an intraoperative explant involving a Perceval Plus valve. Based on the information received, on (b)(6) 2026, the patient underwent AVR + CABG. During sizing, the medium (M) white sizer passed through the annulus with slight resistance, while the large (L) white sizer could not pass through the annulus. Therefore, a Perceval Plus size M valve was selected. Patient¿s annulus size was 25mm. After aortic cross-clamp removal, intraoperative TEE revealed severe paravalvular leakage (PVL) near the left-noncoronary (LN) commissure. Consequently, the Perceval Plus M valve was explanted and was replaced with a 19-mm Magna valve. The operation was then completed successfully. Approximately, 40 minutes was added to the procedure as a result of this complication. The patient remained stable throughout the delay in procedure.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 50085939 ↗
• InjuryJul 30, 2026Degraded

  The manufacturer was notified of an explant (redo surgery) involving a Perceval Plus valve. Based on the information received, the Perceval Plus valve size S was implanted via MICS-AVR on (b)(6)2025. Symptoms of AS/R (aortic stenosis/regurgitation) were observed starting around three or four months ago. By June, the AS had progressed, and as one valve leaflet was immobile, a reoperation was performed on (b)(6)2026. It was determined that the leaflet corresponding to the right coronary cusp was immobile because it was folded outward and had become rigid due to degeneration. As the area near the immobile valve leaflets had become difficult to excise due to pannus proliferation and other factors, the stent in that region was cut, and the Perceval Plus was removed. After explanting the Perceval Plus, the Inspiris 19 was implanted, and the surgery was concluded. The patient presents no factors, such as dialysis, that would cause degeneration of the valve leaflets. There was no reported adverse event or outcome for the patient.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 50085798 ↗
• InjuryMay 12, 2026Insufficient Device Problem Information

  THE MANUFACTURER WAS NOTIFIED OF AN INTRAOPERATIVE EXPLANT INVOLVING A PERCEVAL PLUS VALVE. BASED ON THE INFORMATION RECEIVED, A PERCEVAL PLUS PVF-S VALVE WAS IMPLANTED IN A PATIENT ON (B)(6) 2026 DURING A SINGLE-LEAFLET AVR PROCEDURE PERFORMED VIA THE TAX APPROACH. ALTHOUGH NO ABNORMALITIES WERE OBSERVED ON THE TEE FOLLOWING IMPLANTATION, BLEEDING WAS CONFIRMED AT THE AORTIC ROOT DURING CLOSURE. THIS WAS JUDGED TO BE AN ANNULAR RUPTURE, SO THE PROCEDURE WAS CONVERTED TO A MEDIAN INCISION; THE PRODUCT WAS REMOVED, THE DAMAGED SITE WAS REPAIRED WITH BOVINE PERICARDIUM, AND AN INSPIRIS DEVICE WAS IMPLANTED DUE TO CONCERNS ABOUT RE-RUPTURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Rupture

  MAUDE report 25151028 ↗
• InjuryFeb 5, 2026Inadequacy of Device Shape and/or Size

  THE MANUFACTURER WAS NOTIFIED OF A PARAVALVULAR LEAK INVOLVING A PERCEVAL PLUS PROSTHESIS. THE FOLLOWING PROVIDES A SUMMARY OF ALL INFORMATION CURRENTLY AVAILABLE TO THE MANUFACTURER. A PERCEVAL PLUS VALVE PVF-S WAS IMPLANTED ON (B)(6) 2025 DURING AN AVR SURGERY WITH NO CONCOMITANT PROCEDURES. NO POSITIONING PROBLEMS WERE ENCOUNTERED DURING THE IMPLANTATION PROCEDURE. THE PATIENT DID NOT PRESENT ANY ABNORMAL GEOMETRY OF THE NATIVE AORTIC VALVE. PARAVALVULAR LEAK WAS CONFIRMED ON (B)(6) 2025, AND SURGERY WAS PERFORMED AGAIN. THE PERCEVAL PLUS IN SIZE S WAS REPLACED WIH A PERCEVAL PLUS IN SIZE M. THE PATIENT HAD AN UNEVENTFUL POSTOPERATIVE COURSE AND GOOD OUTCOME.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 24266846 ↗
• InjuryFeb 4, 2026Incomplete Coaptation

  THE MANUFACTURER WAS NOTIFIED OF AN EXPLANT INVOLVING A PERCEVAL PLUS PROSTHESIS. BASED ON THE INFORMATION RECEIVED, ON (B)(6) 2025, PERCEVAL PLUS SIZE S WAS IMPLANTED. CENTRAL LEAK (MILD-MODERATE) DEVELOPED AFTER AORTIC CROSS-CLAMP REMOVAL; OBSERVATION WAS INITIATED AND THE PROCEDURE CONCLUDED. ON (B)(6) 2025, REOPERATION WAS PERFORMED TO REPLACE THE PERCEVAL WITH ANOTHER MANUFACTURER'S ARTIFICIAL HEART VALVE. FURTHER INFORMATION INDICATED THAT THE RIGHT CORONARY CUSP PORTION OF THE PERCEVAL VALVE WAS SHORTER IN HEIGHT (AND SMALLER IN AREA) COMPARED WITH THE OTHER TWO CUSPS, LIKELY RESULTING IN TETHERING. IMMEDIATELY AFTER REMOVAL OF THE AORTIC CROSS CLAMP FOLLOWING PERCEVAL IMPLANTATION, THE RIGHT CORONARY CUSP SHOWED ALMOST NO MOVEMENT, AND THE CENTRAL LEAK WAS ALSO OBSERVED ORIGINATING FROM THE RIGHT CORONARY CUSP REGION. DURING PERCEVAL SIZING, THE WHITE SIZER DID NOT PASS THROUGH THE ANNULUS, WHILE THE WHITE HEAD OF THE SIZER (SIZER S) PASSED THROUGH EASILY. IN THE PERCEVAL OPERATION ON (B)(6), THE PATIENT¿S CARDIAC FUNCTION WAS POOR AFTER AORTIC CROSS CLAMP REMOVAL, REQUIRING ECMO AND IABP INSERTION BEFORE CLOSING THE OPERATION (ECMO AND IABP ARE STILL ONGOING). AS OF (B)(6)

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 24259126 ↗
• InjuryJan 21, 2026Perivalvular Leak

  THE MANUFACTURER WAS NOTIFIED OF THE INTRAOPERATIVE EXPLANT OF A PERCEVAL PLUS AORTIC HEART VALVE IN SIZE M. THE FOLLOWING PROVIDES A COMPREHENSIVE SUMMARY OF ALL INFORMATION CURRENTLY AVAILABLE TO THE MANUFACTURER. THE PROSTHESIS WAS IMPLANTED THOUGH A MEDIAN STERNOTOMY IN A TYPE 0 BICUSPID AORTIC VALVE WITH A CIRCULAR ANATOMY, WHITHOUT CONCOMITANT PROCEDURES. NO COLLAPSING, RELEASING, MALPOSITIONING NOR SIZING ISSUES WERE REPORTED. AFTER AORTIC CROSS-CLAMPING, A PARAVALVULAR LEAK (NEAR THE RCC) WAS DETECTED. FOLLOWING RE-OCCLUSION, STENT INFOLDING WAS CONFIRMED. THE PERCEVAL VALVE WAS THEN EXPLANTED, THE ANNULUS WAS FURTHER DECALCIFIED, AND THE SAME PERCEVAL VALVE WAS RE-IMPLANTED AND HIGH-PRESSURE BALLOONING (4.5 ATM) WAS PERFORMED, BEFORE CLOSING THE AORTA. HOWEVER, ANOTHER PARAVALVULAR LEAK OCCURRED AFTER AORTIC OCCLUSION IN THE SAME RCC REGION. AFTER A SECOND RE-OCCLUSION, THE VALVE WAS EXPLANTED AGAIN AND REPLACED WITH AN ABBOT EPIC ULTRA 21MM. GIVEN THE BICUSPID ANATOMY OF THE PATIENT¿S NATIVE AORTIC VALVE, THE SURGEON NOTED THAT THE POSSIBILITY OF THE INFOLDING CAUSED BY A FIBROUS RAPHE COULD NOT BE RULED OUT.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 24127839 ↗
• InjuryDec 24, 2025Leak/Splash; Leak/Splash

  THE MANUFACTURER WAS NOTIFIED OF A FAILURE TO IMPLANT INVOLVING A PERCEVAL PLUS PROSTHESIS. REPORTEDLY, IN A REDO CASE FOLLOWING TAVI, PERCEVAL PLUS VALVE PVF-XL WAS USED ON (B)(6) 2025. HOWEVER, FOLLOWING BYPASS REMOVAL, PVL OCCURRED, NECESSITATING CONVERSION TO A CONVENTIONAL VALVE INSTEAD. BASED ON THE FURTHER INFORMATION RECEIVED, THE SURGICAL APPROACH WAS A FULL STERNOTOMY WITH NO CONCOMITANT PROCEDURE. THE NATIVE VALVE WAS STENOTIC. BALLOONING WAS PERFORMED ACCORDING TO THE IFU. APPROXIMATELY 30 MINUTES WAS ADDED TO THE CROSS-CLAMP TIME AND BYPASS TIME. THE PATIENT REMAINED STABLE THROUGHOUT THE DELAY IN PROCEDURE. THE PATIENT¿S IMPACT AND OUTCOME WERE REPORTED AS IMPROVING AND PROGRESSING WELL. THERE WERE NO REPORTED ABNORMAL GEOMETRIES IN THE PATIENT'S ANNULUS, NO DEVICE MALPOSITIONING OR MISSIZING IDENTIFIED. NO POSITIONING DIFFICULTY WAS NOTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 23889316 ↗
• InjuryDec 24, 2025Incomplete Coaptation; Incomplete Coaptation

  THE MANUFACTURER WAS NOTIFIED OF THE INTRAOPERATIVE EXPLANT A PERCEVAL PLUS PVF-L PROSTHESIS. THE FOLLOWING PROVIDES A COMPREHENSIVE SUMMARY OF ALL INFORMATION CURRENTLY AVAILABLE TO THE MANUFACTURER. THE PROCEDURE WAS PERFORMED THROUGH A FULL STERNOTOMY WITHOUT ANY CONCOMITANT INTERVENTIONS ON (B)(6) 2025. AFTER SIZING, A SIZE L VALVE WAS SELECTED FOR IMPLANTATION; HOWEVER, THERE WAS CONCERN THAT ONE LEAFLET MIGHT NOT BE FUNCTIONING PROPERLY, AND A CENTRAL LEAK WAS DETECTED ON THE ECHO PERFORMED PRIOR TO WEANING FROM CARDIOPULMONARY BYPASS. THE PERCEVAL VALVE WAS THEREFORE EXPLANTED INTRAOPERATIVELY AND REPLACED WITH A 25-MM INSPIRIS VALVE. THE PATIENT REMAINED STABLE THROUGHOUT THE DELAY IN SURGERY. NO ISSUES RELATED TO POSITIONING OR SIZING WERE NOTED. THE PATIENT'S NATIVE AORTIC VALVE WAS TRICUSPID WITH NO ABNORMAL ANNULUS GEOMETRIES.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 23886852 ↗
• InjuryNov 3, 2025Perivalvular Leak; Perivalvular Leak

  ON (B)(6) 2025, A PERCEVAL PLUS VALVE, PVF-M, WAS IMPLANTED WITH MICS PROCEDURE. AFTER DE-CLAMPED, PVL (MILD) WAS NOTED, AND THE VALVE POSITION WAS SLIGHTLY ADJUSTED. HOWEVER, SINCE MODERATE PVL WAS NOTED AGAIN AFTER DE-CLAMPED, THE VALVE WAS EXPLANTED. THE ANNULUS WAS RE-SIZED, BUT SIZE L COULD NOT GO THROUGH. AS SUCH, THE SAME VALVE WAS RE-IMPLANTED. MILD PVL WAS NOTED AFTER DE-CLAMPED, AND THE SURGERY WAS COMPLETED. THE CONDITION WAS BETTER IN THE NEXT MORNING THOUGH PVL WAS STILL NOTED. AS FURTHER REPORTED, NO POSITIONING DIFFICULTY WAS NOTED, AND BALLOONING WAS PERFORMED ACCORDING TO THE IFU. MORE THAN 60 MINUTES WAS ADDED TO THE CROSS-CLAMP TIME AND BYPASS TIME. THE PATIENT REMAINED STABLE THROUGHOUT THE DELAY IN PROCEDURE AND PATIENT¿S OUTCOME WAS GOOD. BASED ON THE MEDICAL JUDGMENT, THE SIZE SELECTION SHOULD HAVE BEEN CORRECT (M WHITE PASSED WITH SLIGHT RESISTANCE, L WHITE FAILED TO PASS), AND THE PLACEMENT POSITION SHOULD ALSO BE FINE. REPORTEDLY, THE ANNULAR SHAPE WAS DISTORTED WITH A SIGNIFICANT DIFFERENCE BETWEEN THE MAJOR AND MINOR DIAMETERS.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 23446055 ↗
• InjurySep 13, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ON (B)(6) 2025, A RE-AVR IN A PATIENT WHO HAD AN SJM 27 MM IMPLANTED IN 1989 WAS PERFORMED. AFTER SJM VALVE WAS EXPLANTED, SIZING WAS PERFORMED AS FOLLOWS: WITH SIZE XL, WHITE HEAD OF THE SIZER PASSED THROUGH WITH SLIGHT RESISTANCE. AS SUCH, PERCEVAL PLUS SIZE XL WAS SELECTED AND IMPLANTED IN THE PATIENT. ECHOCARDIOGRAPHIC EVALUATION AFTER OCCLUSION RELEASE, REVEALED A SLIGHT GAP ON THE N SIDE OF THE VALVE AND PVL AT LCC. AFTER RE-OCCLUSION, THE AREA WAS EXAMINED UNDER DIRECT VISUALIZATION AND WAS REPAIRED. THIS WAS FOLLOWED BY AORTIC CLOSURE AFTER RE-BALLOONING. BASED ON THE POST-OCCLUSION ECHOCARDIOGRAM, SINCE NO DISAPPEARANCE OR IMPROVEMENT OF THE PVL WAS OBSERVED, THE PERCEVAL PLUS WAS EXPLANTED, AND EPIC VALVE SIZE 27 WAS IMPLANTED INSTEAD. IN THE POSTOPERATIVE COMMENTS, IT WAS NOTED THAT SINCE THE VALVE WAS UNDERSIZED, FURTHER REPAIRS OR ADJUSTMENTS WERE DEEMED FUTILE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 23047538 ↗
• InjurySep 2, 2025Perivalvular Leak; Malposition of Device; Perivalvular Leak; Malposition of Device

  ON (B)(6) 2025, THE PERCEVAL PLUS VALVE PVF-L WAS IMPLANTED AND PVL WAS NOTED AFTER DE-CLAMPED. SINCE IT WAS NOTICED THAT THE PART OF THE VALVE WAS PLACED AT A LITTLE LOWER POSITION, THEY TRIED TO ADJUST THE POSITION OF THE VALVE, BUT PVL WAS STILL THERE. AS SUCH, THE VALVE WAS EXPLANTED AND EPIC 25MM WAS IMPLANTED INSTEAD. NO FURTHER INFORMATION HAS BEEN RECEIVED FROM THE SITE AT THIS TIME.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 22929840 ↗
• InjuryAug 27, 2025Perivalvular Leak; Perivalvular Leak

  ON (B)(6) 2025, AFTER CONCOMITANT PROCEDURE (TAP, MAZE AND MAP), THE PERCEVAL PLUS VALVE PVF-L WAS IMPLANTED IN A PATIENT THROUGH AVR. AFTER DE-CLAMPED, A MILD PVL WAS NOTED. THEY WAITED TO SEE THE CONDITION FOR 30 MINUTES, BUT PVL REMAINED THE SAME. AS SUCH, THE VALVE WAS EXPLANTED AND REPLACED WITH INSPIRIS VALVE 25MM INSTEAD. NO FURTHER INFORMATION HAS BEEN RECEIVED FROM THE SITE AT THIS TIME.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 22903530 ↗
• InjuryAug 24, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2025, THE PERCEVAL PLUS VALVE, PVF-S WAS IMPLANTED IN AVR SURGERY CONCOMITANT PROCEDURE WITH CABG 3-VESSEL. THE VALVE WAS PLACED WITHOUT ANY PROBLEM, BUT THE PATIENT WAS ON SEVERE DIALYSIS AND HAD DIFFICULTY WITH CENTRAL BYPASS ANASTOMOSIS AND SUTURING THE AORTA INCISION SITE. AFTER ADMINISTRATION OF PROTAMINE IN THE POSTOPERATIVE ICU, PATIENT'S BLOOD PRESSURE DECREASED. AS SUCH, PATIENT WAS PLACED ON ECMO. AFTER THAT, BLEEDING OCCURRED FROM VARIOUS POINTS, AND IT WAS JUDGED THAT HEMOSTASIS WAS DIFFICULT, SO THE PATIENT UNDERWENT REOPERATION, AND PERCEVAL PLUS WAS REMOVED AND BENTALL SURGERY WAS PERFORMED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 22881466 ↗
• InjuryAug 15, 2025Migration; Migration

  ON (B)(6) 2025, THE PERCEVAL PLUS VALVE, PVF-S, WAS IMPLANTED IN THE PATIENT WITHOUT ANY PROBLEM. HOWEVER, THE VALVE MIGRATED WHEN THE HEART MOVED. AS SUCH, THE VALVE WAS EXPLANTED AND REPLACED WITH INSPIRIS (UNKNOWN SIZE). NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 22820275 ↗

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