CryoValve® SG Pulmonary Human Heart Valve SGPV00Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00877234000447), received between Nov 3, 2021 and Sep 4, 2025 — classified as 1 death, 7 injuries.

The most frequently reported specific device problem is “Gradient Increase” (1 report).

3 FDA recall records name this device's identifier, 2 still open.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. May 28, 2024Class IIOpen, Classified

   Grafts were found to have been approved, released, shipped and implanted with an invalid test results.

   Z-2531-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Mar 6, 2024Class IIOpen, Classified

   The blood cultures performed as part of the organ donation process were positive for Staphylococcus aureus.

   Z-1545-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

3. Nov 10, 2020Class IITerminated

   On November 10, 2020, it was discovered that there are post- processing microbial culture test failures for other allografts, processed using a TRIS saline solution lot that was also used in processing allografts subjected to the recall.

   Z-0652-2021 · Root cause: Material/Component Contamination · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE IMPLANT SUMMARY CARD RECEIVED PREVIOUSLY IMPLANTED ARTIVION TISSUE WAS EXPLANTED FROM A PATIENT ON (B)(6) 2024. ARTIVION IMPLANT DATABASE REVEALED SGPV00 SERIAL NUMBER: (B)(6) FOR THIS PATIENT. THIS INVESTIGATION IS RELEGATED TO SGPV00 SERIAL NUMBER: (B)(6) WITH ALLEGATION OF EXPLANT DUE TO REPAIR OF PSEUDOANEURYSM.

  Patient problems: Pseudoaneurysm

  MAUDE report 22967209 ↗
• InjuryAug 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE IMPLANT SUMMARY CARD RECEIVED PREVIOUSLY IMPLANTED ARTIVION TISSUE WAS EXPLANTED FROM A PATIENT ON (B)(6) 2025. A QUERY OF THE ARTIVION IMPLANT DATABASE PRODUCED SGPV00 SERIAL NUMBER: (B)(6) THAT WAS IMPLANTED ON (B)(6) 2019. THIS INVESTIGATION IS RELEGATED TO SGPV00 SERIAL NUMBER: (B)(6) WITH THE ALLEGATION OF EXPLANT DUE TO UNKNOWN INDICATION.

  Patient problems: Insufficient Information

  MAUDE report 22871827 ↗
• InjuryAug 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE IMPLANT SUMMARY CARD PREVIOUSLY IMPLANTED TISSUE WAS EXPLANTED FROM A PATIENT ON (B)(6) 2025. A QUERY OF THE ARTIVION IMPLANT SUMMARY DATABASE PRODUCED SGPV00 SERIAL NUMBER: (B)(6) IMPLANTED ON (B)(6) 2010.

  Patient problems: Pulmonary Valve Stenosis; Unspecified Heart Problem

  MAUDE report 22685544 ↗
• InjuryNov 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PUBLICATIONS, ¿FATE OF THE AUTOGRAFT AND HOMOGRAFT FOLLOWING ROSS AORTIC VALVE REPLACEMENT: REOPERATIVE FREQUENCY, OUTCOME, AND MANAGEMENT¿. THE JOURNAL OF HEART VALVE DISEASE 2006;15:253-260. AND ¿THE ROSS FULL ROOT REPLACEMENT IN ADULTS WITH BICUSPID AORTIC VALVE DISEASE¿. THE JOURNAL OF HEART VALVE DISEASE 2011;20:332-340. ARE RETROSPECTIVE REVIEWS REPORTING ON THE OUTCOMES OF SYNERGRAFT® PULMONARY VALVES (CRYOLIFE®, SGPV00) AND STANDARD PROCESSED CRYOPRESERVED PULMONARY VALVES (CRYOLIFE, PV00) USED FOR PULMONARY VALVE REPLACEMENTS; HOWEVER THE REPORTED OUTCOMES DO NOT DIFFERENTIATE RELATION TO PROCESSING METHOD. THE MANUSCRIPTS COLLECTIVELY COVER IMPLANTS FROM 1993 ¿ 2009. GIVEN THE OVERLAP OF THE REPORTING PERIOD OF THE 2 PUBLICATIONS, IT IS UNCLEAR WHICH PATIENTS ARE MUTUALLY EXCLUSIVE TO EITHER PUBLICATION. HOWEVER, IT APPEARS THE 2011 PUBLICATION IS A SUBSET OF THE ORIGINAL SERIES OF 167 PATIENTS: 22 SGPV, 140 STANDARD PV AND 5 GLUT FIXED BOVINE JUGULAR VEIN. HOMOGRAFT DYSFUNCTION WITH OBSTRUCTION, STENOSIS, REGURGITATION/INSUFFICIENCY, AND REOPERATION WERE NOTED IN THE HOMOGRAFTS USED FOR RECONSTRUCTION OF THE RIGHT VENTRICULAR OUTFLOW TRACT (RVOT). THIS REPORT IS RELEGATE

  Patient problems: Obstruction/Occlusion; Stenosis; Valvular Insufficiency/ Regurgitation

  MAUDE report 20611182 ↗
• DeathNov 4, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ACCORDING TO THE NOTIFICATION FROM "TWO PUBLICATIONS WERE REVIEWED RELATED TO THE CANADIAN ROSS REGISTRY DATABASE, THE PUBLICATIONS ARE AS FOLLOWS: ¿PULMONARY HOMOGRAFT DYSFUNCTION AFTER THE ROSS PROCEDURE USING DECELLULARIZED HOMOGRAFTS¿A MULTICENTER STUDY¿. J THORAC CARDIOVASCSURG 2022;163:1296-305. ¿THE ROSS PROCEDURE IS A SAFE AND DURABLE OPTION IN ADULTS WITH INFECTIVE ENDOCARDITIS: A MULTICENTRE STUDY¿. EUROPEAN JOURNAL OF CARDIO-THORACIC SURGERY 58 (2020) 537¿543. BOTH MANUSCRIPTS ARE MULTICENTER RETROSPECTIVE REVIEWS OF SYNERGRAFT® PULMONARY VALVES (CRYOLIFE®/ARTIVION®, SGPV00) USED FOR THE ROSS PROCEDURE. THE MANUSCRIPTS COLLECTIVELY COVER IMPLANTS FROM 2000 ¿ 2019, WITH THE OVERALL USE OF 466 SGPV VALVES. IT APPEARS THE 2020 PUBLICATION MAY BE A SUBSET OF THE LARGER 2022 DATASET. PULMONARY STENOSIS AND REOPERATION WERE NOTED IN THE SERIES AS WELL AS REINFECTION IN THE SUBGROUP OF PATIENTS PRESENTING WITH ENDOCARDITIS IN THE 2020 SERIES. AUTHORS CONCLUDE ¿THE USE OF DECELLULARIZED CRYOPRESERVED PULMONARY HOMOGRAFTS RESULTS IN A LOW INCIDENCE OF DYSFUNCTION AND REINTERVENTION AFTER THE ROSS PROCEDURE.¿ ¿IN SELECTED PATIENTS WITH IE, THE ROSS PROCEDURE IS A SAFE AND REASONAB

  Patient problems: Endocarditis; Stenosis; Stroke/CVA

  MAUDE report 20600408 ↗
• InjuryOct 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL NOTIFICATION, "THE PUBLICATION TITLED ¿FIFTY-TWO MONTHS¿ MEAN FOLLOW UP OF DECELLULARIZED SYNERGRAFT¿-TREATED PULMONARY VALVE ALLOGRAFTS¿ THE JOURNAL OF HEART VALVE DISEASE 2008;17:98-104: IT IS A RETROSPECTIVE REVIEW WHICH COMPARES SYNERGRAFT® PULMONARY VALVES (CRYOLIFE®, SGPV00) TO STANDARD PROCESSED CRYOPRESERVED PULMONARY VALVES (CONTROLS, UNKNOWN PROCESSOR) USED FOR THE ROSS PROCEDURE. THE MANUSCRIPT COVERS IMPLANTS FROM 2000 ¿ 2002, WITH THE USE OF 23 SGPV COMPARED TO 49 STANDARD PROCESSED VALVES. REGURGITATION (INSUFFICIENCY) WAS NOTED IN THE SGPV RECIPIENTS, AND ALSO NOTED TO BE HIGHER THAN THAT SEEN IN THE CONTROL GROUP. THE AUTHORS CONCLUDE IT APPEARS THAT THE USE OF PULMONARY SYNERGRAFT-ALLOGRAFT VALVES DOES NOT PROVIDE ANY MAJOR ADVANTAGE OVER CONVENTIONAL ALLOGRAFTS."

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 20462898 ↗
• InjuryDec 18, 2023Gradient Increase; Gradient Increase

  ACCORDING TO INITIAL NOTIFICATION: "(B)(6) 2023 PATIENT HAD A 26MM PULMONARY HOMOGRAFT IMPLANTED ON RIGHT SIDE AND ON-X AAP ON LEFT SIDE. SURGEON SAYING THE HOMOGRAFT IS "SQUISHED" NOW." 12/13/2023 ADDITIONAL INFO RECEIVED FROM SURGEON: "UPON REVIEW OF THE RECENT CT SCAN FROM THIS WEEK AND REEXAMINING THE RECONSTRUCTED IMAGES, IT APPEARS THAT THE CRYOPRESERVED PULMONARY HOMOGRAFT HAS UNDERGONE A SIGNIFICANT INFLAMMATORY CHANGE AND DESICCATION. THE RV TO PA CONDUIT WHICH IS A 26 MM HOMOGRAFT APPEARS TO HAVE SHRUNKEN TO 7 OR 8 MM AT ITS LARGEST DIAMETER. THERE IS NO EVIDENCE OF PSEUDOANEURYSM, HEMATOMA OR LEAK AT ANY SUTURE SITE, AND LEFT SIDED PROSTHESIS LOOKS APPROPRIATELY DILATED TO MAXIMUM SIZE. AN INFLAMMATORY RIND AROUND THE LEFT-SIDED ROOT PROSTHESIS AND THE RIGHT SIDED PROSTHESIS CAN BE APPRECIATED. THE PLANNED STRATEGY IS TO PURSUE BALLOONING OF THE RV TO PA CONDUIT WHILE PROTECTING THE LEFT MAIN CORONARY ARTERY. IF THIS IS SUCCESSFUL, THERE MAY BE AN OPPORTUNITY TO TEMPORIZE WITH A STENT IF LMCA IS NOT COMPROMISED. IF THE PATIENT REMAINS HEMODYNAMICALLY STABLE AND IS OTHERWISE NOT HAVING SIGNIFICANT SYMPTOMS, MAYBE WE COULD MEDICALLY OPTIMIZE HER RVSP OF APPROXIMATELY 60 MM

  Patient problems: Inflammation; Stenosis

  MAUDE report 18347425 ↗
• InjuryNov 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE IMPLANT SUMMARY CARD RETURNED FROM THE USER FACILITY INDICATING THAT CRYOLIFE TISSUE WAS EXPLANTED FROM A PATIENT ON (B)(6) 2021. A QUERY OF THE CRYOLIFE IMPLANT TRACKING DATABASE REVEALED THE PATIENT HAD A SGPV00 SERIAL NUMBER: (B)(6) IMPLANTED ON (B)(6) 2018.

  Patient problems: Unspecified Heart Problem

  MAUDE report 12745055 ↗