SOLO SMARTRecalls & reported problems across all models
Corcym Canada Corp · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 3
- Injuries reported
- 16
- Recalls
- 0
We found 4 models of SOLO SMART by Corcym Canada Corp in the FDA's device registry (GUDID). Together they are named in 20 adverse event reports in the FDA's MAUDE database, received between Jun 30, 2016 and Jun 11, 2021 — classified as 3 deaths, 16 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (11 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 SOLO SMART problems
Device problems
- Insufficient Device Problem Information11
- Inadequacy of Device Shape and/or Size2
- Incomplete Coaptation2
- Infusion or Flow Problem2
- Appropriate Device Problem Term/Code Not Available1
- Degraded1
- Difficult to Open or Close1
- Gradient Increase1
Patient problems
- No Information10
- Death3
- Aortic Valve Stenosis2
- Insufficient Information2
- Aortic Insufficiency1
- Aortic Regurgitation1
- Aortic Valve Insufficiency/ Regurgitation1
- Cardiogenic Shock1
SOLO SMART models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SOLO SMART ART23SMTheart-valve, non-allograft tissue2 deaths9 reports
- SOLO SMART ART21SMTheart-valve, non-allograft tissue1 death7 reports
- SOLO SMART ART27SMTheart-valve, non-allograft tissue3 reports
- SOLO SMART ART25SMTheart-valve, non-allograft tissue1 report
Recent SOLO SMART adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJun 11, 2021Insufficient Device Problem Information; Insufficient Device Problem Information
THE MANUFACTURER WAS INFORMED OF THIS EVENT THROUGH THE DEVICE TRACKING DEPARTMENT. BASED ON THE INFORMATION RECEIVED, A SOLO SMART VALVE SIZE 23 WAS IMPLANTED ON (B)(6) 2016. THE PATIENT WILL UNDERGO A VALVE-IN-VALVE PROCEDURE (DATE STILL UNKNOWN). NO FURTHER INFORMATION IS PRESENTLY AVAILABLE. NO ALLEGATION OF A DEVICE MALFUNCTION NOR OF A SERIOUS INJURY WAS RECEIVED FROM THE SITE REGARDING THIS EVENT. PER ADDITIONAL INFORMATION RECEIVED FROM THE HOSPITAL, PRE-OPERATIVELY, THE ECHO SHOWED A SEVERE AORTIC VALVE INSUFFICIENCY. AS SUCH, AN EMERGENCY TAVR VALVE-IN-VALVE WAS PERFORMED FOR CARDIOGENIC SHOCK. THE PROCEDURE WAS PERFORMED ON (B)(6) 2021. A 26 MM SAPIENS 3 VALVE IN VALVE WAS PLACED FROM PERCUTANEOUS FEMORAL APPROACH WITH NO COMPLICATIONS. THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2021.
Patient problems: Insufficient Information
MAUDE report 11982139 ↗InjuryJun 8, 2021Degraded; Insufficient Device Problem Information; Degraded; Insufficient Device Problem Information
THE MANUFACTURER WAS INFORMED OF THIS EVENT THROUGH THE DEVICE TRACKING DEPARTMENT. BASED ON THE INFORMATION RECEIVED, A SOLO SMART VALVE SIZE 23 WAS IMPLANTED ON (B)(6) 2016. THE PATIENT WILL UNDERGO A VALVE-IN-VALVE PROCEDURE (DATE STILL UNKNOWN). NO FURTHER INFORMATION IS PRESENTLY AVAILABLE. NO ALLEGATION OF A DEVICE MALFUNCTION NOR OF A SERIOUS INJURY WAS RECEIVED FROM THE SITE REGARDING THIS EVENT. PER ADDITIONAL INFORMATION RECEIVED FROM THE HOSPITAL, PRE-OPERATIVELY, THE ECHO SHOWED A SEVERE AORTIC VALVE INSUFFICIENCY. AS SUCH, AN EMERGENCY TAVR VALVE-IN-VALVE WAS PERFORMED FOR CARDIOGENIC SHOCK. THE PROCEDURE WAS PERFORMED ON (B)(6) 2021. A 26 MM SAPIENS 3 VALVE IN VALVE WAS PLACED FROM PERCUTANEOUS FEMORAL APPROACH WITH NO COMPLICATIONS. THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2021.
Patient problems: Aortic Valve Insufficiency/ Regurgitation; Cardiogenic Shock; Insufficient Information
MAUDE report 11962738 ↗InjuryNov 20, 2020Infusion or Flow Problem; Infusion or Flow Problem
ON (B)(6) 2018 A PATIENT RECEIVED A SOLO SMART SIZE 27 AORTIC HEART VALVE IMPLANT. THE MANUFACTURER WAS NOTIFIED VIA THE PATIENT TRACKING SYSTEM THAT THE DEVICE WAS EXPLANTED ON (B)(6) 2020 AND REPLACED WITH A PERCEVAL PVS23 SUTURELESS AORTIC HEART VALVE. ADDITIONAL INFORMATION RECEIVED IDENTIFYING THE FOLLOWING. THE PROCEDURE IN 2018 WAS PERFORMED WITHOUT ISSUE. THE PATIENT REQUIRED THE RE-DO PROCEDURE IN 2020 DUE TO SEVERE AS.
Patient problems: Aortic Valve Stenosis
MAUDE report 10878548 ↗InjuryNov 20, 2020Infusion or Flow Problem; Infusion or Flow Problem
ON (B)(6) 2018 A PATIENT RECEIVED A SOLO SMART SIZE 27 AORTIC HEART VALVE IMPLANT. THE MANUFACTURER WAS NOTIFIED VIA THE PATIENT TRACKING SYSTEM THAT THE DEVICE WAS EXPLANTED ON (B)(6) 2020 AND REPLACED WITH A PERCEVAL PVS23 SUTURELESS AORTIC HEART VALVE. ADDITIONAL INFORMATION RECEIVED IDENTIFYING THE FOLLOWING. THE PROCEDURE IN 2018 WAS PERFORMED WITHOUT ISSUE. THE PATIENT REQUIRED THE RE-DO PROCEDURE IN 2020 DUE TO SEVERE AS.
Patient problems: Aortic Valve Stenosis
MAUDE report 10878498 ↗InjurySep 14, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
THE MANUFACTURER RECEIVED INFORMATION ON THIS EVENT THROUGH THE DEVICE TRACKING DEPARTMENT. BASED ON THE INFORMATION REPORTED IN THE PATIENT IMPLANT FORM, A SOLO SMART THAT WAS IMPLANTED ON (B)(6) 2016, WAS EXPLANTED ON (B)(6) 2020. NO FURTHER INFORMATION IS PRESENTLY AVAILABLE.
Patient problems: No Information
MAUDE report 10532726 ↗InjurySep 14, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
THE MANUFACTURER RECEIVED INFORMATION ON THIS EVENT THROUGH THE DEVICE TRACKING DEPARTMENT. BASED ON THE INFORMATION REPORTED IN THE PATIENT IMPLANT FORM, A SOLO SMART THAT WAS IMPLANTED ON (B)(6) 2016, WAS EXPLANTED ON (B)(6) 2020. NO FURTHER INFORMATION IS PRESENTLY AVAILABLE.
Patient problems: No Information
MAUDE report 10532722 ↗InjuryFeb 7, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
BASED ON CAPA (B)(4) INVESTIGATION: THIS CASE REFERS TO A SOLO SMART VALVE SIZE 21, IMPLANTED ON (B)(6) 2015 IN AORTIC POSITION AND REPLACED WITH MITROFLOW VALVE DLA21 ON (B)(6) 2016. NO FURTHER EVENT DETAILS WERE PROVIDED. THIS CASE IS BEING REPORTED TO FDA IN A CONSERVATIVE MANNER.
Patient problems: No Information
MAUDE report 8317285 ↗InjuryFeb 1, 2019Gradient Increase; Gradient Increase
ON (B)(6) 2018, A 65 YEARS OLD FEMALE PATIENT UNDERWENT AORTIC VALVE REPLACEMENT WITH SOLO SMART SIZE 21. DURING THE SAME PROCEDURE, 4 CABGS WERE ALSO PERFORMED. A WEEK LATER, THE PATIENT¿S GRADIENTS WERE UNUSUALLY HIGH: 60MMHG (MEAN) AND 90MMHG (PEAK). THE SURGEON REVIEWED THE ECHO AND DETERMINED THAT THE VALVE WAS OVERSIZED AS WELL AS IMPLANTED TOO HIGH ON ONE SIDE. ON (B)(6) 2019, THE VALVE WAS EXPLANTED AND A MAGNA EASE 19 WAS IMPLANTED INSTEAD. THE PATIENT'S MEAN GRADIENT WENT DOWN TO 16MMHG IMMEDIATELY AFTER THE REPLACEMENT OF THE DEVICE. THE PATIENT IS DOING WELL AFTER THE PROCEDURE. THERE WAS NO PERCEIVED ISSUE WITH THE EXPLANTED SOLO SMART.
Patient problems: No Information
MAUDE report 8298772 ↗InjurySep 24, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
THE MANUFACTURER WAS NOTIFIED OF THE FOLLOWING EVENT VIA THE SURE-AVR PATIENT REGISTRY: A SOLO SMART SIZE 23 WAS IMPLANTED ON (B)(6) 2016. AT THE TIME OF OPERATION, A MEAN GRADIENT OF 11 MMHG AND PARAVALVULAR LEAK 1+ WERE REPORTED. THE PATIENT EXPERIENCED THROMBOCYTOPENIA ON (B)(6) 2016. THE VALVE WAS FUNCTIONING WELL AT FOLLOW UP IN (B)(6) 2017, WITH A MEAN GRADIENT OF 12 MMHG AND NO CENTRAL OR PARAVALVULAR LEAK. THE TOTAL CROSS-CLAMP TIME WAS 59 MINUTES AND THE TOTAL PUMP TIME WAS 72 MINUTES. THE PHYSICIAN REPORTED THAT THE THROMBOCYTOPENIA WAS BELIEVED TO BE ATTRIBUTABLE TO THE SOLO VALVE. ASSAY FOR HEPARIN-INDUCED THROMBOCYTOPENIA WAS NEGATIVE. THE PATIENT WAS NOT TRANSFUSED.
Patient problems: No Code Available
MAUDE report 7904091 ↗InjuryAug 8, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ON (B)(6) 2018, A SOLO SMART SIZE 23 WAS IMPLANTED AND EXPLANTED. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Information
MAUDE report 7764881 ↗DeathFeb 2, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
A SOLO SMART 23 WAS IMPLANTED WITHOUT SUCCESS. UPON RELEASING THE CROSS-CLAMP, THE PATIENT BECAME TACHYCARDIC, REQUIRING MULTIPLE DEFIBRILLATIONS, WITH THE RIGHT VENTRICLE NOT EJECTING. INTRA-OPERATIVE TEE SHOWED THE LEAFLETS DID NOT OPEN CORRECTLY. THE SOLO SMART 23 WAS EXPLANTED AND A SOLO SMART 21 WAS IMPLANTED. THE RIGHT VENTRICLE REGAINED ITS OWN RHYTHM, HOWEVER THE LEFT VENTRICLE WAS COMPLETELY NON-FUNCTIONAL. THE PATIENT REMAINED ON BYPASS AND WAS EVENTUALLY SWITCHED TO ECMO AND TRANSFERRED TO BAYLOR FOR EMERGENT L-VAD, HOWEVER EXPIRED SHORTLY AFTER ARRIVING.
Patient problems: Death; Tachycardia
MAUDE report 7236142 ↗InjuryDec 8, 2017Insufficient Device Problem Information; Insufficient Device Problem Information
THIS EVENT WAS REPORTED TO THE MANUFACTURER THROUGH THE (B)(6) CLINICAL REGISTRY: A SOLO SMART SIZE 23 WAS IMPLANTED ON (B)(6) 2016 VIA MINI- STERNOTOMY. THE VALVE WAS IMPLANTED SUPRA-ANNULAR. ON (B)(6) 2017, THE PATIENT EXHIBITED STROKE AND IT WAS REPORTED BY THE SITE AS UNKNOWN FOR DEVICE RELATION.
Patient problems: Stroke/CVA
MAUDE report 7100507 ↗DeathDec 7, 2017Inadequacy of Device Shape and/or Size; Malposition of Device; Inadequacy of Device Shape and/or Size; Malposition of Device
THIS EVENT WAS REPORTED TO THE MANUFACTURER THROUGH THE (B)(6) REGISTRY: A SOLO SMART SIZE 21 WAS IMPLANTED ON (B)(6) 2016 VIA MEDIAN-STERNOTOMY. THE VALVE WAS IMPLANTED SUPRA-ANNULAR WITH NON-EVERTING SUTURE TECHNIQUE. ON (B)(6) 2017, THE PATIENT EXHIBITED NON STRUCTURAL DYSFUNCTION WHICH WAS REPORTED BY THE SITE AS DUE TO INAPPROPRIATE SIZING AND POSITIONING.
Patient problems: Death; No Information
MAUDE report 7098153 ↗InjuryNov 7, 2017Insufficient Device Problem Information; Insufficient Device Problem Information
ON (B)(4) 2017 THE MANUFACTURER WAS NOTIFIED THROUGH PATIENT TRACKING OF THE FOLLOWING EVENT: ON (B)(6) 2017 AN INTRA-OPERATIVE FAILURE TO IMPLANT OF SOLO SMART SIZE 25 OCCURRED. A CROWN PRT PERICARDIAL HEART VALVE SIZE 25 WAS THEN IMPLANTED. THE DELAY IN THE PROCEDURE IS UNKNOWN AT THIS TIME.
Patient problems: No Information
MAUDE report 7007014 ↗InjuryAug 16, 2017Insufficient Device Problem Information; Insufficient Device Problem Information
ON (B)(4) THE MANUFACTURER WAS NOTIFIED THROUGH PATIENT TRACKING OF A SOLO SMART SIZE 23 DEVICE THAT WAS 'WASTED' ON (B)(6). A CROWN PRT PERICARDIAL HEART VALVE SIZE 21 WAS IMPLANTED ON THE SAME DAY.
Patient problems: No Information
MAUDE report 6799067 ↗
Other Corcym Canada Corp products
All Corcym Canada Corp devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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