SOLO SMART ART27SMTRecalls & reported problems
Corcym Canada Corp · Class 3 · Implant
All models of SOLO SMART (4)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00896208000498), received between Nov 29, 2016 and Nov 20, 2020 — classified as 3 injuries.
The most frequently reported specific device problem is “Infusion or Flow Problem” (2 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, 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 16, 2026.
Most reported problems
Device problems
- Infusion or Flow Problem2
- Incomplete Coaptation1
Patient problems
- Aortic Valve Stenosis2
- No Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
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 ↗InjuryNov 29, 2016Incomplete Coaptation; Incomplete Coaptation
THE MANUFACTURER WAS NOTIFIED ON 01-NOV-2016 BY THE PATIENT OF THE FOLLOWING: A SOLO SMART VALVE WAS IMPLANTED ON (B)(6) 2015. ONE OF THE LEAFLETS WAS NOT CLOSING. THE PATIENT IS SCHEDULED FOR VALVE-IN-VALVE REOPERATION.
Patient problems: No Information
MAUDE report 6133861 ↗
Other heart-valve, non-allograft tissue devices
- INSPIRIS RESILIA AORTIC VALVE 11500AEdwards Lifesciences LLC · Heart-Valve, Non-Allograft Tissue2 deaths404 reports
- INSPIRIS RESILIA AORTIC VALVE 11500AEdwards Lifesciences LLC · Heart-Valve, Non-Allograft Tissue385 reports
- PERCEVAL PVS23Corcym Canada Corp · heart-valve, non-allograft tissue26 deaths337 reports
- MOSAIC® 305C23Medtronic, Inc. · heart-valve, non-allograft tissue327 reports
- MOSAIC® 305C25Medtronic, Inc. · heart-valve, non-allograft tissue2 deaths324 reports
- FREESTYLE® FR995-27Medtronic, Inc. · heart-valve, non-allograft tissue2 deaths318 reports
- FREESTYLE® FR995-29Medtronic, Inc. · heart-valve, non-allograft tissue288 reports
- FREESTYLE® FR99525Medtronic, Inc. · heart-valve, non-allograft tissue2 deaths280 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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