Perceval Sutureless Heart Valve Warning [Canada]


Canada FlagCanada/Ottawa: Perceval Sutureless Heart Valve Warning [Canada]LivaNova Canada Corp., a Burnaby, British Columbia establishment, issues warning concerning an unknown number of Perceval Sutureless Heart Valves due to “stent folding” and consequential risks of operational failure and need for surgical re-operation, all serious health and safety hazards.

HCSC: http://ht.ly/YSvY30kNvvC

Direct link: http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2018/67146r-eng.php

Additional information:
Health Canada/Santé Canada (“HCSC”) reports the following Heart Valves are subject to this warning notification:

  • Perceval Sutureless Heart Valves, sold with a model/catalog number of PVS21
  • Perceval Sutureless Heart Valves, sold with a model/catalog number of PVS23
  • Perceval Sutureless Heart Valves, sold with a model/catalog number of PVS25
  • Perceval Sutureless Heart Valves, sold with a model/catalog number of PVS27

Please consult the photograph above for details of the product’s design and visual presentation.

==> No barcodes, UPCs, item numbers or other identification numbers were listed with this recall notification.

According to Health Canada, LivaNova has recently become aware of more than anticipated cases of valve insufficiency, primarily caused by oversizing leading to “stent folding”. Moreover, patients with implanted Perceval Valves may experience valve folding when emergency cardiovascular procedures, such as CPR, are administered post-implant.

Valve folding could result in Paravalvular or central leakage, high gradient, which may be significant enough to require reoperation. LivaNova is providing clarifications about this adverse event and recommendations to prevent its occurrence. There is no market withdrawal at this time.

If you have any questions about this warning notification and are a physician, surgeon or other healthcare professional, please contact the company using the Web form available here:

==> http://www.livanova.com/contact-us/form#healthcare_professional

If you have any questions about this warning notification and are a patient or family member, please contact the company using the Web form available here:

==> http://www.livanova.com/contact-us/form#patient

==> To see other warnings, recalls and notifications caused by suspected faulty and/or dangerous Medical Equipment or Implanted Devices, please search for “medical” using the Search Box at the top of this page.

==> To see other warnings, recalls and notifications for products manufactured, marketed and/or sold by LivaNova Canada Corp., please search for “LivaNova” using the Search Box at the top of this page.

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More information about this warning:
HCSC ID number: RA-67146
Recalls Direct RIN: 10358-2018
Want to read more about this warning?
==> Please click on the links above to visit the originating site.
Want to read more about other recalls or warnings?
==> Please click on the links below.

General information:
More recalls? Back to the main Recalls Direct page:
==> http://www.RecallsDirect.com/
About the Recalls Direct service:
==> http://wp.me/P2bVty-2
Visit the Living Safely site:
==> http://www.LivingSafely.org/
Report an unsafe product you purchased in Canada [external: new window opens]:
==> http://www.hc-sc.gc.ca/cps-spc/advisories-avis/incident/index-eng.php
Search for a recalled product on the Health Canada Web site [external: new window opens]:
==> http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/index-eng.php

We welcome your feedback:
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E. & O. E.

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