International safety notice
Urgent Safety Notice for the products Gelweave™, Thoraflex™ Hybrid, BioValsalva™ Stentless Biplex™ Conduits, Stented BioValsalva™ Biplex™ Conduits and RVOT elan™ Biplex™ Conduits, Vascutek Ltd.
Germany / BfArM · DEU · Aug 21, 2014
Key facts
| Title | Urgent Safety Notice for the products Gelweave™, Thoraflex™ Hybrid, BioValsalva™ Stentless Biplex™ Conduits, Stented BioValsalva™ Biplex™ Conduits and RVOT elan™ Biplex™ Conduits, Vascutek Ltd. |
|---|---|
| Regulator | Germany / BfArM |
| Country | DEU |
| Brand | the products Gelweave™, Thoraflex™ Hybrid, BioValsalva™ Stentless Biplex™ Conduits, Stented BioValsalva™ Biplex™ Conduits and RVOT elan™ Biplex™ Conduits, Vascutek Ltd. |
| Manufacturer | Urgent Safety Notice for the products Gelweave™, Thoraflex™ Hybrid, BioValsalva™ Stentless Biplex™ Conduits, Stented BioValsalva™ Biplex™ Conduits and RVOT elan™ Biplex™ Conduits, Vascutek Ltd. |
| Date | Aug 21, 2014 |
| Regulator page | bfarm.de |
At a glance
- No Recall
- No Field safety notice
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About International device safety notices
Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.
Source: National medical device regulators (as listed), compiled by Orca1