Latest update on BioIntegral Surgical and ongoing availability of their devices in the UK

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16 August 2022

On the 14th July 2022, BioIntegral Surgical issued a follow-up Field Safety Notice (FSN), advising customers that no microbial growth had occurred in any devices sampled for laboratory testing, with dozens subject to culture testing out to 14 weeks (as at 14th July 2022). These notices apply to the 5 device types listed below.

1st FSN

FSN issued by Biointegral Surgical on 13th April 2022

Follow-up FSN

FSN issued by Biointegral Surgical on 14th July 2022

In addition, effective 15th July 2022, BioIntegral Surgical elected to voluntarily withdraw all of the company's CE Mark certificates, including for devices outside of the product hold, effectively removing them from the UK market. The manufacturer has made clear that this was purely a business decision affecting all their devices, and not related to any product concerns or non-conformities.

It is important to note that this action does not affect product which pre-dates the withdrawal of the relevant certification. Implications for unused Biointegral devices are as follows:

Devices outside the scope of the FSN (listed below) remain available for use until hospital or distributor stocks are depleted

PerimaTM BioModified Non-valved Conduit, Biological Vascular Graft – Peripheral (NVC-P)

PerimaTM BioModified Non-valved Conduit, Biological Vascular Graft – Thoracic (NVC-A)

PerimaTM BioModified Non-valved Conduit, Bifurcated Biological Vascular Graft (NVC-B)

No-React® Porcine pericardial patch (NRPP)

Devices within the scope of the FSN (listed below) remain subject to the manufacturer’s voluntary product hold.

No-React® BioConduit (NRAC),

No-React® BioPulmonic Conduit (NRPC),

No-React® Injectable BioPulmonic (NRIP),

No-React® BioMitral (NRM),

No-React® BioAortic (NRA)

You will be updated if there are any significant changes to this position.

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