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Fetal shunts - New Advice from Medicines and Healthcare products Regulatory Agency (MHRA

Fetal shunts - New Advice from Medicines and Healthcare products Regulatory Agency (MHRA

11 November 2020

The MHRA has reviewed the academic evidence surrounding the use of fetal shunts, as well as consulting with clinicians in the field, and found that the risk posed by the Rocket Medical device constructed from the inferior materials is greater than its clinical benefit. We are also informed that the Rocket and Cook (Harrison shunt) devices are functionally similar and an experienced operator should be able to navigate the change of device, with little to know additional risk to the patient.

Rocket Medical are currently testing a newly procured material and aiming to return the conforming device to the market ASAP, but this will not be before 23 November 2020 at the earliest.