Manufacturer Novo Nordisk is recalling certain batches of NovoPen® Echo® and NovoPen® 5 over fears the insulin cartridge holder could crack, leading to under-delivery of insulin and hyperglycaemia.
Novo Nordisk said this component of the devices can be ‘structurally compromised’ if exposed to certain chemicals – including household cleaning products.
Patients with diabetes using the products from the affected batches should contact Novo Nordisk to replace the cartridge holder.
Details of the affected batches can be found here.
John Wilkinson, director of medical devices at the Medicines and Healthcare products Regulatory Agency (MRHA), said: ‘This is a company-led recall and we are supportive of the proactive approach being taken by Novo Nordisk.
‘It is important patients do not stop treatment without contacting their diabetes management team. We are asking people using a NovoPen® Echo® and/or NovoPen® 5 from one of the affected batches to contact Novo Nordisk to replace the cartridge holder as some could be damaged or subject to damage in the future.
We continue to encourage people to report any issues involving medical devices to the MHRA via our Yellow Card Scheme.’
Dan Howarth, head of care at the charity Diabetes UK, said: ‘Ensuring the correct level on insulin is vitally important in the management of diabetes; so it’s important that anyone affected by this recall contact Novo Nordisk to arrange for a replacement cartridge holder.
‘If they have any concerns about their level of insulin they should consult with their diabetes care team.’