More than 100,000 UK patients must have their pacemaker replaced or its software updated after some of the devices were found to run out of battery years early.
Manufacturer Boston Scientific has issued a safety notice to NHS trusts warning around 13 per cent of its 'Accolade' pacemakers made before September 2018 have a battery flaw.
It means they are more likely to switch suddenly into a limited 'safety mode', which can be fatal for some people who are fully reliant on the gadget to regulate their heart rhythm.
Two patients have died and over 800 injuries have been linked to the faulty devices in the United States.
The Medicines and Healthcare products Regulatory Agency told the Health Service Journal that 13,969 devices impacted by the flaw were sold to 153 hospitals in the UK.
Boston Scientific issued a software update for the problem last autumn and said it should be installed to all Accolade pacemakers via in-person appointments.
The MHRA said this means a further 97,557 devices across 308 UK hospitals, in addition to the initial 13,969, should be updated.
The recall affects people who had one of the faulty devices fitted between 2015 and 2018, mainly for slow or irregular heart rhythms.
They were meant to have a 10-year battery life but instead sometimes switch to safety mode after six years.
Hospitals are now in the process of contacting affected patients.
Professor Simon Ray, clinical director for heart disease at NHS England, told HSJ: 'While all pacemakers will need their battery replaced eventually, a small proportion of patients affected by this will need to have them replaced early.
'Patients affected will be contacted by their local hospital and reviewed by an expert clinical team, who will decide if they require an early replacement.
'People should continue to attend their usual pacemaker follow-up appointments.'
The software update means that patients will typically not require an operation to replace the faulty device.
Instead, the software should be updated and patients monitored.
However, the MHRA said it is aware that 89 early device replacement surgeries had been carried out, and 51 normal device replacement surgeries performed due to the pacemakers entering safety mode.
Despite the release of the software upgrade last September, a further 88 early device replacement surgeries and 23 normal device replacement surgeries have been carried out since then.
Royal Wolverhampton Trust has identified 912 impacted patients and has replaced 53 pacemakers to date.
Its January board papers say: 'This is deemed to be a national concern and has been escalated accordingly.'
Papers seen by the HSJ also indicated RWT was considering whether it would be compensated by Boston Scientific to cover the additional costs.
The trust said the firm had approached it about compensation for the procedures but it was unclear if it would be enough to cover the costs.
In other cases, Norfolk and Norwich University Hospitals said a year ago it had identified 580 patients with faulty pacemakers, with 72 patients at high risk.
And a woman from Southport is suing Boston Scientific after she had two pacemakers fail.