All children's congenital heart surgery has been suspended at Leeds General Infirmary (LGI) with immediate effect.
The temporary suspension follows a number of claims, including some relating to the number of patient deaths, and concerns about surgery standards.
The decision was taken by Leeds Teaching Hospitals NHS Trust after discussions with the NHS Commissioning Board and the Care Quality Commission (CQC).
In light of the talks, Maggie Boyle, the chief executive of Leeds Teaching Hospitals NHS Trust, said it has agreed to carry out an internal review, independently validated and supported by external experts.
"This will look at all aspects of congenital cardiac surgery for children undertaken at the unit in Leeds.
"We have taken the decision to temporarily pause children's congenital cardiac surgery and associated interventions while this review is conducted, a process we would aim to complete in around three weeks."
Acute cardiac surgery will continue.
Sky News Correspondent Gerard Tubb described the suspension of congenital cardiac surgery (to correct heart defects from birth) as "a very serious turn of events".
"It will be enormously distressing news for families expecting to have surgery carried out there," he added.
Shortly after the announcement was made, one mother posted on Facebook: "My son is due for an operation on 18 April. I feel sick at the thought of it not happening."
Ms Boyle said: "We apologise to parents and families who will be affected during this time, and can assure them we always put the safety of our patients first.
"Families whose surgery may be affected during this time are being contacted directly by the trust."
NHS England said the suspension was for checks to be made to ensure the unit is operating safely.
Health Secretary Jeremy Hunt will decide LGI's fateSir Bruce Keogh, the medical director of NHS England, said: "The trust has taken a highly responsible precautionary step.
"Some questions have been raised by the trust's own mortality data and by other information.
"It is important to understand that while this information raises questions, it does not give us answers.
"But it is absolutely right not to take any risks while these matters are being looked into. The priority must be the safety of children."
The CQC said it is "monitoring the situation extremely closely and will not hesitate to take regulatory action if we believe this is required".
The move came only a day after a High Court judge quashed a decision to stop children's heart surgery at the hospital on the ground the consultation process was unfair and legally flawed.
The unit was earmarked for closure as part of an NHS plan to re-organise services across England into fewer, more specialised centres.
Were it to be shut down children would have to be treated at hospitals in Liverpool and Newcastle instead. Its future now lies in the hands of the Health Secretary.
In the meantime, there have been a number of claims that surgeons at LGI have been avoiding referring children to the heart unit at the Freeman Hospital in Newcastle - which would be spared if the original NHS re-organisation plan continues.
The allegations have been strenuously denied by the Leeds Trust.
Following the decision to suspend congenital heart surgery at LGI, Sharon Cheng, from Save Our Surgery - the group which is co-ordinating the fight to keep children's heart surgery in Leeds - said: "We're mystified. We don't know of anything that could justify this step."
The decision to sacrifice the unit in Leeds was taken in July by the Joint Committee of Primary Care Trusts (JCPCT) when it chose seven specialist centres for the future delivery of paediatric cardiac surgery in England.
These were at Great Ormond Street and the Evelina Children's Hospital in London, Newcastle's Freeman Hospital, Birmingham Children's Hospital, Alder Hey in Liverpool, the Royal Children's Hospital in Bristol and Southampton General.
The controversial decision, if it stands, will mean the closure of the children's heart units at LGI as well as Glenfield Hospital in Leicester and London's Royal Brompton.
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