IMPORTANT: Phillips recalls 47,000 units of its HeartStart MRx monitor/defibrillator (Phillips retira 47,000 unidades del Monitor/Desfibrilador HeartStart MRx) March 2017

IMPORTANT: Phillips recalls 47,000 units of its HeartStart MRx monitor/defibrillator (Phillips retira 47,000 unidades del Monitor/Desfibrilador HeartStart MRx) March 2017

Mar 24, 2017 | Tim Casey

Phillips recalled the HeartStart MRx monitor/defibrillator after discovering electrical and battery connection issues that could prevent the device from powering up, charging and delivering an electrical shock therapy.

The FDA announced the recall in a safety alert posted on the agency’s website on March 24.

Phillips recalled 47,632 units in the U.S. that were manufactured from Feb. 11, 2004, to Nov. 4, 2016, and distributed from Feb. 12, 2004, to Nov. 4, 2016.

Medical professionals who are trained in CPR use the HeartStart MRX to pace people with a slow heartbeat or deliver shocks to people with sudden cardiac arrest.

In February, Phillips sent an “Urgent Medical Device Correction” notice to its customers, according to the FDA. The company said that the device could stop pacing and lead to delays in delivering therapy, which could result in permanent organ damage, brain injury or death.

The FDA classified the action a Class I recall, which the agency defines as “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”

The recall affects the following model numbers: 

M3535A (M3535ATZ) 

M3536A (M3536ATZ)

M3536M

M3536MC

M3536M2

M3536M4

M3536M5

M3536M6

M3536M7

M3536M8 

M3536M9.

FDA approves less-invasive heart defibrillator

FDA approves less-invasive heart defibrillator

New device uses wires that sit just below skin's surface and do not need to be threaded through heart's blood vessels

 September 30, 2012

 The Associated Press

WASHINGTON — The Food and Drug Administration says it has approved a first-of-a-kind heart-zapping implant from Boston Scientific that that does not directly touch the heart.

Implantable defibrillators use thin wires to send electrical signals that disrupt dangerous heart rhythms. Surgeons have traditionally connected the wires to the heart through a blood vessel in the upper chest.

The new device from Boston Scientific uses wires that sit just below the skin's surface and do not need to be threaded through the heart's blood vessels.

Natick, Mass.-based Boston Scientific Corp. acquired the device through a $150 million buyout of San Clemente, Calif.-based Cameron Health. Under the terms of the deal, Boston Scientific will pay an additional $150 million for FDA approval, plus up to $1 billion in payments based on future sales figures.

Link information web

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Related:

EU Issues OK for Minimally Invasive Subcutaneous Implantable Defibrillator