The flaw that likely caused Medtronic’s massive ICD and CRT-D recall — and why they’re too risky to replace

Medtronic has recalled implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators that may fail to deliver life-saving shocks for cardiac patients. [Photo courtesy of Medtronic]

Medtronic identified a likely design flaw that can cause defibrillator implants to halt life-saving shocks for cardiac patients.

An insulation defect appears to be to blame for Medtronic’s massive Class I recall of implantable cardioverter defibrillators (ICDs), including cardiac resynchronization therapy defibrillators (CRT-Ds).

The FDA said it has not yet determined a cause and that Medtronic is investigating. But Medtronic — the world’s largest medical device manufacturer — identified the likely problem in an urgent medical device correction notice sent to healthcare providers.

Medtronic identified 348,616 devices in the U.S. for the recall, distributed from Oct. 13, 201…

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Novartis temporarily halts production of two radioligand therapy medicines

Novartis (NYSE:NVS) announced that it had voluntarily stopped the production at radioligand therapy plants in Ivrea, Italy and Millburn, New Jersey, over possible quality concerns.

In a statement, the company explained it had made the decision “out of an abundance of caution due to potential quality issues identified in its manufacturing processes.”

As a result, it will stop the distribution of Lutathera (USAN: lutetium Lu 177 dotatate; INN: lutetium (177Lu) oxodotreotide in the U.S. and Canada, and Pluvicto (lutetium Lu 177 vipivotide tetraxetan).

The company plans to investigate further before resuming the production of the two radioligand therapies.

The company anticipates having some supply of the two drugs in the next six weeks.

In the meantime, the company can continue distributing Lutathera in Europe and Asia from a site in Zaragoza, Spain. Novartis, however, acknowledges that the supply of the drugs may be limited.

The compan…

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Smiths Medical has a serious infusion pump recall

Smiths Medical announced that it has become aware of an issue in which certain Medfusion syringe pumps may not operate as expected.

Minneapolis-based Smiths Medical said in a news release that certain Medfusion 3500 and 4000 syringe pumps with specific firmware versions may provide over-delivery or under-delivery of a bolus or loading dose when one of those doses is interrupted, followed by a specific sequence of events due to a software error. The issue could result in serious injury or death.

Get the full story at our sister site, MassDevice.

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