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FDAMay 22, 2024device

Abbott Infinity 5, Implantable Pulse Generator, REF: 6661, SterileEO, Rx Only

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Their is a potential that the implantable pulse generator replacement indicator and end of service date may be shorter than indicated in the product labeling potentially resulting in loss of therapy.

What to do

FDA enforcement status: Ongoing

Brands named

abbott medicalabbott

UPCs

05415067020253

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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