Medtronic Inc. recalls Medtronic InSync III, model 8042, 8042B and 8042U. Implantable pulse generator pacemaker.

Recall date

November 9, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0342-2016

FDA classification

Class II

Brand / firm

Medtronic Inc.

Sold / distributed

Worldwide Distribution - USA (nationwide) including Puerto Rico and to Algeria, Argentina, Armenia, Australia, Austria, Bangladesh, Belarus, Belgium, Bermuda, Bolivia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador…

Why it was recalled

Medtronic has confirmed an issue with InSync III CRT-pacemaker devices related to long-term battery performance. The root cause is unexpected high battery impedance.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Medtronic InSync III, model 8042, 8042B and 8042U. Implantable pulse generator pacemaker.