Reported Dec 9, 2015 · Terminated
Medtronic InSync III, model 8042, 8042B and 8042U. Implantable pulse generator pacemaker.
Medtronic Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Inc. · 8200 Coral Sea St Ne · Saint Paul, MN · 55112-4391
Is this the product you have?
- Medtronic InSync III, model 8042, 8042B and 8042U. Implantable pulse generator pacemaker.
- Lot codes and dates
- Manufactured Serial NumbersPK
2,714 of 2,714 codes
PKF100010HPKF100011HPKF100012HPKF100013HPKF100014HPKF100015HPKF100016HPKF100018HPKF100019HPKF100020HPKF100021HPKF100022HPKF100023HPKF100024HPKF100025HPKF100026HPKF100027HPKF100028HPKF100029HPKF100030HPKF100031HPKF100032HPKF100033HPKF100034HPKF100035HPKF100036HPKF100037HPKF100038HPKF100039HPKF100040HPKF100041HPKF100042HPKF100043HPKF100044HPKF100045HPKF100046HPKF100047HPKF100048HPKF100049HPKF100050HPKF100051HPKF100052HPKF100053HPKF100054HPKF100055HPKF100056HPKF100057HPKF100058HPKF100059HPKF100060HPKF100061HPKF100062HPKF100063HPKF100064HPKF100065HPKF100066HPKF100067HPKF100068HPKF100069HPKF100070H
- Manufactured Serial Numbers
- Amount recalled
- 96,787
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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