Reported Oct 25, 2017 · Terminated
PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI These low voltage (LV) devices are implantable pacemaker pulse…
St Jude Medical 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: St Jude Medical Inc. · 15900 Valley View Ct · Sylmar, CA · 91342-3577
Is this the product you have?
- PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.
- Lot codes and dates
- Serial Numbers
3,621 of 3,621 codes
447122344356204471226447825944739234465800446579529601234471236446586629601194480805445662644566054456614445660944556654470374299221544702514478226299220644355324436165444255728887462992230447024929922194481080447711144866032992337447824630283824470221299233644702564470255447714544771542992244447910144702152817358289778428977792897791287849929121022912129291213729121634427305299229429922702992271287062728887482912140
- Serial Numbers
- Amount recalled
- 4828 units
This recall covers 10 products
The agency filed one notice per product. You are reading one of them; the other 9 are below.
Why it was recalled
New pacemaker firmware was developed to further mitigate the risk of unauthorized access to our pacemakers that utilize radio frequency (RF) communications.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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