Reported Oct 25, 2017 · Terminated
Assurity MRI Model Numbers: PM1272, PM2272 Implantation of a single-chamber pulse generator, dual-chamber 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?
- Assurity MRI Model NumbersPM1272, PM2272 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more
- of the following permanent conditionsSyncope, Presyncope, Fatigue, Disorientation, Or any combination of those symptoms. Implantation
- of a CRT-P is indicated forMaintaining synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class II or III heart failure. The reduction of the symptoms of moderate to severe heart failure (NYHA Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction d35% and a prolonged QRS duration
- Lot codes and dates
- Serial Numbers4
3,620 of 3,620 codes
461409945962164596638472786346115104614078461186146118764635855461682547281024619514461191946210314621034462037246204954618816477804646472794739147465215446113554611962478100647827454762369458075045806994727919473722147278464740088474069747367694740335472701247279174738401464101445806844617156462141346485984647009466213846210774652686465252646455824621012461740246475444611377461793847822924782687476238747822294737273
- Serial Numbers
- Amount recalled
- 164366 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.
Want the full recall guide?
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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