Reported Oct 18, 2017 · Terminated
Unify, Model Numbers: CD3231-40 and CD3231-40Q; Unify Quadra, Model Numbers: CD3249-40 and CD3249-40Q; Unify Assura,…
St Jude Medical Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.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?
5 of 5 products
| # | Product as published |
|---|---|
| 1 | Unify, Model Numbers: CD3231-40 and CD3231-40Q |
| 2 | Unify Quadra, Model Numbers: CD3249-40 and CD3249-40Q |
| 3 | Unify Assura, Model Numbers: CD3257-40, CD3257-40Q, CD3357-40C, CD3357-40Q |
| 4 | Quadra Assura, Model Numbers: CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q |
| 5 | Quadra Assura MP, Model Numbers: CD3269-40, CD3269-40Q, CD3369-40C, CD3369-40Q Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing |
- Lot codes and dates
- Serial Numbers
3,965 of 3,965 codes
591144617036625707700853562987464126062799763822610177741043239101843610028117012648700555461634359329759581576013060717563394871754810036427219977956987476876384225929346373687454387438747393288058737889977548566052005936436188956073526227566226146148767903296132026133367616826068306057986070416031576356306403597465148074317956841043148597053628368612783633942624009
- Serial Numbers
- Amount recalled
- 89,109 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
The device may exhibit premature battery depletion.
Using this product could cause serious injury, illness or death — stop using it now.
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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