Reported Nov 2, 2016 · Terminated
Fortify VR, Model No. CD1231-40, CD1231-40Q. Fortify ST VR, Model No. CD1241-40, CD1241-40Q. Fortify Assura VR, Model…
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?
7 of 7 products
| Model / number | Product as published |
|---|---|
CD1231-40 | CD1231-40Q. Fortify ST VR |
CD1241-40 | CD1241-40Q. Fortify Assura VR |
CD1257-40 | CD1257-40Q, CD1357-40C. Fortify Assura ST VR |
CD1263-40 | CD1263-40Q, CD1363-40, CD1363-40Q. Fortify DR |
CD2231-40 | CD2231-40Q. Fortify ST DR |
CD2241-40 | CD-2241-40Q, CD2263-40, CD2363-40C, CD2363-40Q. Fortify Assura DR |
CD2257-40 | CD2257-40Q, CD2357-40C, CD2357-40Q. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided 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. 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
4,074 of 4,074 codes
607591607592607593607594607595607596607597607598607599607600607801607802607803607804607805607806607807607808607809607810607811607812607813607814607815607816607817607818607819607820607911607912607913607914607915607916607917607918607919607920607921607922607923607924607925607927607928607929607930608221608222608223608224608225608226608227608228608229608230608231
- Serial
- Amount recalled
- 204,785 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
St Jude Medical is recalling implantable cardiac defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices because they are subject to premature battery depletion due to lithium cluster with the battery causing a short circuit.
Using this product could cause serious injury, illness or death — stop using it now.
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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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