Reported Oct 18, 2017 · Terminated
Fortify VR - Model Numbers: CD1231-40 and CD1231-40Q; Fortify ST VR, Model Numbers: CD1241-40 and CD1241-40Q; Fortify…
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?
8 of 8 products
| # | Product as published |
|---|---|
| 1 | Fortify VR - Model Numbers: CD1231-40 and CD1231-40Q |
| 2 | Fortify ST VR, Model Numbers: CD1241-40 and CD1241-40Q |
| 3 | Fortify Assura VR, Model Numbers: CD1257-40, CD1257-40Q, CD1357-40C, CD1357-40Q |
| 4 | Fortify Assura ST VR, Model Numbers: CD1263-40, CD1263-40Q, CD1363-40C, CD1363-40Q |
| 5 | Fortify DR, Model Numbers: CD2231-40 and CD2231-40Q |
| 6 | Fortify ST DR, Model Numbers: CD2241-40 and CD2241-40Q |
| 7 | Fortify Assura DR, Model Numbers: CD2257-40, CD2257-40Q, CD2357-40C, CD2357-40Q |
| 8 | Fortify Assura ST DR, Model Numbers: CD2263-40, CD2263-40Q, CD2363-40C, CD2363-40Q Product Usage 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 |
- Lot codes and dates
- Serial Numbers6
4,046 of 4,046 codes
10720921072099107209561041464575464513664398071954611764941176492741560810336630647643609116169875618973639011616946108467330157173627888497600667003656622669627017627314627696610840612400741610737607705649733310738921745376754552727079725262795252789466644370607810616517625042633253625041632204642059645143629082737580789446757787709960729842755858789525625869619824
- Serial Numbers
- Amount recalled
- 90,563 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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