Reported Feb 20, 2013 · Terminated
St. Jude Medical, AGA Medical corporation, AMPLATZER¿ TorqVue¿ FX Delivery System. Model #'s: 9-ITVFX06F45/60,…
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 · 177 E County Road B · Saint Paul, MN · 55117-1951
Is this the product you have?
- St. Jude Medical, AGA Medical corporation, AMPLATZER¿ TorqVue¿ FX Delivery System. Model #'s: 9-ITVFX06F45/60, 9-ITVFX07F45/60, 9-ITVFX007F45/80, 9-ITVFX08F45/60, 9-ITVFX08F45/80, 9-ITVFX09F45/80, 9-ITVFX10F45/80 9-ITVFX12F45/80, 9-ITVFX13F45/80. Cardiac surgical instrument, used to close atrial septal defects between the right and left atriums.
- Lot codes and dates
- all batches
- Amount recalled
- 635
Where it was sold
Why it was recalled
Stop using this product now
The distal end of the core wire of the TorqVue FX Delivery System could potentially fracture when exposed to a combination of certain cardiac anatomies and usage conditions.
Using this product could cause serious injury, illness or death — stop using it now.
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