Recall Z-0763-2013— St Jude Medical Inc

Name: FDA recall Z-0763-2013
Creator: U.S. Food and Drug Administration
Published: 2013-01-18

Class I · Terminated

Class I FDA medical device recall by St Jude Medical Inc, initiated 2013-01-18, terminated 2013-05-21. It names one FDA 510(k) clearance: K121611. Product: 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.. Reason: 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..

Recalling firm: St Jude Medical Inc
Classification: Class I
Status: Terminated
Initiated: 2013-01-18
Terminated: 2013-05-21
Firm location: Saint Paul, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K121611 — AMPLATZER TORQVUE FXAga Medical Corporation·cleared 2012-08-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.