The Recall Desk
HighFDA (Devices)·Z-0763-2013·Announced 2013-02-20

St. Jude Medical Recalls TorqVue FX Delivery Systems Due to Fracture Risk

St. Jude Medical is recalling 635 TorqVue FX Delivery Systems because the core wire could fracture during use.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a potential for fracture during use, which poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the criteria for a high-risk product where injury has not yet been reported.

Plain-English summary

St. Jude Medical is recalling 635 units of the AMPLATZER TorqVue FX Delivery System. These cardiac surgical instruments are used to close atrial septal defects between the right and left atriums. The recall covers specific model numbers, including 9-ITVFX06F45/60, 9-ITVFX07F45/60, and 9-ITVFX007F45/80, among others.

The recall was initiated because the distal end of the core wire in the delivery system could potentially fracture. This risk is associated with exposure to a combination of certain cardiac anatomies and usage conditions. The affected devices were distributed nationwide, including the District of Columbia and numerous states.

Healthcare providers and consumers should stop using the affected devices immediately. St. Jude Medical is the recalling firm responsible for managing the recall. No specific dates or lot numbers other than 'all batches' are provided in the source text.

The recalled product

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
Manufacturer
St Jude Medical Inc
Category
Medical Device — Cardiac Surgical Instrument
Hazard
Affected units
635

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • all batches

Distribution

Distributed nationwide across the United States.

The notice also names 40 states specifically:

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