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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "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."
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…
- Manufacturer
- St Jude Medical Inc
- 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
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