St. Jude Medical Recalls Infinity 7 Implantable Pulse Generators
St. Jude Medical is recalling 373 Infinity 7 Implantable Pulse Generators because exposure to monopolar electrosurgical devices may cause a loss of neuromodulation therapy.
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 is classified as FDA Class II. The hazard involves the loss of therapeutic function (neuromodulation) due to device exposure, which is a risk-of-harm scenario where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
St. Jude Medical, Inc. is recalling 373 units of the Infinity 7 Implantable Pulse Generator (REF 6662). These devices are electronic, battery-powered units designed to generate constant-current electrical stimulation for neuromodulation therapy. The affected units were distributed nationwide in the United States.
The recall was initiated because the firm discovered a risk of loss of neuromodulation therapy if the implanted device is exposed to monopolar electrosurgical devices (ESU) during medical procedures. The source text does not report any specific injuries, illnesses, or deaths associated with this defect.
Patients with these devices should contact their healthcare provider for guidance on monitoring and potential replacement. The recall number is Z-2695-2017.
The recalled product
- Product
- Infinity 7, Implantable Pulse Generator, REF 6662, Rx only, STERILE EO Product Usage: The Infinity IPG is an electronic device designed to be connected to one or two extensions. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic cir
- Manufacturer
- St. Jude Medical, Inc.
- Affected units
- 373
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by St. Jude Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
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