St. Jude Medical Recalls Infinity 5 Implantable Pulse Generators
St. Jude Medical is recalling 54 Infinity 5 Implantable Pulse Generators due to a risk of therapy loss if exposed to monopolar electrosurgical devices.
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 risk of harm (loss of therapy) for a medical device where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
St. Jude Medical, Inc. is recalling 54 units of the Infinity 5 Implantable Pulse Generator (REF 6661). The recall covers devices distributed nationwide in the United States.
The firm identified 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 management. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Infinity 5, Implantable Pulse Generator, REF 6661, 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
- 54
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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