St. Jude Medical Recalls Infinity 5 Implantable Pulse Generators
St. Jude Medical is recalling 443 Infinity 5 Implantable Pulse Generators due to a risk of losing neuromodulation therapy when 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 is classified as FDA Class II and involves a risk of loss of therapy for an implanted medical device, which fits the rubric for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
St. Jude Medical, Inc. is recalling 443 units of the Infinity 5 Implantable Pulse Generator (IPG), Reference 6660. These devices are electronic medical devices 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 IPG is exposed to monopolar electrosurgical devices (ESU) during medical procedures. This exposure can interfere with the device's function, potentially causing the therapy to stop working.
Patients with these implanted devices should contact their healthcare provider to discuss the recall and determine if any action is necessary. The recall is classified as Class II by the FDA, indicating a reasonable probability that the device could cause temporary or medically reversible health consequences.
The recalled product
- Product
- Infinity 5, Implantable Pulse Generator, REF 6660, 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 c
- Manufacturer
- St. Jude Medical, Inc.
- Affected units
- 443
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.
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