St. Jude Medical Recalls Proclaim 5 Elite Implantable Pulse Generators
St. Jude Medical is recalling 8,780 Proclaim 5 Elite 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 the hazard involves a risk of harm (loss of therapy) for an implanted medical device where no specific injuries or illnesses have been reported in the source text.
Plain-English summary
St. Jude Medical, Inc. is recalling 8,780 units of the Proclaim 5 Elite implantable pulse generator (IPG), reference number 3660. The device is an electronic medical device designed to be connected to leads with up to 16 electrodes to deliver 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 it to stop delivering the intended therapy.
Patients with this specific implantable pulse generator should contact their healthcare provider to discuss the recall and determine if any action is necessary. The recall covers specific lot codes, which are listed in the official FDA recall documentation.
The recalled product
- Product
- Proclaim 5 Elite, implantable Pulse Generator, REF 3660, Rx only, STERILE EO Product Usage: The Proclaim implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a he
- Manufacturer
- St. Jude Medical, Inc.
- Affected units
- 8,780
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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