St. Jude Medical Recalls Proclaim 7 Elite Implantable Pulse Generators
St. Jude Medical is recalling 9,529 Proclaim 7 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. The hazard involves the loss of therapeutic function (neuromodulation) due to exposure to external medical devices, which poses a significant risk of harm to patients, but the source does not report specific injuries or fatalities.
Plain-English summary
St. Jude Medical, Inc. is recalling 9,529 units of the Proclaim 7 Elite Implantable Pulse Generator (IPG), reference number 3662. The device is an electronic implant designed to deliver constant-current electrical stimulation to one or more anatomical areas via connected leads and electrodes.
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. The affected units were distributed nationwide in the United States.
Patients with these specific devices should contact their healthcare provider to discuss the potential risk and appropriate management strategies. The recall covers specific serial codes listed in the official FDA documentation.
The recalled product
- Product
- Proclaim 7 Elite, Implantable Pulse Generator, REF 3662, 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
- 9,529
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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