St Jude Medical recalls Proclaim 7 Elite implantable pulse generators (IPG) with REF 3662 that may lose neuromodulation therapy if exposed to monopolar electrosurgical devices during medical procedures.
The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monopolar electrosurgical devices (ESU) during medical procedures.
St. Jude Medical is recalling Proclaim 7 Elite implantable pulse generators (IPG) with REF 3662. These devices may lose neuromodulation therapy if exposed to monopolar electrosurgical devices (ESU) during medical procedures. This recall affects patients with implanted pulse generators used for neuromodulation therapy.
The IPG can lose its neuromodulation therapy if exposed to monopolar electrosurgical devices (ESU) during medical procedures. This means the device may stop working properly when it comes into contact with certain surgical tools used in procedures.
Patients with Proclaim 7 Elite implantable pulse generators (IPG) REF 3662 that are used for neuromodulation therapy. Medical professionals performing procedures with monopolar electrosurgical devices may also be affected.
Look for the Proclaim 7 Elite implantable pulse generator (IPG) with REF 3662. This device is used for neuromodulation therapy and is implanted under the skin. It is designed to be connected to leads with up to 16 electrodes.
Verify if your Proclaim 7 Elite IPG has REF 3662 and is used for neuromodulation therapy.
Reach out to St. Jude Medical for guidance on whether your device needs repair or replacement.
The device may lose neuromodulation therapy if exposed to monopolar electrosurgical devices during medical procedures.
No, but you should contact St. Jude Medical to determine if your device needs repair or replacement.
Look for the Proclaim 7 Elite implantable pulse generator (IPG) with REF 3662 used for neuromodulation therapy.
We’ve drafted a message you can send St Jude Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2692-2017 — St Jude Medical St Jude Medical Hello, I own a St Jude Medical that is covered by recall Z-2692-2017 from St Jude Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
