[Recalled] Proclaim Plus 5 Implantable Pulse Generator REF 3670 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes tota
This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.
Recall details
| Product | Proclaim Plus 5 Implantable Pulse Generator REF 3670 Product Description: The 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 hermetically sealed battery within a titanium cas |
|---|---|
| Brand / manufacturer | Abbott Medical |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-2507-2023 |
| Country of notice | United States |
| Risk level | Class I |
| Hazard type | recall |
| Notice date | 18 July 2023 |
| EAN / barcode | 05415067046383 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).
This Class I recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Stop using the product immediately and follow the authority's remedy (return, repair, or disposal).
Read the full official notice →
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This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.