[Recalled] EMBLEM MRI S-ICD Model A219 — Electrical overstress may lead to device malfunction | FDA 2020-12-02
A safety authority has issued a recall or warning for this item. The confirmed facts from the source notice are laid out below.
Recall details
| Product | EMBLEM MRI S-ICD Model A219 |
|---|---|
| Brand / manufacturer | Boston Scientific Corporation |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0951-2021 |
| Country of notice | United States |
| Risk level | Class I |
| Hazard type | recall |
| Notice date | 02 December 2020 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Electrical overstress may lead to device malfunction.
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 →
Related recalls from Boston Scientific Corporation
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.