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[Recalled] EMBLEM MRI S-ICD Model A219 — Electrical overstress may lead to device malfunction | FDA 2020-12-02

recall fda device united-states

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

ProductEMBLEM MRI S-ICD Model A219
Brand / manufacturerBoston Scientific Corporation
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-0951-2021
Country of noticeUnited States
Risk levelClass I
Hazard typerecall
Notice date02 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.

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