[Recalled] PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231). — A subset of devices from the ACCOLADE Family of Pacemakers and CR
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 | PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231). |
|---|---|
| Brand / manufacturer | Boston Scientific Corporation |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0823-2025 |
| Country of notice | United States |
| Risk level | Class I |
| Hazard type | recall |
| Notice date | 12 December 2024 |
| EAN / barcode | 00802526559044 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery impedance.
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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