[pending] Azure S DR MRI SureScan, Product number W3DR01
Pending LLM rewrite. Source: FDA_DEVICE Z-1924-2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Identified devices may experience sudden battery power failure without alarm, power supply power-on-resets, and interruption of therapy. Potential patient harms include insufficient pacing support leading to cardiac arrest, syncope, or hospitalization; or system revision (explant/replacement) leading to infection, hematoma, or temporary impairment.
The recalled product
- Product
- Azure S DR MRI SureScan, Product number W3DR01
- Manufacturer
- Medtronic, Inc.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Serial numbers RNJ108800G
- RNJ108808G
- serial numbers: RNJ108803G RNJ108804G RNJ108820G
Distribution
Distribution scope not specified by the agency.
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