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Sparrow Ascent

Spark Biomedical Inc. · Model 313 · UDI-DI 00850052017552

PZR Prescription
8
510(k) clearances
0
Adverse events
1
Recalls
6
Facilities

Description

Sparrow Ascent Kit - B2C (Mastoid Left 7)

Recalls

DateFirmReason
2025-07-02Spark Biomedical IncDue to manufacturing issue, neurostimulator device may experience "cable disconnect" error message and interruption to stimulation output.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.