CLASS II ONGOING Device recall · Reported 20 Aug 2025 · FDA Enforcement Report
Sparrow Ascent Patient Controller recalled by Spark Biomedical
Spark Biomedical is recalling Sparrow Ascent Patient Controller, distributed nationwide in the US. The recall was initiated on 2 Jul 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2287-2025
- FDA event ID
- 97185
- Recalling firm
- Spark Biomedical, Richmond, TX
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 2 Jul 2025
- FDA classified
- 11 Aug 2025
- Reported
- 20 Aug 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 2 Jul 2025 | Recall initiated by company | |
| 11 Aug 2025 | Classified by FDA | +40 days |
| 20 Aug 2025 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to manufacturing issue, neurostimulator device may experience "cable disconnect" error message and interruption to stimulation output.
Product as listed by the FDA
Sparrow Ascent Patient Controller, REF's: 11-110-K, 11-310-K, 11-320-K, 11-321-K, 11-310-K-28, 11-320-K-28, 11-321-K-28
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
Due to manufacturing issue, neurostimulator device may experience "cable disconnect" error message and interruption to stimulation output.
Which lots are affected?
Lot numbers: V2408xxxx and runs through V2519xxxx UDI: 11-110/00850052017033; 11-310-K/00860005396948; 11-320-K/00860005396986; 11-321-K/00850052017163; 11-310-K-28/00850052017088; 11-320-K-28/00850052017071; 11-321-K-28/00850052017170
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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