FDA Medical devices recall ·
Sparrow Ascent Patient Controller recall
- Recall number
- Z-2287-2025
- Date
- (initiated July 2, 2025)
- Company / brand
- Spark Biomedical Inc
19830 Fm 1093 Rd Ste 401, Richmond, TX, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 78 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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
Why was it recalled?
Due to manufacturing issue, neurostimulator device may experience "cable disconnect" error message and interruption to stimulation output.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
Distribution
US Nationwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2287-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.