FDAFDA · Food and drugs·Recall number Z-2287-2025
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
Published August 20, 2025 · Recall initiated: July 2, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Due to manufacturing issue, neurostimulator device may experience "cable disconnect" error message and interruption to stimulation output.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Spark Biomedical Inc
- Distributor
- US Nationwide distribution.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.