Spark Biomedical Inc: Medical Device Recall in 2025 - (Recall #: Z-2287-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: July 2, 2025

Date Posted: August 20, 2025

Recall Number: Z-2287-2025

Event ID: 97185

Reason for Recall:

Due to manufacturing issue, neurostimulator device may experience "cable disconnect" error message and interruption to stimulation output.

Status: Ongoing

Product Quantity: 78 units

Code Information:

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 Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated