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
Summary
The FDA issued a Class II for Sparrow Ascent Patient Controller, REF's: 11-110-K, 11-310-K, 11-320-K, 11-321-K by Spark Biomedical Inc. Reason: Due to manufacturing issue, neurostimulator device may experience "cable disconnect" error message and interruption to stimulation output..
Details
Source
Device Recall
External ID
Z-2287-2025
Action Date
2025-08-20
Status
Ongoing
Category
device
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
Lot/Code Info: 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
Quantity Affected: 78 units
Reason for Recall
Due to manufacturing issue, neurostimulator device may experience "cable disconnect" error message and interruption to stimulation output.
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-07-02
Company
Richmond, TX
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 169 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Spark Biomedical Inc has 3 FDA actions in our database, including 1 recall and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Spark Biomedical Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Spark Biomedical Inc have FDA actions?
Spark Biomedical Inc has 3 FDA actions in our database, including 1 recall and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2287-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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