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U.S. Department of Health and Human Services

Class 2 Device Recall Sparrow Ascent Patient Controller

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 Class 2 Device Recall Sparrow Ascent Patient Controllersee related information
Date Initiated by FirmJuly 02, 2025
Date PostedAugust 11, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2287-2025
Recall Event ID 97185
510(K)NumberK230796 
Product Classification Percutaneous nerve stimulator for opioid withdrawal - Product Code PZR
ProductSparrow 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
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
Recalling Firm/
Manufacturer		 Spark Biomedical Inc
19830 Fm 1093 Rd Ste 401
Richmond TX 77407-8621
Manufacturer Reason
for Recall		Due to manufacturing issue, neurostimulator device may experience "cable disconnect" error message and interruption to stimulation output.
FDA Determined
Cause 2		Process control
ActionOn July 2, 2025, Spark Biomedical initiated a Urgent Medical Device Recall via phone. During the phone conversation, Spark Biomedical will ask consignees to take the following actions: 1. Spark Biomedical will replace all affected00 units at no cost. Even if the units appear to be working. 2. Current devices may continue to be used until they are replaced. 3. Please perform a check of the cable to patient controller connection before use. If this connection is loose or moves, please discontinue use of that patient controller device and quarantine that device until the replacement arrives. 4. Please notify all appropriate personnel at your facility that need to know about this recall.
Quantity in Commerce78 units
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = PZR
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