Z-2287-2025Class II

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...

Name: 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...
Creator: Spark Biomedical Inc
Published: 2025-07-02
License: https://open.fda.gov/license/

Spark Biomedical Inc. / initiated 2025-07-02 / Open, Classified / root cause: manufacturing process

FDA source

Spark Biomedical Inc began a recall of 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 on 2025-07-02. FDA classified it as Class II and gives the reason as "Due to manufacturing issue, neurostimulator device may experience "cable disconnect" error message and interruption to stimulation output". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2287-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-07-02
Posted: 2025-08-11
Recalling firm: Spark Biomedical Inc.
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
Product code: PZR Percutaneous Nerve Stimulator For Opioid Withdrawal
Reason for recall: Due to manufacturing issue, neurostimulator device may experience "cable disconnect" error message and interruption to stimulation output.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 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 commerce: 78 units
Distribution: US Nationwide distribution.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2287-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2287-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-08-20	2025-08-11

Product code PZR

K230796Class IISparrow AscentSpark Biomedical, Inc. / cleared 2023-06-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)