Spark Biomedical Inc: 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

Hazard

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

Details from the source

Reason for recall: Due to manufacturing issue, neurostimulator device may experience "cable disconnect" error message and interruption to stimulation output. Distribution: US Nationwide distribution. Quantity: 78 units 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

UPC codes

00850052017033, 00860005396948, 00860005396986, 00850052017163, 00850052017088, 00850052017071, 00850052017170

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.