St. Jude Medical, Inc. recalls Proclaim DRG Implantable Pulse Generator, Model Number 3664
- Recall date
- March 9, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1170-2018
- FDA classification
- Class II
- Brand / firm
- St. Jude Medical, Inc.
- Sold / distributed
- US
Why it was recalled
The firm received complaints of error messages that occurred during routine impedance checks on Proclaim DRG IPGs, model 3664. Some complaints were also associated with transient over stimulation which created discomfort for the patients.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Proclaim DRG Implantable Pulse Generator, Model Number 3664
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