{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-04-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "country": "United States", "city": "Mounds View", "address_1": "8200 Coral Sea St Ne", "reason_for_recall": "There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of some device features (i.e., battery measurements, Capture Management\", Atrial Lead Position Check\", EffectivCRT\" algorithms, and AdaptivCRT\"). This rare interaction results in temporary suspension of automatic threshold testing and output adjustments, and suspension of auto-optimization of CRT therapy. The issue is unlikely to result in clinical impact to the patient, and features are restored upon next programmer device interrogation or presence of a magnet.", "address_2": "", "product_quantity": "1025 devices", "code_info": "serial numbers: RFA001342A RFA001412A RFA001748A RFA001760A RFA001802A RFA001845A RFA001868A RFA001885A RFA002011A RFA002039A RFA002152A RFA003642A RFA003644A RFA003652A RFA003658A RFA003669A RFA003671A RFA003673A RFA003677A RFA003684A RFA003690A RFA003691A RFA003692A RFA003703A RFA003704A RFA003705A RFA004075A RFA004079A RFA004082A RFA004208A RFA004218A RFA004232A RFA004277A RFA004386A RFA004390A RFA004391A RFA004681A RFA004706A RFA005006A RFA005009A RFA005011A RFA005023A RFA005025A RFA005028A RFA005029A RFA005049A RFA005079A RFA005081A RFA005093A RFA005095A RFA005097A RFA005103A RFA005105A RFA005125A RFA005249A RFA005989A RFA006832A RFA008087A RFA008119A RFA008908A RFA009323A RFA010721A RFA010722A RFA010895A RFA011167A RFA011196A RFA011348A RFA011359A 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"20200604", "postal_code": "55112-4391", "voluntary_mandated": "Voluntary: Firm initiated", "status": "Ongoing" } ] }