Battery Pack Used with the Capnostream"20 and Capnostream"20p Patient… — Class I medical device recall Z-1577-2016
Terminated recall by Medtronic, reported 2016-05-18, distributed nationwide. Medtronic Respiratory & Monitoring Solutions Announces a Voluntary Recall of a Battery Pack Used with the Capn
| Recall number | Z-1577-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic, Boulder, CO, United States |
| Recall initiated | 2016-04-13 |
| Classified | 2016-05-12 |
| Reported by FDA | 2016-05-18 |
| Terminated | 2017-10-17 |
| Distributed | Nationwide (US) |
| Model numbers | 010520, 016400 |
Product
Battery Pack Used with the Capnostream"20 and Capnostream"20p Patient Monitor, Battery Packs Model Number - 016400, 010520. Battery Pack used with the Capnostream"20 and Capnostream"20p Patient Monitor. The battery pack powers the monitor when AC power is not available or when monitoring is required during intra-hospital transfer of patients. The Capnostream"20 and Capnostream"20p is a combined capnograph/pulse oximeter monitor and its accessories are intended to provide professionally trained health care providers with continuous, non-invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate, and with continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It is intended for use with neonatal, pediatric, and adult patients in hospitals, hospital-type facilities, and intra-hospital transport environments
Reason for recall
Medtronic Respiratory & Monitoring Solutions Announces a Voluntary Recall of a Battery Pack Used with the Capnostream"20 and Capnostream"20p Patient Monitor Due to the Battery Pack Might Experience Thermal Runaway with the Potential of Fire Risk to the Monitor.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.