The Recall Desk
HighFDA (Devices)·Z-1577-2016·Announced 2016-05-18

Medtronic Recalls Capnostream 20 Patient Monitor Battery Packs

Medtronic is voluntarily recalling battery packs for the Capnostream 20 and 20p patient monitors because they may experience thermal runaway, posing a potential fire risk.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (fire risk) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.

Plain-English summary

Medtronic Respiratory & Monitoring Solutions is conducting a voluntary recall of battery packs used with the Capnostream 20 and Capnostream 20p patient monitors. The affected battery packs, identified by product numbers 016400 and 010520, may experience thermal runaway, which creates a potential fire risk to the monitor.

The recall involves 9,817 battery units, including 8,170 units shipped with monitors and 1,647 spare parts. These products were distributed nationwide to 49 states and the District of Columbia, as well as to customers worldwide. The Capnostream 20 and 20p monitors are intended for use by professionally trained healthcare providers to monitor patients in hospitals and transport environments.

Healthcare facilities and consumers should stop using the affected battery packs immediately. Medtronic is the recalling firm and is responsible for managing the recall process.

The recalled product

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 m
Manufacturer
Medtronic

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • Product # 016400
  • All SNs
  • irrespective of production date. Product # 010520
  • All SNs with production date starting 14.14

Distribution

Distributed nationwide across the United States.

The notice also names 50 states specifically: