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# Safety Update on Maquet/Datascope Pumps
- URL: https://www.fdaweb.com/safety-update-on-maquet-datascope-pumps/
- Published: 2019-11-19T12:00:00.000Z
- Updated: 2026-09-14T15:53:32.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5145545

An FDA device safety update about intra-aortic balloon pumps by Getinge’s Maquet/Datascope shutting down while running on battery power says the agency has received dozens more reports since an 11/2018 alert was issued. The malfunction can lead to the pumps’ stoppage and loss of hemodynamic support, a new [Medwatch notice](http://s2027422842.t.en25.com/e/es?s=2027422842&e=277423&elqTrackId=376c7bc788024cd5a73d955f2e3dcbdc&elq=edf3d652c96742fb9c7018d79a44eee7&elqaid=10342&elqat=1&ref=fdaweb.com) says.  

Since the first alert, FDA says it has received over 60 additional medical device reports related to this issue, including two patient deaths and one serious patient injury. “Although the deaths cannot be definitively attributed to the device shutting down, these devices are used on critically-ill patients in health care facilities, including during transport, and any interruption in treatment can result in serious patient harm or death,” the agency says.

FDA also recommends that facilities who use the devices to review the firm’s notice regarding the recall, review the newly developed [quick reference guides](http://s2027422842.t.en25.com/e/er?utm%5Fcampaign=FDA%20MedWatch%20Update%3A%20Intra-Aortic%20Balloon%20Pumps%20by%20Getinge%27s%20Maquet%2FDatascope&utm%5Fmedium=email&utm%5Fsource=Eloqua&s=2027422842&lid=10717&elqTrackId=A92E6D415E3A5BA46CDA276CC44701B2&elq=edf3d652c96742fb9c7018d79a44eee7&elqaid=10342&elqat=1), and schedule a training visit as soon as possible.