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Adverse-event reports (MAUDE)

Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

No adverse-event reports are linked to this device.

Recall history

No recalls linked.

Regulatory clearances

None linked.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2023-03-30VAIVoluntary action indicatedInvacare Corporation2
2023-03-30NAINo action indicatedInvacare Corporation0
2023-03-30NAINo action indicatedInvacare Corporation0
2021-11-18WLWarning LetterInvacare Corporation—
2021-06-24OAIOfficial action indicatedInvacare Corporation0
2021-06-24OAIOfficial action indicatedInvacare Corporation6
2021-06-24OAIOfficial action indicatedInvacare Corporation0
2020-01-31VAIVoluntary action indicatedInvacare Corporation3
2020-01-31VAIVoluntary action indicatedInvacare Corporation0
2020-01-31VAIVoluntary action indicatedInvacare Corporation0
2019-03-08VAIVoluntary action indicatedInvacare Corporation0
2019-03-08VAIVoluntary action indicatedInvacare Corporation0
2019-03-08VAIVoluntary action indicatedInvacare Corporation0
2017-11-27VAIVoluntary action indicatedInvacare Corporation4
2017-11-07VAIVoluntary action indicatedInvacare Corporation2
2017-10-26NAINo action indicatedInvacare Corporation0
2017-06-16VAIVoluntary action indicatedInvacare Corporation1
2017-06-16VAIVoluntary action indicatedInvacare Corporation0
2017-06-07NAINo action indicatedInvacare Corporation0
2015-12-09OAIOfficial action indicatedInvacare Corporation0
2015-12-09OAIOfficial action indicatedInvacare Corporation8
2010-12-15WLWarning LetterInvacare Corporation—
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