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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
2025-10-28NAINo action indicatedMerz North America, Inc.0
2025-10-28NAINo action indicatedMerz North America, Inc.0
2024-01-03NAINo action indicatedMerz North America, Inc.0
2024-01-03NAINo action indicatedMerz North America, Inc.0
2023-06-22NAINo action indicatedMerz North America, Inc.0
2023-06-22NAINo action indicatedMerz North America, Inc.0
2018-07-26VAIVoluntary action indicatedMerz North America, Inc.2
2018-07-26VAIVoluntary action indicatedMerz North America, Inc.2
2015-03-31NAINo action indicatedMerz North America0
2014-09-02VAIVoluntary action indicatedMerz North America, Inc.0
2014-09-02VAIVoluntary action indicatedMerz North America, Inc.0
2014-08-15VAIVoluntary action indicatedMerz North America, Inc.1
2014-08-15VAIVoluntary action indicatedMerz North America, Inc.1
2013-04-19NAINo action indicatedMerz North America, Inc.0
2013-04-19NAINo action indicatedMerz North America, Inc.0
2013-04-19NAINo action indicatedMerz North America, Inc.0
2013-04-19NAINo action indicatedMerz North America, Inc.0
2012-07-31NAINo action indicatedMerz North America, Inc.0
2012-07-31NAINo action indicatedMerz North America, Inc.0
2011-07-21VAIVoluntary action indicatedMerz North America, Inc.0
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