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
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2020-11-03 | Z-0641-2021 | Class II | Terminated | Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedureDistribution: US Nationwide distribution including in the states of IL,NY, NJ, WI, MI, MN, WI. | 11,000 units | code info di |
Regulatory clearances
None linked.
Manufacturer compliance record
None in the loaded window.
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