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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
InitiatedRecall #ClassStatusReasonQuantityLink basis
2013-05-15Z-1682-2013Class IITerminatedA firm's internal investigation led to the discovery of pinholes in the packaging of the products. The pinholes are not likely to be detected by the end user prior to use and could compromise the sterile barrier properties of the packaging.Distribution: US Nationwide Distribution356,728 unitsclearance family
2013-05-15Z-1683-2013Class IITerminatedA firm's internal investigation led to the discovery of pinholes in the packaging of the products. The pinholes are not likely to be detected by the end user prior to use and could compromise the sterile barrier properties of the packaging.Distribution: US Nationwide Distribution530,488 unitsclearance family
2013-05-15Z-1684-2013Class IITerminatedA firm's internal investigation led to the discovery of pinholes in the packaging of the products. The pinholes are not likely to be detected by the end user prior to use and could compromise the sterile barrier properties of the packaging.Distribution: US Nationwide Distribution249,576 unitsclearance family
Regulatory clearances

None linked.

Manufacturer compliance record

None in the loaded window.

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