Acrobat · recalls, adverse events, clearances

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

Date	Type	Outcome	Facility	Citations
2025-06-04	VAI	Voluntary action indicated	Cook Incorporated	6
2025-06-04	VAI	Voluntary action indicated	Cook Incorporated	6
2024-05-08	VAI	Voluntary action indicated	Cook Incorporated	1
2024-05-08	VAI	Voluntary action indicated	Cook Incorporated	1
2021-09-14	VAI	Voluntary action indicated	Cook Incorporated	2
2021-09-14	VAI	Voluntary action indicated	Cook Incorporated	2
2020-02-07	VAI	Voluntary action indicated	Cook Incorporated	4
2020-02-07	VAI	Voluntary action indicated	Cook Incorporated	4
2018-06-14	VAI	Voluntary action indicated	Cook Incorporated	1
2018-06-14	VAI	Voluntary action indicated	Cook Incorporated	1
2017-05-26	VAI	Voluntary action indicated	Cook Incorporated	3
2017-05-26	VAI	Voluntary action indicated	Cook Incorporated	3
2017-01-26	VAI	Voluntary action indicated	Cook Incorporated	11
2017-01-26	VAI	Voluntary action indicated	Cook Incorporated	11
2016-06-17	VAI	Voluntary action indicated	Cook Inc	2
2016-06-17	VAI	Voluntary action indicated	Cook Inc	2
2016-03-31	NAI	No action indicated	Cook Inc	0
2016-03-31	NAI	No action indicated	Cook Inc	0
2015-03-13	VAI	Voluntary action indicated	Cook Incorporated	5
2015-03-13	VAI	Voluntary action indicated	Cook Incorporated	5
2014-09-16	WL	Warning Letter	Cook Incorporated	—
2014-09-16	WL	Warning Letter	Cook Incorporated	—

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