AVANTI · 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.

6 linked reportsMalfunction 6

Monthly adverse-event reports for this device versus the product-code average.
Month	This device (reports)	Product-code average (reports per device)
2019-01	0	1
2019-02	0	1
2019-03	0	2.4
2019-04	0	2
2019-05	0	1.78
2019-06	0	1.5
2019-07	0	1.5
2019-08	0	1.45
2019-09	0	3
2019-10	0	1.33
2019-11	0	3.88
2019-12	0	1.33
2020-01	0	1.67
2020-02	0	1.86
2020-03	0	1.5
2020-04	0	1.75
2020-05	0	1.83
2020-06	0	4.75
2020-07	0	2.25
2020-08	0	1.33
2020-09	0	1.8
2020-10	0	1.6
2020-11	0	1.3
2020-12	0	1.8
2021-01	0	1.75
2021-02	0	1.5
2021-03	0	1.5
2021-04	0	2.17
2021-05	0	1.5
2021-06	6	3
2021-07	0	2.6
2021-08	0	3.33
2021-09	0	3
2021-10	0	1
2021-11	0	1.4
2021-12	0	1.86
2022-01	0	1.14
2022-02	0	1.45
2022-03	0	2.69
2022-04	0	1
2022-05	0	2.45
2022-06	0	1.67
2022-07	0	1.67
2022-08	0	1.67
2022-09	0	1.91
2022-10	0	1.4
2022-11	0	1.5
2022-12	0	1.78
2023-01	0	1.4
2023-02	0	1.67
2023-03	0	2.62
2023-04	0	1.91
2023-05	0	2.3
2023-06	0	2.55
2023-07	0	3.8
2023-08	0	2.95
2023-09	0	4.67
2023-10	0	2.17
2023-11	0	3.36
2023-12	0	3.32
2024-01	0	2.31
2024-02	0	3.25
2024-03	0	2.45
2024-04	0	2.29
2024-05	0	3.27
2024-06	0	3.14
2024-07	0	1.81
2024-08	0	2.18
2024-09	0	2.57
2024-10	0	2.26
2024-11	0	2.25
2024-12	0	1.86
2025-01	0	2.15
2025-02	0	3.63
2025-03	0	2.71
2025-04	0	1.84
2025-05	0	2.05
2025-06	0	2.7
2025-07	0	3.32
2025-08	0	2.62
2025-09	0	1.85
2025-10	0	3.06
2025-11	0	1.86
2025-12	0	2.14
2026-01	0	2.2
2026-02	0	2.24
2026-03	0	3.11
2026-04	0	2.44
2026-05	0	5.14
2026-06	0	2.31

This device (reports/month)Average device in DRE (reports/device/month)

Failure-mode summaryAI-generated

6 linked report narratives available — no AI summary generated yet.

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2021-06-10	9616099-2021-04626	Malfunction	Available	catalog number
2021-06-10	9616099-2021-04627	Malfunction	Available	catalog number

Showing the most recent 2 of 6 linked reports.

Regulatory clearances

None linked.

Manufacturer compliance record

Date	Type	Outcome	Facility	Citations
2022-06-29	VAI	Voluntary action indicated	Cordis US Corp	0
2022-06-29	VAI	Voluntary action indicated	Cordis US Corp	0
2018-01-12	VAI	Voluntary action indicated	Cordis US Corp	1
2018-01-12	VAI	Voluntary action indicated	Cordis US Corp	1
2017-09-15	VAI	Voluntary action indicated	AccessClosure, Inc., A Cardinal Health Company	1
2016-07-06	NAI	No action indicated	Cordis US Corp	0
2016-07-06	NAI	No action indicated	Cordis US Corp	0
2016-03-31	NAI	No action indicated	Cordis US Corp	0
2016-03-31	NAI	No action indicated	Cordis US Corp	0
2016-02-12	VAI	Voluntary action indicated	Cardinal Health Mexico 244 S de RL de CV	3
2016-02-01	NAI	No action indicated	AccessClosure, Inc., A Cardinal Health Company	0
2015-05-08	NAI	No action indicated	Cordis US Corp	0
2015-05-08	NAI	No action indicated	Cordis US Corp	0
2014-08-05	VAI	Voluntary action indicated	AccessClosure, Inc., A Cardinal Health Company	3
2014-04-03	NAI	No action indicated	Cardinal Health Mexico 244 S de RL de CV	0
2014-01-30	NAI	No action indicated	Cordis US Corp	0
2014-01-30	NAI	No action indicated	Cordis US Corp	0
2013-12-18	NAI	No action indicated	Cordis US Corp	0
2013-12-18	NAI	No action indicated	Cordis US Corp	0
2012-07-03	NAI	No action indicated	Cordis US Corp	0
2011-02-16	WL	Warning Letter	Cordis LLC	—

Similar devices