AxiEM™ · 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.

35 linked reportsMalfunction 35

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	2.75
2019-02	0	3
2019-03	0	4.67
2019-04	3	2.44
2019-05	0	22
2019-06	1	4.25
2019-07	0	6
2019-08	0	7
2019-09	0	2.2
2019-10	1	1.75
2019-11	0	1.25
2019-12	0	5
2020-01	0	1.5
2020-02	1	2.4
2020-03	0	6
2020-04	0	1.5
2020-05	0	2
2020-06	1	2.4
2020-07	0	3
2020-08	0	5
2020-09	0	1.33
2020-10	0	6
2020-11	1	1.5
2020-12	0	5
2021-01	0	3
2021-02	0	4.5
2021-03	0	8
2021-04	0	5.33
2021-05	0	10.5
2021-06	1	5
2021-07	0	6.67
2021-08	0	5.6
2021-09	1	3.2
2021-10	0	3
2021-11	0	3
2021-12	0	3.67
2022-01	0	2.5
2022-02	0	3.75
2022-03	0	4.5
2022-04	0	3
2022-05	0	4.5
2022-06	0	2.89
2022-07	0	3.75
2022-08	0	3
2022-09	1	2.33
2022-10	0	5.5
2022-11	0	5.2
2022-12	0	2.25
2023-01	0	4.83
2023-02	1	2.67
2023-03	0	3.11
2023-04	0	3.5
2023-05	0	5.17
2023-06	0	3
2023-07	0	3.5
2023-08	0	3.8
2023-09	1	2.89
2023-10	0	2.5
2023-11	1	2.89
2023-12	0	4.11
2024-01	1	2
2024-02	0	3.25
2024-03	0	2.7
2024-04	0	4.09
2024-05	1	2.73
2024-06	0	2.33
2024-07	2	3
2024-08	0	6.67
2024-09	1	2
2024-10	2	4.6
2024-11	3	4.83
2024-12	2	3.8
2025-01	0	1.92
2025-02	5	4.65
2025-03	2	3.43
2025-04	1	1.93
2025-05	0	5.67
2025-06	0	8.5
2025-07	1	1.75
2025-08	0	4
2025-09	0	3
2025-10	0	2.4
2025-11	0	4.5
2025-12	0	2
2026-01	0	2.1
2026-02	0	2.33
2026-03	0	6.5
2026-04	0	1.38
2026-05	0	3
2026-06	0	2

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

Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2025-07-03	1723170-2025-02608	Malfunction	Available	model number
2025-04-04	1723170-2025-01564	Malfunction	Available	model number
2025-03-20	1723170-2025-01390	Malfunction	Available	model number
2025-03-10	1723170-2025-01236	Malfunction	Available	model number
2025-02-28	1723170-2025-01081	Malfunction	Available	model number
2025-02-21	1723170-2025-00872	Malfunction	Available	model number
2025-02-20	1723170-2025-00856	Malfunction	Available	model number
2025-02-20	1723170-2025-00845	Malfunction	Available	model number
2025-02-20	1723170-2025-00855	Malfunction	Available	model number
2024-12-13	1723170-2024-03930	Malfunction	Available	model number
2024-12-13	1723170-2024-03922	Malfunction	Available	model number
2024-11-13	20673920	Malfunction	Available	exact di
2024-11-05	1723170-2024-03429	Malfunction	Available	model number
2024-10-11	1723170-2024-03074	Malfunction	Available	model number
2024-10-11	1723170-2024-03089	Malfunction	Available	model number

Showing the most recent 34 of 35 linked reports.

Showing 1–15 of 34

Regulatory clearances

None linked.

Manufacturer compliance record

Date	Type	Outcome	Facility	Citations
2024-02-09	VAI	Voluntary action indicated	Medtronic Navigation, Inc.	3
2021-06-29	VAI	Voluntary action indicated	Medtronic Navigation, Inc.	3
2019-09-30	VAI	Voluntary action indicated	Medtronic Navigation, Inc.	1
2016-08-18	VAI	Voluntary action indicated	Medtronic Navigation, Inc.	0
2014-12-15	NAI	No action indicated	Medtronic Navigation, Inc.	0
2014-02-19	VAI	Voluntary action indicated	Medtronic Navigation, Inc.	5
2012-09-06	NAI	No action indicated	Medtronic Navigation, Inc.	0
2012-05-01	NAI	No action indicated	Medtronic Navigation, Inc.	0
2011-03-24	VAI	Voluntary action indicated	Medtronic Navigation, Inc.	1
2010-05-07	WL	Warning Letter	Medtronic Navigation, Inc.	—
2010-02-04	OAI	Official action indicated	Medtronic Navigation, Inc.	9

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