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.

11 linked reportsMalfunction 11

Monthly adverse-event reports for this device versus the product-code average.
Month	This device (reports)	Product-code average (reports per device)
2019-01	1	2.75
2019-02	0	3
2019-03	0	4.67
2019-04	0	2.44
2019-05	0	22
2019-06	2	4.25
2019-07	0	6
2019-08	0	7
2019-09	2	2.2
2019-10	0	1.75
2019-11	0	1.25
2019-12	0	5
2020-01	0	1.5
2020-02	0	2.4
2020-03	0	6
2020-04	0	1.5
2020-05	0	2
2020-06	0	2.4
2020-07	0	3
2020-08	0	5
2020-09	0	1.33
2020-10	0	6
2020-11	0	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	0	5
2021-07	0	6.67
2021-08	0	5.6
2021-09	0	3.2
2021-10	0	3
2021-11	0	3
2021-12	0	3.67
2022-01	2	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	0	2.33
2022-10	0	5.5
2022-11	0	5.2
2022-12	0	2.25
2023-01	0	4.83
2023-02	0	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	0	2.89
2023-10	0	2.5
2023-11	0	2.89
2023-12	0	4.11
2024-01	0	2
2024-02	0	3.25
2024-03	0	2.7
2024-04	0	4.09
2024-05	0	2.73
2024-06	1	2.33
2024-07	0	3
2024-08	0	6.67
2024-09	1	2
2024-10	0	4.6
2024-11	0	4.83
2024-12	0	3.8
2025-01	1	1.92
2025-02	0	4.65
2025-03	0	3.43
2025-04	0	1.93
2025-05	0	5.67
2025-06	0	8.5
2025-07	0	1.75
2025-08	0	4
2025-09	0	3
2025-10	0	2.4
2025-11	0	4.5
2025-12	1	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

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

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2025-12-19	1723170-2025-03948	Malfunction	Available	model number
2025-01-24	1723170-2025-00303	Malfunction	Available	model number
2024-09-26	1723170-2024-02844	Malfunction	Available	model number
2024-06-27	1723170-2024-01585	Malfunction	Available	model number
2022-01-19	1723170-2022-00080	Malfunction	Available	model number
2022-01-05	1723170-2022-00008	Malfunction	Available	model number
2019-09-26	1723170-2019-05029	Malfunction	Available	model number
2019-09-26	1723170-2019-05028	Malfunction	Available	model number
2019-06-11	1723170-2019-03174	Malfunction	Available	model number
2019-06-11	1723170-2019-03172	Malfunction	Available	model number
2019-01-22	1723170-2019-00366	Malfunction	Available	model number

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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