AIRSEAL · 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	2.2
2019-02	0	1
2019-03	0	2.3
2019-04	0	4.78
2019-05	0	1.3
2019-06	0	2
2019-07	0	5
2019-08	0	2.4
2019-09	0	6.5
2019-10	0	1.8
2019-11	0	1
2019-12	0	2
2020-01	0	1.71
2020-02	0	1.8
2020-03	0	3.5
2020-04	0	4.8
2020-05	0	3.5
2020-06	0	4.83
2020-07	0	9.57
2020-08	0	7.17
2020-09	0	7.86
2020-10	0	10.5
2020-11	0	8.8
2020-12	0	11.75
2021-01	0	14.63
2021-02	0	13.2
2021-03	0	11.17
2021-04	0	17.5
2021-05	0	9.75
2021-06	0	9.71
2021-07	0	12
2021-08	0	14.86
2021-09	0	13.13
2021-10	0	13.22
2021-11	0	20.29
2021-12	0	33.75
2022-01	0	12.42
2022-02	0	15.43
2022-03	0	18.86
2022-04	0	22
2022-05	0	20
2022-06	0	14.63
2022-07	0	11.75
2022-08	0	13.8
2022-09	2	9.33
2022-10	0	8.33
2022-11	0	11
2022-12	0	10.25
2023-01	0	7
2023-02	2	8.83
2023-03	0	32
2023-04	0	8.83
2023-05	0	5.56
2023-06	0	18
2023-07	0	16.25
2023-08	0	7.18
2023-09	0	8.86
2023-10	0	8.78
2023-11	0	9.5
2023-12	0	13.14
2024-01	0	23.25
2024-02	0	9.83
2024-03	0	6.29
2024-04	0	5.83
2024-05	0	12.5
2024-06	0	17.17
2024-07	0	21.5
2024-08	0	24
2024-09	0	26.8
2024-10	0	28.83
2024-11	0	10
2024-12	0	7.8
2025-01	0	4.43
2025-02	2	4.8
2025-03	0	2.83
2025-04	0	2.17
2025-05	0	1.78
2025-06	0	1.78
2025-07	0	2.63
2025-08	0	10.5
2025-09	0	3.4
2025-10	0	4.1
2025-11	0	7.2
2025-12	0	3.5
2026-01	0	1.77
2026-02	0	4
2026-03	0	5.11
2026-04	0	2.33
2026-05	0	2.46
2026-06	0	2.57

This device (reports/month)Average device in HIF (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
2025-02-19	21411912	Malfunction	Available	catalog number
2023-02-07	16310811	Malfunction	Available	model number
2023-02-07	16310812	Malfunction	Available	model number
2022-09-30	15515326	Malfunction	Available	catalog number

Showing the most recent 4 of 6 linked reports.

Regulatory clearances

None linked.

Manufacturer compliance record

Date	Type	Outcome	Facility	Citations
2026-05-13	NAI	No action indicated	Biorez, Inc	0
2026-04-06	VAI	Voluntary action indicated	ConMed Corporation	6
2026-04-06	VAI	Voluntary action indicated	ConMed Corporation	6
2023-12-14	NAI	No action indicated	Linvatec Corp.	0
2023-08-04	VAI	Voluntary action indicated	Biorez, Inc	1
2022-11-10	NAI	No action indicated	ConMed Corporation	0
2022-11-10	NAI	No action indicated	ConMed Corporation	0
2022-07-13	NAI	No action indicated	ConMed Corporation	0
2022-07-13	NAI	No action indicated	ConMed Corporation	0
2020-09-22	VAI	Voluntary action indicated	ConMed Corporation	0
2020-09-22	VAI	Voluntary action indicated	ConMed Corporation	0
2019-10-17	NAI	No action indicated	ConMed Corporation	0
2019-10-17	NAI	No action indicated	ConMed Corporation	0
2017-02-03	VAI	Voluntary action indicated	ConMed Corporation	2
2017-02-03	VAI	Voluntary action indicated	ConMed Corporation	2
2017-01-23	NAI	No action indicated	Conmed	0
2016-02-03	VAI	Voluntary action indicated	ConMed Corporation	5
2016-02-03	VAI	Voluntary action indicated	ConMed Corporation	5
2014-11-18	NAI	No action indicated	ConMed Corporation	0
2014-11-18	NAI	No action indicated	ConMed Corporation	0
2014-01-29	WL	Warning Letter	ConMed Corporation	—
2014-01-29	WL	Warning Letter	ConMed Corporation	—

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