Hemagard · 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.

45 linked reportsInjury 36Malfunction 9

Monthly adverse-event reports for this device versus the product-code average.
Month	This device (reports)	Product-code average (reports per device)
2019-01	3	2.43
2019-02	6	3.17
2019-03	0	2.38
2019-04	0	2.71
2019-05	3	2.2
2019-06	3	1.83
2019-07	0	2.06
2019-08	0	5.89
2019-09	0	2.27
2019-10	0	3.87
2019-11	0	3.75
2019-12	0	3.25
2020-01	0	3
2020-02	0	2.17
2020-03	0	3.43
2020-04	0	2.43
2020-05	0	4.29
2020-06	0	3
2020-07	0	2.67
2020-08	0	2.13
2020-09	0	2.25
2020-10	0	2.67
2020-11	0	2.69
2020-12	0	2.54
2021-01	0	2
2021-02	0	2.67
2021-03	0	2.13
2021-04	0	2.09
2021-05	0	2
2021-06	0	3.23
2021-07	0	4.67
2021-08	0	1.83
2021-09	0	3
2021-10	0	2.67
2021-11	0	2.13
2021-12	0	3.11
2022-01	0	2
2022-02	0	2.8
2022-03	0	4.14
2022-04	0	2.7
2022-05	0	2.5
2022-06	0	4.5
2022-07	0	1.88
2022-08	6	2.86
2022-09	0	2.4
2022-10	0	3
2022-11	0	4
2022-12	0	4
2023-01	0	2.5
2023-02	6	3.29
2023-03	0	4.5
2023-04	0	3.83
2023-05	0	3.5
2023-06	0	3.4
2023-07	0	4.36
2023-08	0	2.79
2023-09	0	3
2023-10	0	2.25
2023-11	0	2
2023-12	0	2.4
2024-01	0	5
2024-02	0	4.43
2024-03	0	2.38
2024-04	0	2
2024-05	0	2.17
2024-06	0	4
2024-07	0	2
2024-08	0	1.83
2024-09	0	1.5
2024-10	0	2
2024-11	0	1.5
2024-12	0	2.14
2025-01	0	2.36
2025-02	0	1
2025-03	0	2
2025-04	0	2.5
2025-05	0	3.71
2025-06	0	1.78
2025-07	0	4.57
2025-08	0	2
2025-09	0	1
2025-10	0	3
2025-11	0	2.75
2025-12	0	2.5
2026-01	0	1.5
2026-02	0	1.8
2026-03	18	3.35
2026-04	0	7.33
2026-05	0	3.44
2026-06	0	4.2

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

Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2026-03-16	2242352-2026-00004	Injury	Available	catalog number
2026-03-16	2242352-2026-00003	Injury	Available	catalog number
2026-03-16	2242352-2026-00005	Injury	Available	catalog number
2026-03-13	1640201-2026-0000006	Injury	Available	catalog number
2026-03-13	1640201-2026-0000005	Injury	Available	catalog number
2026-03-13	1640201-2026-0000004	Injury	Available	catalog number
2023-02-10	2242352-2023-00115	Injury	Available	catalog number
2023-02-07	1640201-2023-00004	Injury	Available	catalog number
2022-08-25	2242352-2022-00720	Injury	Available	catalog number
2022-08-18	1640201-2022-00025	Injury	Available	catalog number
2019-06-06	1640201-2019-00031	Malfunction	Available	catalog number
2019-05-24	1640201-2019-00029	Injury	Available	catalog number
2019-02-21	1640201-2019-00009	Malfunction	Available	catalog number
2019-02-21	1640201-2019-00010	Malfunction	Available	catalog number
2019-01-16	1640201-2019-00002	Injury	Available	catalog number

Showing the most recent 15 of 45 linked reports.

Regulatory clearances

None linked.

Manufacturer compliance record

Date	Type	Outcome	Facility	Citations
2019-09-19	VAI	Voluntary action indicated	INTERVASCULAR, SAS	3
2015-06-18	NAI	No action indicated	INTERVASCULAR, SAS	0

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