Hemashield · 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.

30 linked reportsMalfunction 30

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	2
2019-03	0	3
2019-04	0	1.33
2019-05	0	1
2019-06	0	1
2019-07	0	3
2019-08	0	1.38
2019-10	0	2
2019-11	0	2.86
2019-12	0	2
2020-02	0	1
2020-04	0	3
2020-06	0	1.5
2020-07	0	1.5
2020-09	0	1
2020-10	0	2
2020-11	0	3.22
2020-12	0	4.5
2021-01	0	1
2021-02	0	2
2021-03	0	3
2021-05	0	36
2021-06	0	1
2021-07	0	2
2021-09	0	3
2021-11	0	2
2021-12	0	1.67
2022-01	0	1
2022-04	0	4
2022-05	0	2
2022-06	0	20
2022-07	0	2.5
2022-10	0	3
2022-11	0	6.33
2022-12	0	3
2023-01	0	2.67
2023-02	0	3
2023-03	0	12
2023-04	0	6.5
2023-05	0	12
2023-06	0	3
2023-07	0	1
2023-11	0	4.5
2023-12	0	2
2024-03	0	2
2024-04	0	1
2024-06	0	4
2024-08	0	10
2024-09	0	1
2024-10	27	27
2024-11	3	3
2024-12	0	1
2025-01	0	2
2025-05	0	1
2025-09	0	2
2025-10	0	6.67
2025-11	0	30.5
2026-03	0	1.5
2026-04	0	2
2026-06	0	2

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

Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2024-11-06	1640201-2024-0000027	Malfunction	Available	catalog number
2024-10-21	1640201-2024-0000018	Malfunction	Available	catalog number
2024-10-21	1640201-2024-0000017	Malfunction	Available	catalog number
2024-10-21	1640201-2024-0000016	Malfunction	Available	catalog number
2024-10-21	1640201-2024-0000024	Malfunction	Available	catalog number
2024-10-21	1640201-2024-0000020	Malfunction	Available	catalog number
2024-10-21	1640201-2024-0000021	Malfunction	Available	catalog number
2024-10-21	1640201-2024-0000023	Malfunction	Available	catalog number
2024-10-21	1640201-2024-0000022	Malfunction	Available	catalog number
2024-10-21	1640201-2024-0000019	Malfunction	Available	catalog number

Showing the most recent 10 of 30 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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