SCANLAN® · 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 reportsDeath 3Malfunction 3

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	2.6
2019-02	0	4.67
2019-03	0	6.25
2019-04	0	6.57
2019-05	0	3.38
2019-06	0	3.64
2019-07	0	6.88
2019-08	0	5.29
2019-09	0	3.67
2019-10	0	3.88
2019-11	0	4.67
2019-12	0	6.5
2020-01	0	6
2020-02	0	5.14
2020-03	0	6
2020-04	0	5.2
2020-05	0	3.29
2020-06	0	8
2020-07	0	5.89
2020-08	0	12.6
2020-09	0	6.71
2020-10	0	7.14
2020-11	0	9.14
2020-12	0	7.38
2021-01	0	3.25
2021-02	0	7
2021-03	0	6.44
2021-04	0	6.29
2021-05	0	3.8
2021-06	0	7.7
2021-07	0	7.5
2021-08	0	7
2021-09	0	2.57
2021-10	0	7.2
2021-11	0	14.6
2021-12	0	6.75
2022-01	0	5.78
2022-02	0	8.6
2022-03	0	4
2022-04	0	3.6
2022-05	0	6.8
2022-06	0	9
2022-07	0	3.25
2022-08	0	3
2022-09	0	5.75
2022-10	0	2.4
2022-11	0	6.8
2022-12	0	5.2
2023-01	0	9.5
2023-02	0	20.83
2023-03	0	14.86
2023-04	0	12.29
2023-05	0	19.6
2023-06	0	35.88
2023-07	0	25.71
2023-08	0	9.36
2023-09	0	8.5
2023-10	0	7
2023-11	0	8.42
2023-12	0	14.86
2024-01	0	9
2024-02	0	9.83
2024-03	3	12.13
2024-04	0	11
2024-05	0	14.63
2024-06	3	15.25
2024-07	0	15.25
2024-08	0	21
2024-09	0	16
2024-10	0	12
2024-11	0	17.43
2024-12	0	12.33
2025-01	0	10.5
2025-02	0	16.5
2025-03	0	10.7
2025-04	0	10.5
2025-05	0	10.6
2025-06	0	21.71
2025-07	0	13.92
2025-08	0	8.56
2025-09	0	12.86
2025-10	0	10
2025-11	0	9.38
2025-12	0	6.46
2026-01	0	8.5
2026-02	0	4
2026-03	0	16
2026-04	0	17.09
2026-05	0	8.71
2026-06	0	15.71

This device (reports/month)Average device in DXC (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
2024-06-11	2126670-2024-00005	Malfunction	Available	catalog number
2024-03-22	2126670-2024-00001	Death	Available	catalog number

Showing the most recent 2 of 6 linked reports.

Regulatory clearances

None linked.

Manufacturer compliance record

Date	Type	Outcome	Facility
2019-08-15	NAI	No action indicated	Scanlan International, Inc.
2019-08-15	NAI	No action indicated	Scanlan International, Inc.
2016-02-03	NAI	No action indicated	Scanlan International, Inc.
2016-02-03	NAI	No action indicated	Scanlan International, Inc.
2012-10-17	NAI	No action indicated	Scanlan International, Inc.
2012-10-17	NAI	No action indicated	Scanlan International, Inc.
2010-06-22	NAI	No action indicated	Scanlan International, Inc.
2010-06-22	NAI	No action indicated	Scanlan International, Inc.

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