Citadel · 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.

121 linked reportsMalfunction 107Injury 13Death 1

Monthly adverse-event reports for this device versus the product-code average.
Month	This device (reports)	Product-code average (reports per device)
2019-03	2	2
2019-05	1	1
2019-09	1	1
2019-10	0	1
2019-11	1	1
2019-12	3	3
2020-02	3	2
2020-03	1	1
2020-04	1	1
2020-06	1	1
2020-07	1	1
2020-11	1	1
2021-02	1	2
2021-03	1	1.33
2021-04	0	3.25
2021-05	0	2.33
2021-06	0	10
2021-07	0	3
2021-08	0	2
2021-09	1	1.5
2021-10	0	1.5
2021-11	0	4
2021-12	3	5.5
2022-01	3	4
2022-02	0	4.33
2022-03	0	1.5
2022-04	1	2.75
2022-05	0	2
2022-06	1	3.67
2022-07	2	2.25
2022-08	1	2.2
2022-09	1	2.2
2022-10	1	3.25
2022-11	2	3.67
2022-12	0	2
2023-01	1	2.25
2023-02	2	2.4
2023-03	2	6.6
2023-04	4	8
2023-05	1	8
2023-06	1	13.25
2023-07	4	7.2
2023-08	1	8.67
2023-09	0	6.75
2023-10	3	5
2023-11	2	8.5
2023-12	0	5
2024-01	1	9
2024-02	1	2.33
2024-03	2	7.6
2024-04	2	4.5
2024-05	1	5.13
2024-06	2	6.11
2024-07	4	7.17
2024-08	1	6.13
2024-09	3	5.14
2024-10	2	5
2024-11	1	14.89
2024-12	2	7.33
2025-01	3	12
2025-02	2	9.85
2025-03	5	9.55
2025-04	3	9.44
2025-05	3	8
2025-06	2	11.38
2025-07	3	10.25
2025-08	1	7.75
2025-09	0	9.67
2025-10	1	7.7
2025-11	4	12.82
2025-12	2	20
2026-01	2	9.92
2026-02	1	18.33
2026-03	3	19.1
2026-04	1	13.36
2026-05	3	14.08
2026-06	5	16.11

This device (reports/month)Average device in IOQ (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
2026-06-25	3007420694-2026-00108	Malfunction	—	exact di
2026-06-19	3007420694-2026-00110	Malfunction	Available	exact di
2026-06-03	3007420694-2026-00089	Malfunction	Available	exact di
2026-06-03	3007420694-2026-00095	Malfunction	Available	exact di
2026-06-03	3007420694-2026-00094	Malfunction	Available	exact di
2026-05-26	3007420694-2026-00086	Malfunction	Available	exact di
2026-05-12	3007420694-2026-00074	Malfunction	Available	exact di
2026-05-12	3007420694-2026-00082	Malfunction	Available	exact di
2026-04-17	3007420694-2026-00054	Malfunction	Available	exact di
2026-03-31	3007420694-2026-00051	Malfunction	Available	exact di
2026-03-31	3007420694-2026-00046	Malfunction	Available	exact di
2026-03-31	3007420694-2026-00045	Malfunction	Available	exact di
2026-02-04	3007420694-2026-00023	Malfunction	Available	exact di
2026-01-29	3007420694-2026-00015	Malfunction	Available	exact di
2026-01-23	3007420694-2026-00011	Malfunction	Available	exact di

Showing 1–15 of 121

Regulatory clearances

None linked.

Manufacturer compliance record

Date	Type	Outcome	Facility	Citations
2015-04-23	NAI	No action indicated	Arjo (Suzhou) Co., Ltd.	0
2014-03-20	VAI	Voluntary action indicated	ARJOHUNTLEIGH POLSKA Sp. z.o.o.	3
2013-02-07	NAI	No action indicated	ARJOHUNTLEIGH AB	0
2013-02-07	NAI	No action indicated	ARJOHUNTLEIGH AB	0
2012-09-06	VAI	Voluntary action indicated	Huntleigh Healthcare Ltd.	0
2011-11-24	NAI	No action indicated	Arjo (Suzhou) Co., Ltd.	0

Similar devices