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.

1 linked reportMalfunction 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	0	2
2019-05	0	1
2019-09	0	1
2019-10	0	1
2019-11	0	1
2019-12	0	3
2020-02	0	2
2020-03	0	1
2020-04	0	1
2020-06	0	1
2020-07	0	1
2020-11	0	1
2021-02	0	2
2021-03	0	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	0	1.5
2021-10	0	1.5
2021-11	0	4
2021-12	0	5.5
2022-01	0	4
2022-02	0	4.33
2022-03	0	1.5
2022-04	0	2.75
2022-05	0	2
2022-06	0	3.67
2022-07	0	2.25
2022-08	0	2.2
2022-09	0	2.2
2022-10	0	3.25
2022-11	0	3.67
2022-12	0	2
2023-01	0	2.25
2023-02	0	2.4
2023-03	0	6.6
2023-04	0	8
2023-05	0	8
2023-06	0	13.25
2023-07	0	7.2
2023-08	0	8.67
2023-09	0	6.75
2023-10	0	5
2023-11	0	8.5
2023-12	0	5
2024-01	0	9
2024-02	0	2.33
2024-03	0	7.6
2024-04	1	4.5
2024-05	0	5.13
2024-06	0	6.11
2024-07	0	7.17
2024-08	0	6.13
2024-09	0	5.14
2024-10	0	5
2024-11	0	14.89
2024-12	0	7.33
2025-01	0	12
2025-02	0	9.85
2025-03	0	9.55
2025-04	0	9.44
2025-05	0	8
2025-06	0	11.38
2025-07	0	10.25
2025-08	0	7.75
2025-09	0	9.67
2025-10	0	7.7
2025-11	0	12.82
2025-12	0	20
2026-01	0	9.92
2026-02	0	18.33
2026-03	0	19.1
2026-04	0	13.36
2026-05	0	14.08
2026-06	0	16.11

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

Failure-mode summaryAI-generated

1 linked report narrative available — no AI summary generated yet.

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2024-04-12	3007420694-2024-00102	Malfunction	Available	exact di

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

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