ACHIEVE · 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)
2019-01	0	10.56
2019-02	0	4.13
2019-03	0	2.6
2019-04	0	3.5
2019-05	0	7.38
2019-06	0	38.93
2019-07	0	8.98
2019-08	0	59.4
2019-09	0	30.31
2019-10	0	10.54
2019-11	0	33.61
2019-12	0	44.74
2020-01	0	39.04
2020-02	1	31.54
2020-03	0	137.06
2020-04	0	60.42
2020-05	0	33.55
2020-06	0	63.42
2020-07	0	57.25
2020-08	0	33.63
2020-09	0	40.24
2020-10	0	21.3
2020-11	0	28.13
2020-12	0	15.74
2021-01	0	19.26
2021-02	0	12.97
2021-03	0	12.7
2021-04	0	8.46
2021-05	0	4.29
2021-06	0	4.73
2021-07	0	5.77
2021-08	0	6.36
2021-09	0	10.65
2021-10	0	5.2
2021-11	0	4.17
2021-12	0	7.29
2022-01	0	6.9
2022-02	0	8.39
2022-03	0	5.48
2022-04	0	3.76
2022-05	0	3
2022-06	0	2.68
2022-07	0	3.74
2022-08	0	3.95
2022-09	0	5.42
2022-10	0	5.82
2022-11	0	3.89
2022-12	0	5.74
2023-01	0	3.73
2023-02	0	6.29
2023-03	0	5.15
2023-04	0	6.26
2023-05	0	5.15
2023-06	0	5.86
2023-07	0	4.85
2023-08	0	5.52
2023-09	0	4.63
2023-10	0	8.55
2023-11	0	6.86
2023-12	0	7.35
2024-01	0	9.97
2024-02	0	5.05
2024-03	0	4.14
2024-04	0	7.54
2024-05	0	5.44
2024-06	0	11.44
2024-07	0	6.11
2024-08	0	9.62
2024-09	0	13.25
2024-10	0	6.5
2024-11	0	4.24
2024-12	0	5.88
2025-01	0	4.57
2025-02	0	6.53
2025-03	0	11.14
2025-04	0	8.25
2025-05	0	8.45
2025-06	0	6.73
2025-07	0	6.06
2025-08	0	11.61
2025-09	0	6.9
2025-10	0	5.76
2025-11	0	8.29
2025-12	0	8.87
2026-01	0	15.38
2026-02	0	16.34
2026-03	0	10.95
2026-04	0	15.03
2026-05	0	15.42
2026-06	0	23.48

This device (reports/month)Average device in GDF, KNW (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
2020-02-19	9726768	Malfunction	Available	catalog number

Regulatory clearances

None linked.

Manufacturer compliance record

Date	Type	Outcome	Facility	Citations
2022-10-19	VAI	Voluntary action indicated	Carefusion 2200 Inc	2
2018-11-15	NAI	No action indicated	Carefusion 2200 Inc	0
2015-05-07	VAI	Voluntary action indicated	Carefusion 2200 Inc	2
2014-06-06	WL	Warning Letter	Carefusion 2200 Inc	—
2013-11-05	OAI	Official action indicated	Carefusion 2200 Inc	7
2011-09-07	VAI	Voluntary action indicated	Carefusion 2200 Inc	3

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