2D Helical - 35 · 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	1.37
2019-02	0	1.37
2019-03	0	1.48
2019-04	0	1.49
2019-05	0	1.17
2019-06	0	1.12
2019-07	0	1.11
2019-08	0	1.13
2019-09	0	1.61
2019-10	0	1.62
2019-11	0	2.63
2019-12	0	1.2
2020-01	0	1.19
2020-02	1	1.77
2020-03	0	1.66
2020-04	0	2.65
2020-05	0	1.44
2020-06	0	1.2
2020-07	0	1.89
2020-08	0	1.9
2020-09	0	4.48
2020-10	0	2.06
2020-11	0	1.27
2020-12	0	1.97
2021-01	0	1.27
2021-02	0	1.19
2021-03	0	1.33
2021-04	0	1.88
2021-05	0	1.77
2021-06	0	1.3
2021-07	0	1.91
2021-08	0	2
2021-09	0	1.26
2021-10	0	1.87
2021-11	0	1.9
2021-12	0	3.67
2022-01	0	3.14
2022-02	0	1.43
2022-03	0	1.81
2022-04	0	1.38
2022-05	0	1.13
2022-06	0	1.11
2022-07	0	1.36
2022-08	0	1.82
2022-09	0	1.1
2022-10	0	3.21
2022-11	0	1.13
2022-12	0	1.13
2023-01	0	1.14
2023-02	0	1.13
2023-03	0	1.85
2023-04	0	2.6
2023-05	0	1.12
2023-06	0	1.81
2023-07	0	1.89
2023-08	0	1.51
2023-09	0	1.4
2023-10	0	1.45
2023-11	0	1.53
2023-12	0	1.29
2024-01	0	1.55
2024-02	0	1.3
2024-03	0	1.43
2024-04	0	1.38
2024-05	0	1.37
2024-06	0	1.4
2024-07	0	1.42
2024-08	0	1.34
2024-09	0	1.54
2024-10	0	1.54
2024-11	0	1.65
2024-12	0	1.75
2025-01	0	1.56
2025-02	0	1.86
2025-03	0	1.71
2025-04	0	1.71
2025-05	0	1.65
2025-06	0	1.94
2025-07	0	1.84
2025-08	0	1.74
2025-09	0	1.63
2025-10	0	1.85
2025-11	0	1.54
2025-12	0	2.05
2026-01	0	1.72
2026-02	0	1.81
2026-03	0	1.73
2026-04	0	2.01
2026-05	0	1.89
2026-06	0	1.84

This device (reports/month)Average device in KRD (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
2020-02-27	2134265-2020-02027	Malfunction	Available	exact di

Regulatory clearances

None linked.

Manufacturer compliance record

Date	Type	Outcome	Facility	Citations
2025-04-07	OAI	Official action indicated	Boston Scientific Corporation	9
2025-04-07	OAI	Official action indicated	Boston Scientific Corporation	9
2025-03-18	NAI	No action indicated	Boston Scientific Corporation	0
2025-03-18	NAI	No action indicated	Boston Scientific Corporation	0
2024-12-06	NAI	No action indicated	Nalu Medical, Inc.	0
2024-11-26	VAI	Voluntary action indicated	Boston Scientific Corporation	3
2024-11-26	VAI	Voluntary action indicated	Boston Scientific Corporation	3
2024-06-13	NAI	No action indicated	Elutia Inc	0
2024-01-23	VAI	Voluntary action indicated	Silk Road Medical	1
2023-12-05	NAI	No action indicated	Valencia Technologies Corporation	0
2023-12-01	VAI	Voluntary action indicated	Corbin Clinical Resources, Llc	1
2023-08-01	NAI	No action indicated	Boston Scientific Corporation	0
2023-08-01	NAI	No action indicated	Boston Scientific Corporation	0
2023-04-05	NAI	No action indicated	Intera Oncology, Inc.	0
2022-07-28	NAI	No action indicated	Boston Scientific Corporation	0
2022-07-28	NAI	No action indicated	Boston Scientific Corporation	0
2022-06-02	VAI	Voluntary action indicated	Boston Scientific de Costa Rica SRL	0
2022-03-23	NAI	No action indicated	Axonics, Inc.	0
2021-11-17	VAI	Voluntary action indicated	Valencia Technologies Corporation	1
2021-10-29	NAI	No action indicated	Boston Scientific Corporation	0
2014-04-10	WL	Warning Letter	Boston Scientific Corporation	—

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