35X-ST ProFlexx® · 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.

18 linked reportsInjury 11Malfunction 7

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	2.41
2019-02	2	1.71
2019-03	0	3
2019-04	0	2.46
2019-05	0	1.89
2019-06	2	2.33
2019-07	0	2.48
2019-08	0	2
2019-09	0	1
2019-10	2	2.59
2019-11	0	1.8
2019-12	0	2.5
2020-01	0	2.8
2020-02	0	2.5
2020-03	0	1.17
2020-04	0	3
2020-05	0	2.8
2020-06	0	1.67
2020-07	0	2.92
2020-08	0	1.15
2020-09	0	1.5
2020-10	0	2.92
2020-11	0	2.25
2020-12	0	1
2021-01	0	4.96
2021-02	0	3.35
2021-03	0	1.67
2021-04	1	2.43
2021-05	0	2
2021-06	0	1.89
2021-07	1	2.47
2021-08	0	1.6
2021-09	0	1.2
2021-10	0	2.83
2021-11	0	1.17
2021-12	0	1.67
2022-01	0	2.72
2022-02	0	1
2022-03	0	1.75
2022-04	0	3.1
2022-05	0	2.33
2022-06	1	1
2022-07	0	3.23
2022-08	0	1.75
2022-09	0	4
2022-10	0	3.29
2022-11	0	1.43
2022-12	0	2
2023-01	0	3.16
2023-02	0	1.67
2023-03	0	2.3
2023-04	0	3.68
2023-05	2	2.33
2023-06	0	2.4
2023-07	1	3.68
2023-08	0	1.63
2023-09	2	1.77
2023-10	0	3.5
2023-11	2	2.5
2023-12	0	2.4
2024-01	0	3.57
2024-02	0	3.17
2024-03	0	1.71
2024-04	0	4.21
2024-05	0	1.43
2024-06	0	2.3
2024-07	0	3.51
2024-08	0	1.57
2024-09	0	7
2024-10	0	4
2024-11	2	5.43
2024-12	0	4.6
2025-01	0	3.77
2025-02	0	6.67
2025-03	0	8
2025-04	0	3.81
2025-05	0	6
2025-06	0	3
2025-07	0	3.23
2025-08	0	5.67
2025-09	0	5
2025-10	0	3.47
2025-11	0	5.67
2025-12	0	3.22
2026-01	0	3.13
2026-02	0	4.67
2026-03	0	5.11
2026-04	0	3.84
2026-05	0	10.43
2026-06	0	7.43

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

Failure-mode summaryAI-generated

18 linked report narratives available — no AI summary generated yet.

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2024-11-22	1523574-2024-00080	Injury	Available	exact di
2023-11-28	1523574-2023-00041	Malfunction	Available	exact di
2023-09-28	1523574-2020-00037	Injury	Available	exact di
2023-07-28	1523574-2023-00024	Malfunction	Available	model number
2023-05-11	1523574-2023-00012	Malfunction	Available	exact di
2022-06-13	1523574-2022-00009	Injury	Available	model number
2021-07-30	1523574-2021-00011	Injury	Available	model number
2021-04-14	1523574-2021-00004	Injury	Available	model number
2019-10-08	1523574-2019-00033	Injury	Available	exact di
2019-06-21	1523574-2019-00021	Malfunction	Available	exact di
2019-02-25	1523574-2019-00009	Injury	Available	exact di

Showing the most recent 11 of 18 linked reports.

Regulatory clearances

None linked.

Manufacturer compliance record

Date	Type	Outcome	Facility	Citations
2023-01-24	VAI	Voluntary action indicated	Ferno-Washington Inc	6
2023-01-24	VAI	Voluntary action indicated	Ferno-Washington Inc	6
2018-07-23	NAI	No action indicated	Ferno-Washington Inc	0
2018-07-23	NAI	No action indicated	Ferno-Washington Inc	0
2015-03-11	VAI	Voluntary action indicated	Ferno-Washington Inc	6
2015-03-11	VAI	Voluntary action indicated	Ferno-Washington Inc	6
2011-09-29	VAI	Voluntary action indicated	Ferno-Washington Inc	6
2011-09-29	VAI	Voluntary action indicated	Ferno-Washington Inc	6

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