BALLOON · 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.

186 linked reportsMalfunction 136Injury 49Other 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	1	2.11
2019-02	1	2.83
2019-03	1	4.45
2019-04	0	8.57
2019-05	0	3.46
2019-06	0	4.34
2019-07	0	3.23
2019-08	0	4.11
2019-09	0	2.78
2019-10	0	2.84
2019-11	0	2.83
2019-12	0	3.8
2020-01	0	2.23
2020-02	0	4.24
2020-03	0	3.4
2020-04	0	3.58
2020-05	0	3.82
2020-06	0	3.23
2020-07	0	4.31
2020-08	0	3.34
2020-09	3	2.98
2020-10	1	4.23
2020-11	2	4.3
2020-12	0	6.79
2021-01	3	6.05
2021-02	1	5.82
2021-03	1	6.73
2021-04	0	5.56
2021-05	0	6.49
2021-06	0	5.95
2021-07	7	6.73
2021-08	0	7.1
2021-09	0	7.73
2021-10	0	6.33
2021-11	1	6.4
2021-12	1	8.54
2022-01	1	7.42
2022-02	0	8.29
2022-03	0	8.78
2022-04	4	8.94
2022-05	7	8.67
2022-06	3	8.67
2022-07	9	9.29
2022-08	6	9
2022-09	14	7.7
2022-10	4	7.71
2022-11	11	7.87
2022-12	7	8.15
2023-01	5	8.09
2023-02	0	6.76
2023-03	1	8.99
2023-04	2	7.54
2023-05	12	8.23
2023-06	5	7.73
2023-07	0	8.04
2023-08	0	9.35
2023-09	1	8.38
2023-10	9	9.1
2023-11	4	8.71
2023-12	6	8.61
2024-01	0	8.81
2024-02	4	7.96
2024-03	6	9.63
2024-04	6	8.19
2024-05	0	7.31
2024-06	4	8.17
2024-07	2	7.75
2024-08	1	7.76
2024-09	2	7.13
2024-10	12	8.77
2024-11	2	6.93
2024-12	0	6.05
2025-01	1	4.72
2025-02	0	4.65
2025-03	1	5.94
2025-04	0	5.07
2025-05	1	5.67
2025-06	0	5.99
2025-07	0	5.75
2025-08	1	6.64
2025-09	0	6.13
2025-10	1	9.41
2025-11	0	14.75
2025-12	0	24.02
2026-01	1	17.43
2026-02	1	10.41
2026-03	2	11.28
2026-04	0	15.39
2026-05	2	17.68
2026-06	2	16.68

This device (reports/month)Average device in EOQ, FDS, ITX, ODG (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
2026-06-12	9614641-2026-00617	Malfunction	Available	exact di
2026-06-01	MW5188781	Malfunction	Available	model number
2026-05-04	MW5187586	Injury	Available	model number
2026-05-04	MW5187585	Injury	Available	model number
2026-03-02	2429304-2026-00027	Injury	Available	exact di
2026-03-02	9614641-2026-00253	Injury	Available	exact di
2026-02-17	9614641-2026-00200	Malfunction	Available	exact di
2026-01-12	9614641-2026-00044	Injury	Available	exact di
2025-10-30	23423963	Malfunction	Available	model number
2025-08-25	22885476	Malfunction	Available	model number
2025-05-06	9614641-2025-00665	Malfunction	Available	exact di
2025-03-20	9614641-2025-00346	Malfunction	Available	exact di
2025-01-31	9614641-2025-00105	Malfunction	Available	exact di
2024-11-11	2429304-2024-0000454	Injury	Available	exact di
2024-11-11	9614641-2024-02081	Injury	Available	exact di

Showing 1–15 of 186

Regulatory clearances

None linked.

Manufacturer compliance record

Date	Type	Outcome	Facility	Citations
2022-12-12	WL	Warning Letter	Olympus Medical Systems Corporation	—
2022-09-09	OAI	Official action indicated	Olympus Medical Systems Corporation	1
2018-03-09	WL	Warning Letter	Olympus Medical Systems Corporation	—
2015-04-24	OAI	Official action indicated	Olympus Medical Systems Corporation	2

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