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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
12342019-01: 0 reports for this device; peer average 1.64/device2019-02: 0 reports for this device; peer average 1.52/device2019-03: 0 reports for this device; peer average 1.78/device2019-04: 0 reports for this device; peer average 1.69/device2019-05: 0 reports for this device; peer average 1.69/device2019-06: 0 reports for this device; peer average 1.57/device2019-07: 0 reports for this device; peer average 2.02/device2019-08: 0 reports for this device; peer average 2.38/device2019-09: 0 reports for this device; peer average 2.08/device2019-10: 0 reports for this device; peer average 2.24/device2019-11: 0 reports for this device; peer average 2.03/device2019-12: 0 reports for this device; peer average 2.52/device2020-01: 0 reports for this device; peer average 2.3/device2020-02: 0 reports for this device; peer average 2.95/device2020-03: 0 reports for this device; peer average 2.85/device2020-04: 0 reports for this device; peer average 2.16/device2020-05: 0 reports for this device; peer average 2.68/device2020-06: 0 reports for this device; peer average 2.49/device2020-07: 0 reports for this device; peer average 2.84/device2020-08: 0 reports for this device; peer average 2.54/device2020-09: 0 reports for this device; peer average 2.44/device2020-10: 0 reports for this device; peer average 2.65/device2020-11: 0 reports for this device; peer average 2.68/device2020-12: 0 reports for this device; peer average 2.75/device2021-01: 0 reports for this device; peer average 3.03/device2021-02: 0 reports for this device; peer average 2.16/device2021-03: 1 reports for this device; peer average 2.69/device2021-04: 0 reports for this device; peer average 2.62/device2021-05: 0 reports for this device; peer average 2.05/device2021-06: 0 reports for this device; peer average 2.42/device2021-07: 0 reports for this device; peer average 3.07/device2021-08: 0 reports for this device; peer average 2.39/device2021-09: 0 reports for this device; peer average 2.41/device2021-10: 0 reports for this device; peer average 2.02/device2021-11: 0 reports for this device; peer average 2.34/device2021-12: 0 reports for this device; peer average 2.64/device2022-01: 0 reports for this device; peer average 2.63/device2022-02: 0 reports for this device; peer average 2.35/device2022-03: 0 reports for this device; peer average 2.36/device2022-04: 0 reports for this device; peer average 2.61/device2022-05: 0 reports for this device; peer average 2.86/device2022-06: 0 reports for this device; peer average 2.75/device2022-07: 0 reports for this device; peer average 2.57/device2022-08: 0 reports for this device; peer average 3.01/device2022-09: 0 reports for this device; peer average 2.56/device2022-10: 0 reports for this device; peer average 2.26/device2022-11: 0 reports for this device; peer average 2.62/device2022-12: 0 reports for this device; peer average 2.42/device2023-01: 0 reports for this device; peer average 1.86/device2023-02: 0 reports for this device; peer average 2.64/device2023-03: 0 reports for this device; peer average 2.56/device2023-04: 0 reports for this device; peer average 2.25/device2023-05: 0 reports for this device; peer average 2.99/device2023-06: 0 reports for this device; peer average 2.39/device2023-07: 0 reports for this device; peer average 2.63/device2023-08: 0 reports for this device; peer average 2.65/device2023-09: 0 reports for this device; peer average 2.76/device2023-10: 0 reports for this device; peer average 2.54/device2023-11: 0 reports for this device; peer average 2.64/device2023-12: 0 reports for this device; peer average 2.8/device2024-01: 0 reports for this device; peer average 2.65/device2024-02: 0 reports for this device; peer average 2.63/device2024-03: 0 reports for this device; peer average 2.81/device2024-04: 0 reports for this device; peer average 2.26/device2024-05: 0 reports for this device; peer average 3.29/device2024-06: 0 reports for this device; peer average 3.05/device2024-07: 0 reports for this device; peer average 2.31/device2024-08: 0 reports for this device; peer average 3.62/device2024-09: 0 reports for this device; peer average 3.04/device2024-10: 0 reports for this device; peer average 4.01/device2024-11: 0 reports for this device; peer average 3.37/device2024-12: 0 reports for this device; peer average 3.81/device2025-01: 0 reports for this device; peer average 2.98/device2025-02: 0 reports for this device; peer average 3.19/device2025-03: 0 reports for this device; peer average 3.22/device2025-04: 0 reports for this device; peer average 3.49/device2025-05: 0 reports for this device; peer average 3.33/device2025-06: 0 reports for this device; peer average 2.89/device2025-07: 0 reports for this device; peer average 3.12/device2025-08: 0 reports for this device; peer average 3.21/device2025-09: 0 reports for this device; peer average 3.5/device2025-10: 0 reports for this device; peer average 3.24/device2025-11: 0 reports for this device; peer average 3.94/device2025-12: 0 reports for this device; peer average 4.49/device2026-01: 0 reports for this device; peer average 3.58/device2026-02: 0 reports for this device; peer average 3.79/device2026-03: 0 reports for this device; peer average 3.9/device2026-04: 0 reports for this device; peer average 2.99/device2026-05: 0 reports for this device; peer average 2.69/device2026-06: 0 reports for this device; peer average 2.84/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.64
2019-0201.52
2019-0301.78
2019-0401.69
2019-0501.69
2019-0601.57
2019-0702.02
2019-0802.38
2019-0902.08
2019-1002.24
2019-1102.03
2019-1202.52
2020-0102.3
2020-0202.95
2020-0302.85
2020-0402.16
2020-0502.68
2020-0602.49
2020-0702.84
2020-0802.54
2020-0902.44
2020-1002.65
2020-1102.68
2020-1202.75
2021-0103.03
2021-0202.16
2021-0312.69
2021-0402.62
2021-0502.05
2021-0602.42
2021-0703.07
2021-0802.39
2021-0902.41
2021-1002.02
2021-1102.34
2021-1202.64
2022-0102.63
2022-0202.35
2022-0302.36
2022-0402.61
2022-0502.86
2022-0602.75
2022-0702.57
2022-0803.01
2022-0902.56
2022-1002.26
2022-1102.62
2022-1202.42
2023-0101.86
2023-0202.64
2023-0302.56
2023-0402.25
2023-0502.99
2023-0602.39
2023-0702.63
2023-0802.65
2023-0902.76
2023-1002.54
2023-1102.64
2023-1202.8
2024-0102.65
2024-0202.63
2024-0302.81
2024-0402.26
2024-0503.29
2024-0603.05
2024-0702.31
2024-0803.62
2024-0903.04
2024-1004.01
2024-1103.37
2024-1203.81
2025-0102.98
2025-0203.19
2025-0303.22
2025-0403.49
2025-0503.33
2025-0602.89
2025-0703.12
2025-0803.21
2025-0903.5
2025-1003.24
2025-1103.94
2025-1204.49
2026-0103.58
2026-0203.79
2026-0303.9
2026-0402.99
2026-0502.69
2026-0602.84
This device (reports/month)Average device in DQX (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
DateReport #TypeNarrativeLink basis
2021-03-182248146-2021-00167MalfunctionAvailableexact di
Regulatory clearances

None linked.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2023-06-15OAIOfficial action indicatedDatascope Corp.6
2023-06-15OAIOfficial action indicatedDatascope Corp.6
2022-01-21OAIOfficial action indicatedDatascope Corp.13
2022-01-21OAIOfficial action indicatedDatascope Corp.13
2019-02-06WLWarning LetterDatascope Corp.—
2019-02-06WLWarning LetterDatascope Corp.—
2018-10-03OAIOfficial action indicatedDatascope Corp.9
2018-10-03OAIOfficial action indicatedDatascope Corp.9
2018-09-11WLWarning LetterDatascope Corp.—
2018-09-11WLWarning LetterDatascope Corp.—
2018-06-11OAIOfficial action indicatedDatascope Corp.11
2018-06-11OAIOfficial action indicatedDatascope Corp.11
2015-02-03INJInjunctionDatascope Corp.—
2015-02-03INJInjunctionDatascope Corp.—
2013-10-17OAIOfficial action indicatedDatascope Corp.4
2010-04-13VAIVoluntary action indicatedDatascope Corp.2
2010-04-13VAIVoluntary action indicatedDatascope Corp.2
2010-04-01NAINo action indicatedDatascope Corp.0
2010-04-01NAINo action indicatedDatascope Corp.0
2010-03-24NAINo action indicatedDatascope Corp.0
2010-03-24NAINo action indicatedDatascope Corp.0
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