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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.

4 linked reportsInjury 4
24572019-01: 0 reports for this device; peer average 2.43/device2019-02: 0 reports for this device; peer average 3.17/device2019-03: 0 reports for this device; peer average 2.38/device2019-04: 0 reports for this device; peer average 2.71/device2019-05: 0 reports for this device; peer average 2.2/device2019-06: 0 reports for this device; peer average 1.83/device2019-07: 0 reports for this device; peer average 2.06/device2019-08: 0 reports for this device; peer average 5.89/device2019-09: 0 reports for this device; peer average 2.27/device2019-10: 0 reports for this device; peer average 3.87/device2019-11: 0 reports for this device; peer average 3.75/device2019-12: 0 reports for this device; peer average 3.25/device2020-01: 0 reports for this device; peer average 3/device2020-02: 0 reports for this device; peer average 2.17/device2020-03: 0 reports for this device; peer average 3.43/device2020-04: 0 reports for this device; peer average 2.43/device2020-05: 0 reports for this device; peer average 4.29/device2020-06: 0 reports for this device; peer average 3/device2020-07: 0 reports for this device; peer average 2.67/device2020-08: 0 reports for this device; peer average 2.13/device2020-09: 0 reports for this device; peer average 2.25/device2020-10: 0 reports for this device; peer average 2.67/device2020-11: 0 reports for this device; peer average 2.69/device2020-12: 0 reports for this device; peer average 2.54/device2021-01: 0 reports for this device; peer average 2/device2021-02: 0 reports for this device; peer average 2.67/device2021-03: 0 reports for this device; peer average 2.13/device2021-04: 0 reports for this device; peer average 2.09/device2021-05: 0 reports for this device; peer average 2/device2021-06: 0 reports for this device; peer average 3.23/device2021-07: 0 reports for this device; peer average 4.67/device2021-08: 0 reports for this device; peer average 1.83/device2021-09: 0 reports for this device; peer average 3/device2021-10: 0 reports for this device; peer average 2.67/device2021-11: 0 reports for this device; peer average 2.13/device2021-12: 0 reports for this device; peer average 3.11/device2022-01: 0 reports for this device; peer average 2/device2022-02: 0 reports for this device; peer average 2.8/device2022-03: 0 reports for this device; peer average 4.14/device2022-04: 0 reports for this device; peer average 2.7/device2022-05: 0 reports for this device; peer average 2.5/device2022-06: 0 reports for this device; peer average 4.5/device2022-07: 0 reports for this device; peer average 1.88/device2022-08: 0 reports for this device; peer average 2.86/device2022-09: 0 reports for this device; peer average 2.4/device2022-10: 0 reports for this device; peer average 3/device2022-11: 0 reports for this device; peer average 4/device2022-12: 0 reports for this device; peer average 4/device2023-01: 0 reports for this device; peer average 2.5/device2023-02: 0 reports for this device; peer average 3.29/device2023-03: 0 reports for this device; peer average 4.5/device2023-04: 0 reports for this device; peer average 3.83/device2023-05: 0 reports for this device; peer average 3.5/device2023-06: 0 reports for this device; peer average 3.4/device2023-07: 0 reports for this device; peer average 4.36/device2023-08: 0 reports for this device; peer average 2.79/device2023-09: 0 reports for this device; peer average 3/device2023-10: 0 reports for this device; peer average 2.25/device2023-11: 0 reports for this device; peer average 2/device2023-12: 0 reports for this device; peer average 2.4/device2024-01: 0 reports for this device; peer average 5/device2024-02: 0 reports for this device; peer average 4.43/device2024-03: 0 reports for this device; peer average 2.38/device2024-04: 0 reports for this device; peer average 2/device2024-05: 0 reports for this device; peer average 2.17/device2024-06: 0 reports for this device; peer average 4/device2024-07: 0 reports for this device; peer average 2/device2024-08: 0 reports for this device; peer average 1.83/device2024-09: 0 reports for this device; peer average 1.5/device2024-10: 0 reports for this device; peer average 2/device2024-11: 0 reports for this device; peer average 1.5/device2024-12: 0 reports for this device; peer average 2.14/device2025-01: 0 reports for this device; peer average 2.36/device2025-02: 0 reports for this device; peer average 1/device2025-03: 0 reports for this device; peer average 2/device2025-04: 0 reports for this device; peer average 2.5/device2025-05: 0 reports for this device; peer average 3.71/device2025-06: 0 reports for this device; peer average 1.78/device2025-07: 0 reports for this device; peer average 4.57/device2025-08: 0 reports for this device; peer average 2/device2025-09: 0 reports for this device; peer average 1/device2025-10: 0 reports for this device; peer average 3/device2025-11: 0 reports for this device; peer average 2.75/device2025-12: 0 reports for this device; peer average 2.5/device2026-01: 0 reports for this device; peer average 1.5/device2026-02: 0 reports for this device; peer average 1.8/device2026-03: 0 reports for this device; peer average 3.35/device2026-04: 0 reports for this device; peer average 7.33/device2026-05: 2 reports for this device; peer average 3.44/device2026-06: 2 reports for this device; peer average 4.2/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.43
2019-0203.17
2019-0302.38
2019-0402.71
2019-0502.2
2019-0601.83
2019-0702.06
2019-0805.89
2019-0902.27
2019-1003.87
2019-1103.75
2019-1203.25
2020-0103
2020-0202.17
2020-0303.43
2020-0402.43
2020-0504.29
2020-0603
2020-0702.67
2020-0802.13
2020-0902.25
2020-1002.67
2020-1102.69
2020-1202.54
2021-0102
2021-0202.67
2021-0302.13
2021-0402.09
2021-0502
2021-0603.23
2021-0704.67
2021-0801.83
2021-0903
2021-1002.67
2021-1102.13
2021-1203.11
2022-0102
2022-0202.8
2022-0304.14
2022-0402.7
2022-0502.5
2022-0604.5
2022-0701.88
2022-0802.86
2022-0902.4
2022-1003
2022-1104
2022-1204
2023-0102.5
2023-0203.29
2023-0304.5
2023-0403.83
2023-0503.5
2023-0603.4
2023-0704.36
2023-0802.79
2023-0903
2023-1002.25
2023-1102
2023-1202.4
2024-0105
2024-0204.43
2024-0302.38
2024-0402
2024-0502.17
2024-0604
2024-0702
2024-0801.83
2024-0901.5
2024-1002
2024-1101.5
2024-1202.14
2025-0102.36
2025-0201
2025-0302
2025-0402.5
2025-0503.71
2025-0601.78
2025-0704.57
2025-0802
2025-0901
2025-1003
2025-1102.75
2025-1202.5
2026-0101.5
2026-0201.8
2026-0303.35
2026-0407.33
2026-0523.44
2026-0624.2
This device (reports/month)Average device in DSY (reports/device/month)
Failure-mode summaryAI-generated

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

Recall history
InitiatedRecall #ClassStatusReasonQuantityLink basis
2024-05-03Z-1992-2024Class IIOpen, ClassifiedComplaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.Distribution: Worldwide distribution - US Nationwide including Puerto Rico, and the countries of AE, AR, AT, AU, BE, BG, BO, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DZ, EC, EE, EG, ES, FI, FR, GB, GR, HK, ID, IE, IL, IQ, IT, JO, JP, KR, KW, LT, LU, LV, ME, MN, MU, MX, MY, NI, NL, NO, NZ, OM, PA, PE, PH, PK, PL, PT, PY, RO, RU, SA, SE, SG, SI, SV, TH, TN, TR, TW, UA, VN, XK, YE, ZA.53,308 units (US: 11, 236; OUS: 42,072)clearance family
2024-05-03Z-1990-2024Class IIOpen, ClassifiedComplaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.Distribution: Worldwide distribution - US Nationwide including Puerto Rico, and the countries of AE, AR, AT, AU, BE, BG, BO, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DZ, EC, EE, EG, ES, FI, FR, GB, GR, HK, ID, IE, IL, IQ, IT, JO, JP, KR, KW, LT, LU, LV, ME, MN, MU, MX, MY, NI, NL, NO, NZ, OM, PA, PE, PH, PK, PL, PT, PY, RO, RU, SA, SE, SG, SI, SV, TH, TN, TR, TW, UA, VN, XK, YE, ZA.53,308 units (US: 11, 236; OUS: 42,072)clearance family
2024-05-03Z-1991-2024Class IIOpen, ClassifiedComplaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.Distribution: Worldwide distribution - US Nationwide including Puerto Rico, and the countries of AE, AR, AT, AU, BE, BG, BO, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DZ, EC, EE, EG, ES, FI, FR, GB, GR, HK, ID, IE, IL, IQ, IT, JO, JP, KR, KW, LT, LU, LV, ME, MN, MU, MX, MY, NI, NL, NO, NZ, OM, PA, PE, PH, PK, PL, PT, PY, RO, RU, SA, SE, SG, SI, SV, TH, TN, TR, TW, UA, VN, XK, YE, ZA.53,308 units (US: 11, 236; OUS: 42,072)clearance family
2024-05-03Z-1952-2024Class IIOpen, ClassifiedComplaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.Distribution: Worldwide distribution - US Nationwide including Puerto Rico, and the countries of AE, AR, AT, AU, BE, BG, BO, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DZ, EC, EE, EG, ES, FI, FR, GB, GR, HK, ID, IE, IL, IQ, IT, JO, JP, KR, KW, LT, LU, LV, ME, MN, MU, MX, MY, NI, NL, NO, NZ, OM, PA, PE, PH, PK, PL, PT, PY, RO, RU, SA, SE, SG, SI, SV, TH, TN, TR, TW, UA, VN, XK, YE, ZA.53,308 units (US: 11,236; OUS: 42,072)clearance family
2024-05-03Z-1953-2024Class IIOpen, ClassifiedComplaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.Distribution: Worldwide distribution - US Nationwide including Puerto Rico, and the countries of AE, AR, AT, AU, BE, BG, BO, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DZ, EC, EE, EG, ES, FI, FR, GB, GR, HK, ID, IE, IL, IQ, IT, JO, JP, KR, KW, LT, LU, LV, ME, MN, MU, MX, MY, NI, NL, NO, NZ, OM, PA, PE, PH, PK, PL, PT, PY, RO, RU, SA, SE, SG, SI, SV, TH, TN, TR, TW, UA, VN, XK, YE, ZA.53,308 units (US: 11,236; OUS: 42,072)clearance family
2024-05-03Z-1955-2024Class IIOpen, ClassifiedComplaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.Distribution: Worldwide distribution - US Nationwide including Puerto Rico, and the countries of AE, AR, AT, AU, BE, BG, BO, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DZ, EC, EE, EG, ES, FI, FR, GB, GR, HK, ID, IE, IL, IQ, IT, JO, JP, KR, KW, LT, LU, LV, ME, MN, MU, MX, MY, NI, NL, NO, NZ, OM, PA, PE, PH, PK, PL, PT, PY, RO, RU, SA, SE, SG, SI, SV, TH, TN, TR, TW, UA, VN, XK, YE, ZA.53,308 units (US: 11,236; OUS: 42,072)clearance family
2024-05-03Z-1956-2024Class IIOpen, ClassifiedComplaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.Distribution: Worldwide distribution - US Nationwide including Puerto Rico, and the countries of AE, AR, AT, AU, BE, BG, BO, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DZ, EC, EE, EG, ES, FI, FR, GB, GR, HK, ID, IE, IL, IQ, IT, JO, JP, KR, KW, LT, LU, LV, ME, MN, MU, MX, MY, NI, NL, NO, NZ, OM, PA, PE, PH, PK, PL, PT, PY, RO, RU, SA, SE, SG, SI, SV, TH, TN, TR, TW, UA, VN, XK, YE, ZA.53,308 units (US: 11,236 ; OUS: 42,072)clearance family
2024-05-03Z-1957-2024Class IIOpen, ClassifiedComplaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.Distribution: Worldwide distribution - US Nationwide including Puerto Rico, and the countries of AE, AR, AT, AU, BE, BG, BO, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DZ, EC, EE, EG, ES, FI, FR, GB, GR, HK, ID, IE, IL, IQ, IT, JO, JP, KR, KW, LT, LU, LV, ME, MN, MU, MX, MY, NI, NL, NO, NZ, OM, PA, PE, PH, PK, PL, PT, PY, RO, RU, SA, SE, SG, SI, SV, TH, TN, TR, TW, UA, VN, XK, YE, ZA.53,308 units (US: 11, 236; OUS: 42,072)clearance family
2024-05-03Z-1959-2024Class IIOpen, ClassifiedComplaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.Distribution: Worldwide distribution - US Nationwide including Puerto Rico, and the countries of AE, AR, AT, AU, BE, BG, BO, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DZ, EC, EE, EG, ES, FI, FR, GB, GR, HK, ID, IE, IL, IQ, IT, JO, JP, KR, KW, LT, LU, LV, ME, MN, MU, MX, MY, NI, NL, NO, NZ, OM, PA, PE, PH, PK, PL, PT, PY, RO, RU, SA, SE, SG, SI, SV, TH, TN, TR, TW, UA, VN, XK, YE, ZA.53,308 units (US: 11, 236; OUS: 42,072)clearance family
2024-05-03Z-1960-2024Class IIOpen, ClassifiedComplaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.Distribution: Worldwide distribution - US Nationwide including Puerto Rico, and the countries of AE, AR, AT, AU, BE, BG, BO, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DZ, EC, EE, EG, ES, FI, FR, GB, GR, HK, ID, IE, IL, IQ, IT, JO, JP, KR, KW, LT, LU, LV, ME, MN, MU, MX, MY, NI, NL, NO, NZ, OM, PA, PE, PH, PK, PL, PT, PY, RO, RU, SA, SE, SG, SI, SV, TH, TN, TR, TW, UA, VN, XK, YE, ZA.53,308 units (US: 11, 236; OUS: 42,072)clearance family
Showing 1–10 of 39
Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2026-06-183011175548-2026-000007InjuryAvailableexact di
2026-05-193011175548-2026-000005InjuryAvailableexact di

Showing the most recent 2 of 4 linked reports.

Regulatory clearances

    Predicate lineage

    K992960

    Cited as predicate by: K231972

    Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.

    Manufacturer compliance record
    DateTypeOutcomeFacilityCitations
    2024-11-26VAIVoluntary action indicatedAtrium Medical Corporation8
    2024-11-26VAIVoluntary action indicatedAtrium Medical Corporation8
    2022-09-06VAIVoluntary action indicatedAtrium Medical Corporation0
    2022-09-06VAIVoluntary action indicatedAtrium Medical Corporation0
    2020-02-10OAIOfficial action indicatedAtrium Medical Corporation0
    2020-02-10OAIOfficial action indicatedAtrium Medical Corporation0
    2018-08-02NAINo action indicatedAtrium Medical Corporation0
    2018-08-02NAINo action indicatedAtrium Medical Corporation0
    2016-07-13OAIOfficial action indicatedAtrium Medical Corporation0
    2016-07-13OAIOfficial action indicatedAtrium Medical Corporation0
    2016-01-08NAINo action indicatedAtrium Medical Corporation0
    2016-01-08NAINo action indicatedAtrium Medical Corporation0
    2013-10-01OAIOfficial action indicatedAtrium Medical Corporation8
    2013-10-01OAIOfficial action indicatedAtrium Medical Corporation8
    2012-10-11WLWarning LetterAtrium Medical Corporation—
    2012-10-11WLWarning LetterAtrium Medical Corporation—
    2012-09-07OAIOfficial action indicatedAtrium Medical Corporation5
    2012-09-07OAIOfficial action indicatedAtrium Medical Corporation5
    2010-03-15VAIVoluntary action indicatedAtrium Medical Corporation0
    2010-03-15VAIVoluntary action indicatedAtrium Medical Corporation0
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