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Aspira®

Model B · Merit Medical Systems, Inc. · DI 00884450620540

PNG — Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling · Class II · 21 CFR 876.5630

UDILibrary device dossier · generated 2026-09-16 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (0)

Caveat (required reading): 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 is a reporting baseline (average device in the same product code), not a risk measure.

358102019-01: 0 reports for this device; peer average 1/device2019-07: 0 reports for this device; peer average 3/device2019-12: 0 reports for this device; peer average 2/device2020-07: 0 reports for this device; peer average 1/device2020-11: 0 reports for this device; peer average 3.5/device2020-12: 0 reports for this device; peer average 2.33/device2021-01: 0 reports for this device; peer average 7.5/device2021-02: 0 reports for this device; peer average 1/device2021-03: 0 reports for this device; peer average 3.33/device2021-04: 0 reports for this device; peer average 8/device2021-05: 0 reports for this device; peer average 3.5/device2021-06: 0 reports for this device; peer average 3.5/device2021-07: 0 reports for this device; peer average 6/device2021-08: 0 reports for this device; peer average 2/device2021-09: 0 reports for this device; peer average 3/device2021-10: 0 reports for this device; peer average 2/device2021-11: 0 reports for this device; peer average 2.25/device2021-12: 0 reports for this device; peer average 2/device2022-01: 0 reports for this device; peer average 1/device2022-02: 0 reports for this device; peer average 5.5/device2022-03: 0 reports for this device; peer average 1/device2022-04: 0 reports for this device; peer average 1/device2022-05: 0 reports for this device; peer average 1/device2022-06: 0 reports for this device; peer average 1/device2022-07: 0 reports for this device; peer average 1/device2022-08: 0 reports for this device; peer average 1.33/device2022-09: 0 reports for this device; peer average 1/device2022-10: 0 reports for this device; peer average 1/device2022-11: 0 reports for this device; peer average 1/device2022-12: 0 reports for this device; peer average 1/device2023-01: 0 reports for this device; peer average 1.2/device2023-02: 0 reports for this device; peer average 2.25/device2023-03: 0 reports for this device; peer average 1.67/device2023-04: 0 reports for this device; peer average 2/device2023-05: 0 reports for this device; peer average 2/device2023-07: 0 reports for this device; peer average 1.75/device2023-08: 0 reports for this device; peer average 1/device2023-09: 0 reports for this device; peer average 1.33/device2023-10: 0 reports for this device; peer average 1.33/device2023-11: 0 reports for this device; peer average 1.5/device2023-12: 0 reports for this device; peer average 1/device2024-01: 0 reports for this device; peer average 1/device2024-02: 0 reports for this device; peer average 1/device2024-03: 0 reports for this device; peer average 1/device2024-04: 0 reports for this device; peer average 1.67/device2024-05: 0 reports for this device; peer average 2/device2024-06: 0 reports for this device; peer average 1/device2024-07: 0 reports for this device; peer average 1/device2024-08: 0 reports for this device; peer average 3/device2024-09: 0 reports for this device; peer average 1/device2024-10: 0 reports for this device; peer average 1.5/device2024-11: 0 reports for this device; peer average 2/device2024-12: 0 reports for this device; peer average 1.33/device2025-01: 0 reports for this device; peer average 1.5/device2025-05: 0 reports for this device; peer average 1.67/device2025-06: 0 reports for this device; peer average 1/device2025-07: 0 reports for this device; peer average 1.67/device2025-08: 0 reports for this device; peer average 1.5/device2025-09: 0 reports for this device; peer average 1.5/device2025-10: 0 reports for this device; peer average 4.33/device2025-11: 0 reports for this device; peer average 1/device2025-12: 0 reports for this device; peer average 1/device2026-01: 0 reports for this device; peer average 1.67/device2026-02: 0 reports for this device; peer average 1/device2026-03: 0 reports for this device; peer average 1/device2026-04: 0 reports for this device; peer average 5.75/device2026-05: 0 reports for this device; peer average 10/device2026-06: 0 reports for this device; peer average 1/device0107120711120102030405060708091011120102030405060708091011120102030405070809101112010203040506070809101112010506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101
2019-0703
2019-1202
2020-0701
2020-1103.5
2020-1202.33
2021-0107.5
2021-0201
2021-0303.33
2021-0408
2021-0503.5
2021-0603.5
2021-0706
2021-0802
2021-0903
2021-1002
2021-1102.25
2021-1202
2022-0101
2022-0205.5
2022-0301
2022-0401
2022-0501
2022-0601
2022-0701
2022-0801.33
2022-0901
2022-1001
2022-1101
2022-1201
2023-0101.2
2023-0202.25
2023-0301.67
2023-0402
2023-0502
2023-0701.75
2023-0801
2023-0901.33
2023-1001.33
2023-1101.5
2023-1201
2024-0101
2024-0201
2024-0301
2024-0401.67
2024-0502
2024-0601
2024-0701
2024-0803
2024-0901
2024-1001.5
2024-1102
2024-1201.33
2025-0101.5
2025-0501.67
2025-0601
2025-0701.67
2025-0801.5
2025-0901.5
2025-1004.33
2025-1101
2025-1201
2026-0101.67
2026-0201
2026-0301
2026-0405.75
2026-05010
2026-0601
This device (reports/month)Average device in PNG (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — Merit Medical Systems, Inc.

  • Warning Letter 2012-01-30 Merit Medical Ireland Ltd.
  • NAI 2025-02-19 KA Medical LLC · 0 citations
  • NAI 2024-11-22 Merit Medical Systems, Inc. · 0 citations
  • NAI 2024-11-22 Merit Medical Systems, Inc. · 0 citations
  • NAI 2023-10-06 Merit Medical Systems, Inc. · 0 citations
  • NAI 2023-10-06 Merit Medical Systems, Inc. · 0 citations
  • NAI 2021-12-10 Merit Medical Systems, Inc. · 0 citations
  • NAI 2021-12-10 Merit Medical Systems, Inc. · 0 citations
  • NAI 2020-03-17 KA Medical LLC · 0 citations
  • VAI 2017-12-07 Merit Medical Systems, Inc. · 1 citations
  • VAI 2017-12-07 Merit Medical Systems, Inc. · 1 citations
  • NAI 2017-03-15 Merit Medical Systems, Inc. · 0 citations
  • NAI 2017-03-15 Merit Medical Systems, Inc. · 0 citations
  • VAI 2016-09-27 Merit Medical Systems, Inc. · 5 citations
  • VAI 2016-09-27 Merit Medical Systems, Inc. · 5 citations
  • VAI 2016-09-09 Cianna Medical, Inc. · 1 citations
  • NAI 2016-06-23 Merit Medical Systems, Inc. · 0 citations
  • NAI 2016-06-23 Merit Medical Systems, Inc. · 0 citations
  • VAI 2016-06-16 BioSphere Medical S.A. · 8 citations
  • NAI 2016-03-22 Merit Medical Systems, Inc. · 0 citations
  • NAI 2016-03-22 Merit Medical Systems, Inc. · 0 citations