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Affirm Lateral Arm Upright Biopsy Accessory

Model ASY-03723 · Hologic, Inc. · DI 15420045506817

IZH — System, X-Ray, Mammographic · Class II · 21 CFR 892.1710

UDILibrary device dossier · generated 2026-09-15 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (1)

InitiatedRecall #ClassStatusReasonLink basis
2017-07-07Z-0351-2018Class IITerminatedThe firm is implementing a product correction involving its Affirm Lateral Arm Upright Biopsy Accessory, ASY-09880. The correction has been initiated due to a component (the Left-hand Guide or the Blue Needle Guide) issue that could impact needle alignment for all the left-approach lateral biopsy procedures. This may have an impact on the position of the needle within the breast, and thus on the aspiration of the intended tissue. This impact is case-dependent and detectable when imagining is used to confirm needle position and/or tissue acquisition during and after a procedure. There are no known instances of illness or injury.code info di

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.

25792019-01: 0 reports for this device; peer average 6/device2019-02: 0 reports for this device; peer average 2.5/device2019-03: 0 reports for this device; peer average 4.5/device2019-04: 0 reports for this device; peer average 7/device2019-05: 0 reports for this device; peer average 4/device2019-06: 0 reports for this device; peer average 4/device2019-07: 0 reports for this device; peer average 3.5/device2019-08: 0 reports for this device; peer average 4.5/device2019-09: 0 reports for this device; peer average 3/device2019-11: 0 reports for this device; peer average 9/device2019-12: 0 reports for this device; peer average 3/device2020-01: 0 reports for this device; peer average 3/device2020-02: 0 reports for this device; peer average 3.67/device2020-09: 0 reports for this device; peer average 3/device2021-02: 0 reports for this device; peer average 1/device2021-05: 0 reports for this device; peer average 3/device2021-09: 0 reports for this device; peer average 3.5/device2021-11: 0 reports for this device; peer average 2/device2022-01: 0 reports for this device; peer average 2/device2022-09: 0 reports for this device; peer average 1/device2022-10: 0 reports for this device; peer average 1/device2023-01: 0 reports for this device; peer average 4/device2023-02: 0 reports for this device; peer average 2.5/device2023-06: 0 reports for this device; peer average 3/device2024-02: 0 reports for this device; peer average 3/device2024-04: 0 reports for this device; peer average 3/device2024-08: 0 reports for this device; peer average 3/device2024-09: 0 reports for this device; peer average 1/device2025-02: 0 reports for this device; peer average 2/device2025-04: 0 reports for this device; peer average 2.5/device2025-08: 0 reports for this device; peer average 2/device2025-09: 0 reports for this device; peer average 6/device2025-10: 0 reports for this device; peer average 9/device2025-11: 0 reports for this device; peer average 4.5/device2025-12: 0 reports for this device; peer average 3/device2026-01: 0 reports for this device; peer average 4/device2026-02: 0 reports for this device; peer average 6/device2026-03: 0 reports for this device; peer average 5.5/device2026-04: 0 reports for this device; peer average 2/device2026-05: 0 reports for this device; peer average 2/device2026-06: 0 reports for this device; peer average 3/device0102030405060708091112010209020509110109100102060204080902040809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0106
2019-0202.5
2019-0304.5
2019-0407
2019-0504
2019-0604
2019-0703.5
2019-0804.5
2019-0903
2019-1109
2019-1203
2020-0103
2020-0203.67
2020-0903
2021-0201
2021-0503
2021-0903.5
2021-1102
2022-0102
2022-0901
2022-1001
2023-0104
2023-0202.5
2023-0603
2024-0203
2024-0403
2024-0803
2024-0901
2025-0202
2025-0402.5
2025-0802
2025-0906
2025-1009
2025-1104.5
2025-1203
2026-0104
2026-0206
2026-0305.5
2026-0402
2026-0502
2026-0603
This device (reports/month)Average device in IZH (reports/device/month)

Regulatory clearances

  • K161575 SESE 2016-08-10 (k number procode)

Predicate lineage

K161575 — cites (transitively): K040125 (d1), K122836 (d1), K103512 (d2), K071542 (d3) — cited as predicate by K182951, K202294

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — Hologic, Inc.

  • Warning Letter 2024-12-18 Hologic, Inc
  • Warning Letter 2024-12-18 Hologic, Inc
  • OAI 2025-11-04 Hologic, Inc · 3 citations
  • OAI 2025-11-04 Hologic, Inc · 3 citations
  • OAI 2024-09-24 Hologic, Inc · 5 citations
  • OAI 2024-09-24 Hologic, Inc · 5 citations
  • VAI 2024-09-12 Hologic Surgical Products Costa Rica, S.R.L. · 0 citations
  • NAI 2024-08-13 Hologic, Inc. · 0 citations
  • NAI 2024-08-13 Hologic, Inc. · 0 citations
  • NAI 2022-12-14 Bolder Surgical, LLC · 0 citations
  • OAI 2022-10-14 Hologic, Inc. · 4 citations
  • OAI 2022-10-14 Hologic, Inc. · 4 citations
  • VAI 2022-08-03 Health Beacons, Inc. · 1 citations
  • NAI 2020-02-25 Health Beacons, Inc. · 0 citations
  • NAI 2018-12-10 Hologic, Inc. · 0 citations
  • NAI 2018-12-10 Hologic, Inc. · 0 citations
  • NAI 2018-02-27 Gynesonics, Inc. · 0 citations
  • NAI 2017-11-30 Hologic, Inc · 0 citations
  • NAI 2017-11-30 Hologic, Inc · 0 citations
  • VAI 2017-11-27 Bolder Surgical, LLC · 6 citations
  • NAI 2017-10-25 Hologic, Inc. · 0 citations
  • NAI 2017-10-25 Hologic, Inc. · 0 citations