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Carotid WALLSTENT®

Model M001719020 · BOSTON SCIENTIFIC CORPORATION · DI 08714729781202

NIM — Stent, Carotid · Class III

UDILibrary device dossier · generated 2026-09-12 · 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
2025-07-07Z-2273-2025Class IOpen, ClassifiedCertain batches are being removed due to an increase in complaints received in which physicians encountered greater than anticipated resistance while attempting to withdraw the stent delivery system (SDS) from the guidewire or embolic protection device (EPD) after successful stent deployment. The most serious potential adverse health consequence is stroke. Other risks include delay to procedure, vessel injury, vessel spasm, or stent disruption/damage necessitating additional intervention.code info di

Adverse-event reports — MAUDE (14)

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.

Injury: 7 · Malfunction: 7

23562019-01: 0 reports for this device; peer average 1.5/device2019-02: 1 reports for this device; peer average 1/device2019-03: 0 reports for this device; peer average 2.75/device2019-04: 0 reports for this device; peer average 3/device2019-05: 0 reports for this device; peer average 2.67/device2019-06: 0 reports for this device; peer average 2/device2019-07: 0 reports for this device; peer average 2.88/device2019-08: 1 reports for this device; peer average 2.25/device2019-09: 0 reports for this device; peer average 2.83/device2019-10: 0 reports for this device; peer average 2/device2019-11: 0 reports for this device; peer average 2.67/device2019-12: 0 reports for this device; peer average 3/device2020-01: 0 reports for this device; peer average 3.25/device2020-02: 0 reports for this device; peer average 3.5/device2020-03: 0 reports for this device; peer average 2.67/device2020-04: 0 reports for this device; peer average 2.25/device2020-05: 0 reports for this device; peer average 2/device2020-06: 0 reports for this device; peer average 2.2/device2020-07: 0 reports for this device; peer average 4.5/device2020-08: 0 reports for this device; peer average 3/device2020-09: 0 reports for this device; peer average 3.25/device2020-10: 0 reports for this device; peer average 3/device2020-11: 0 reports for this device; peer average 2.44/device2020-12: 0 reports for this device; peer average 3/device2021-01: 0 reports for this device; peer average 3/device2021-02: 0 reports for this device; peer average 5/device2021-03: 0 reports for this device; peer average 4.33/device2021-04: 0 reports for this device; peer average 3.14/device2021-05: 0 reports for this device; peer average 2.6/device2021-06: 0 reports for this device; peer average 3.6/device2021-07: 0 reports for this device; peer average 4/device2021-08: 0 reports for this device; peer average 2.6/device2021-09: 0 reports for this device; peer average 2.5/device2021-10: 0 reports for this device; peer average 4/device2021-11: 0 reports for this device; peer average 3/device2021-12: 0 reports for this device; peer average 2.2/device2022-01: 0 reports for this device; peer average 3/device2022-02: 1 reports for this device; peer average 2.82/device2022-03: 0 reports for this device; peer average 6/device2022-04: 0 reports for this device; peer average 3/device2022-05: 0 reports for this device; peer average 3.5/device2022-06: 0 reports for this device; peer average 2.78/device2022-07: 0 reports for this device; peer average 3.17/device2022-08: 0 reports for this device; peer average 3.67/device2022-09: 0 reports for this device; peer average 3.8/device2022-10: 0 reports for this device; peer average 2.67/device2022-11: 0 reports for this device; peer average 3.2/device2022-12: 0 reports for this device; peer average 3/device2023-01: 0 reports for this device; peer average 4/device2023-02: 0 reports for this device; peer average 2.6/device2023-03: 0 reports for this device; peer average 2.6/device2023-04: 0 reports for this device; peer average 4/device2023-05: 0 reports for this device; peer average 2.29/device2023-06: 0 reports for this device; peer average 2.75/device2023-07: 1 reports for this device; peer average 2.29/device2023-08: 0 reports for this device; peer average 2.6/device2023-09: 0 reports for this device; peer average 2.29/device2023-10: 0 reports for this device; peer average 4.25/device2023-11: 0 reports for this device; peer average 4.4/device2023-12: 1 reports for this device; peer average 2.25/device2024-01: 0 reports for this device; peer average 1.33/device2024-02: 1 reports for this device; peer average 3/device2024-03: 0 reports for this device; peer average 2.75/device2024-04: 0 reports for this device; peer average 3.5/device2024-05: 2 reports for this device; peer average 3.42/device2024-06: 0 reports for this device; peer average 3.4/device2024-07: 0 reports for this device; peer average 2.5/device2024-08: 0 reports for this device; peer average 3/device2024-09: 0 reports for this device; peer average 2.75/device2024-10: 0 reports for this device; peer average 1.67/device2024-11: 0 reports for this device; peer average 4.27/device2024-12: 0 reports for this device; peer average 2.33/device2025-01: 0 reports for this device; peer average 2.08/device2025-02: 0 reports for this device; peer average 2.5/device2025-03: 0 reports for this device; peer average 2.22/device2025-04: 3 reports for this device; peer average 3.25/device2025-05: 0 reports for this device; peer average 3.13/device2025-06: 0 reports for this device; peer average 3.56/device2025-07: 0 reports for this device; peer average 4.21/device2025-08: 0 reports for this device; peer average 3.5/device2025-09: 0 reports for this device; peer average 3.54/device2025-10: 0 reports for this device; peer average 2.84/device2025-11: 3 reports for this device; peer average 2.89/device2025-12: 0 reports for this device; peer average 2.18/device2026-01: 0 reports for this device; peer average 3.68/device2026-02: 0 reports for this device; peer average 4/device2026-03: 0 reports for this device; peer average 2.53/device2026-04: 0 reports for this device; peer average 2.88/device2026-05: 0 reports for this device; peer average 2.84/device2026-06: 0 reports for this device; peer average 5.37/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.5
2019-0211
2019-0302.75
2019-0403
2019-0502.67
2019-0602
2019-0702.88
2019-0812.25
2019-0902.83
2019-1002
2019-1102.67
2019-1203
2020-0103.25
2020-0203.5
2020-0302.67
2020-0402.25
2020-0502
2020-0602.2
2020-0704.5
2020-0803
2020-0903.25
2020-1003
2020-1102.44
2020-1203
2021-0103
2021-0205
2021-0304.33
2021-0403.14
2021-0502.6
2021-0603.6
2021-0704
2021-0802.6
2021-0902.5
2021-1004
2021-1103
2021-1202.2
2022-0103
2022-0212.82
2022-0306
2022-0403
2022-0503.5
2022-0602.78
2022-0703.17
2022-0803.67
2022-0903.8
2022-1002.67
2022-1103.2
2022-1203
2023-0104
2023-0202.6
2023-0302.6
2023-0404
2023-0502.29
2023-0602.75
2023-0712.29
2023-0802.6
2023-0902.29
2023-1004.25
2023-1104.4
2023-1212.25
2024-0101.33
2024-0213
2024-0302.75
2024-0403.5
2024-0523.42
2024-0603.4
2024-0702.5
2024-0803
2024-0902.75
2024-1001.67
2024-1104.27
2024-1202.33
2025-0102.08
2025-0202.5
2025-0302.22
2025-0433.25
2025-0503.13
2025-0603.56
2025-0704.21
2025-0803.5
2025-0903.54
2025-1002.84
2025-1132.89
2025-1202.18
2026-0103.68
2026-0204
2026-0302.53
2026-0402.88
2026-0502.84
2026-0605.37
This device (reports/month)Average device in NIM (reports/device/month)

Regulatory clearances

  • P050019 APPR 2025-09-19 (k number procode)
  • P050019 APPR 2024-11-19 (k number procode)
  • P050019 OK30 2024-03-27 (k number procode)
  • P050019 APPR 2024-03-08 (k number procode)
  • P050019 OK30 2023-08-10 (k number procode)
  • P050019 OK30 2023-06-14 (k number procode)
  • P050019 OK30 2023-03-10 (k number procode)
  • P050019 APPR 2023-02-01 (k number procode)
  • P050019 OK30 2022-11-28 (k number procode)
  • P050019 OK30 2022-03-24 (k number procode)
  • P050019 OK30 2021-12-10 (k number procode)
  • P050019 OK30 2021-11-15 (k number procode)
  • P050019 OK30 2019-07-25 (k number procode)
  • P050019 OK30 2018-03-13 (k number procode)
  • P050019 OK30 2018-02-22 (k number procode)
  • P050019 OK30 2017-07-03 (k number procode)
  • P050019 OK30 2016-12-14 (k number procode)
  • P050019 OK30 2016-08-10 (k number procode)
  • P050019 OK30 2016-03-17 (k number procode)
  • P050019 OK30 2015-12-17 (k number procode)

Manufacturer compliance record — BOSTON SCIENTIFIC CORPORATION

  • Warning Letter 2014-04-10 Boston Scientific Corporation
  • OAI 2025-04-07 Boston Scientific Corporation · 9 citations
  • OAI 2025-04-07 Boston Scientific Corporation · 9 citations
  • NAI 2025-03-18 Boston Scientific Corporation · 0 citations
  • NAI 2025-03-18 Boston Scientific Corporation · 0 citations
  • NAI 2024-12-06 Nalu Medical, Inc. · 0 citations
  • VAI 2024-11-26 Boston Scientific Corporation · 3 citations
  • VAI 2024-11-26 Boston Scientific Corporation · 3 citations
  • NAI 2024-06-13 Elutia Inc · 0 citations
  • VAI 2024-01-23 Silk Road Medical · 1 citations
  • NAI 2023-12-05 Valencia Technologies Corporation · 0 citations
  • VAI 2023-12-01 Corbin Clinical Resources, Llc · 1 citations
  • NAI 2023-08-01 Boston Scientific Corporation · 0 citations
  • NAI 2023-08-01 Boston Scientific Corporation · 0 citations
  • NAI 2023-04-05 Intera Oncology, Inc. · 0 citations
  • NAI 2022-07-28 Boston Scientific Corporation · 0 citations
  • NAI 2022-07-28 Boston Scientific Corporation · 0 citations
  • VAI 2022-06-02 Boston Scientific de Costa Rica SRL · 0 citations
  • NAI 2022-03-23 Axonics, Inc. · 0 citations
  • VAI 2021-11-17 Valencia Technologies Corporation · 1 citations
  • NAI 2021-10-29 Boston Scientific Corporation · 0 citations