Recall Z-2977-2026— Boston Scientific Corporation

Name: FDA recall Z-2977-2026
Creator: U.S. Food and Drug Administration
Published: 2026-07-09

Class I · Ongoing

Class I FDA medical device recall by Boston Scientific Corporation, initiated 2026-07-09. It names one FDA 510(k) clearance: K153485. Product: Boston Scientific ENROUTE Transcarotid Neuroprotection System, Material Number SR-200-NPS; Percutaneous catheter. Reason: Potential for arterial sheath tip separation or partial tip separation during use..

Recalling firm: Boston Scientific Corporation
Classification: Class I
Status: Ongoing
Initiated: 2026-07-09
Firm location: Maple Grove, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K153485 — ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc.·cleared 2016-03-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Boston Scientific ENROUTE Transcarotid Neuroprotection System, Material Number SR-200-NPS; Percutaneous catheter

Reason for recall

Potential for arterial sheath tip separation or partial tip separation during use.

Data sourced from openFDA. This site is unofficial and independent of the FDA.