Recall Z-2917-2026— Galt Medical Corporation

Name: FDA recall Z-2917-2026
Creator: U.S. Food and Drug Administration
Published: 2026-06-26

Class II · Ongoing

Class II FDA medical device recall by Galt Medical Corporation, initiated 2026-06-26. It names 2 FDA 510(k) clearances: K021990, K000737. Product: Boston Scientific Enhance Transcarotid/Peripheral Access Kit REF: SR-4F21G7D-MP (Kit-075-03) Sheath with Dilator , Stiffen Dilator, Nitinol Mandrel Wire w/ Radiopaque Tip [Au}, Needle, Extension Tube with Stopcock. Reason: Black depth markings may detach from the outer sheath of the coaxial dilator introducer component of transcarotid-peripheral access kits..

Recalling firm: Galt Medical Corporation
Classification: Class II
Status: Ongoing
Initiated: 2026-06-26
Firm location: Garland, TX, United States

510(k) clearances named in this recall

2 on FDA's record

K021990 — GALT MEDICAL GUIDEWIREGalt Medical Corp.·cleared 2002-07-18
K000737 — COAXIAL DILATOR SETXentek Medical, Inc.·cleared 2000-08-01

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 Enhance Transcarotid/Peripheral Access Kit REF: SR-4F21G7D-MP (Kit-075-03) Sheath with Dilator , Stiffen Dilator, Nitinol Mandrel Wire w/ Radiopaque Tip [Au}, Needle, Extension Tube with Stopcock

Reason for recall

Black depth markings may detach from the outer sheath of the coaxial dilator introducer component of transcarotid-peripheral access kits.

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