FDA-Device2023-10-11Class II
Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, cardiac guide catheter
Boston Scientific Corporation
Hazard
Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.
Sold states
US Nationwide distribution in the state of Indiana.
Affected count
4426 units
Manufactured in
1 Scimed Pl, N/A, Maple Grove, MN, United States
Products
Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, cardiac guide catheter
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0010-2024Don't want to check this manually?
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