FDA-Device2022-08-31Class II
Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Catheter, REF H965100440
Boston Scientific Corporation
Hazard
The impacted products were distributed with an MPXF tip curve shape instead of the 40XF tip curve shape for the Guider/40XF/8FR/90CM guide catheter.
Sold states
International distribution in the countries of Greece, France, Germany, Italy, Brazil and South Korea. UPDATE: The devices were also distributed to Russia. There was no U.S. distribution.
Affected count
184 devices (UPDATED)
Manufactured in
1 Scimed Pl, Maple Grove, MN, United States
Products
Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Catheter, REF H965100440
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1582-2022Don't want to check this manually?
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