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Boston Scientific Corporation recalls Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Catheter, REF H965100440
Recalled August 31, 2022 · FDA recall Z-1582-2022 · Boston Scientific
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. · FDA Class II
Units
184 devices (UPDATED)
Sold at
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.
Description
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.
Product
Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Catheter, REF H965100440
Manufacturer(s)
Boston Scientific Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →