FDA recall Z-1582-2022

Product

Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Catheter, REF H965100440

Reason for recall

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.

Distribution

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.

Key facts

Status

Ongoing

Initiation date

2022-08-09

Report date

2022-08-31

Voluntary/Mandated

Voluntary: Firm initiated

Location

Maple Grove, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1582-2022