Z-1582-2022 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- August 31, 2022
- Initiation Date
- August 9, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 184 devices (UPDATED)
Product Description
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 Pattern
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.
Code Information
UDI/DI 08714729202486, Lot/Batch 27339850, Use By 2021-05-18, and UPDATE: Lot/Batch 29308869, Use By 4/27/2025.