Z-1582-2022 Class II Ongoing
FDA device recall Z-1582-2022 was initiated by Boston Scientific Corporation on Aug 9, 2022 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 184 devices (UPDATED).
Recall Details
- Product Type
- Devices
- Report Date
- Aug 31, 2022
- Initiation Date
- Aug 9, 2022
- 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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1582-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026