FDA Enforcement
Class II
Ongoing
Guider Softip Guide Catheter 7F 100CM MULTI PURPOSE, Catalog number M003101470, cardiac guide catheter
Recall: Z-0021-2024
·
Reported October 11, 2023
Enforcement
- Recall Number
- Z-0021-2024
- Event ID
- 92785
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Boston Scientific Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 11, 2023
- Initiation Date
- July 27, 2023
- Classification Date
- October 3, 2023
- Address
- 1 Scimed Pl, N/A, Maple Grove, MN, 55311-1565, United States
Description
Guider Softip Guide Catheter 7F 100CM MULTI PURPOSE, Catalog number M003101470, cardiac guide catheter
Reason
Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.
Code Info
GTIN 08714729244349, Lot/Batch Numbers: 26746117, 26891819, 27121009, 27435625, 26411755, 26746118, 27435626, 27444224, 27558596 ****letter has more lot numbers than spreadsheet*****
Distribution
US Nationwide distribution in the state of Indiana.
Quantity
828 units