Z-0016-2024 Class II Ongoing
FDA device recall Z-0016-2024 was initiated by Boston Scientific Corporation on July 27, 2023 and is designated Class II. Reason for recall: 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 whi… The recall status is ongoing. Affected quantity: 326 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 11, 2023
- Initiation Date
- July 27, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 326 units
Product Description
Guider Softip Guide Catheter 5F 90CM MULTI PURPOSE, Catalog number M003100630, cardiac guide catheter
Reason for Recall
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.
Distribution Pattern
US Nationwide distribution in the state of Indiana.
Code Information
GTIN 08714729283515, Lot/Batch Numbers: 25651754, 25651753, 25761245, 26059691, 26409982, 26599707, 27219434 ****recall letter has more lot numbers****