Device product
Guider Softip Guide Catheter 5F 90CM MULTI PURPOSE, Catalog number M003100630, cardiac guide catheter
Z-0016-2024
Product summary
- Event
- Event 92785
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 326 units
- Official record key
device-enforcement:Z-0016-2024
Official wording
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 information: GTIN 08714729283515, Lot/Batch Numbers: 25651754, 25651753, 25761245, 26059691, 26409982, 26599707, 27219434 ****recall letter has more lot numbers****
Distribution pattern: US Nationwide distribution in the state of Indiana.
Derived failure modes
-
Unknown
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.