Device product
Guider Softip Guide Catheter 5F PRE-SHAPED 40 100CM, Catalog number M003101620, cardiac guide catheter
Z-0023-2024
Product summary
- Event
- Event 92785
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1170 units
- Official record key
device-enforcement:Z-0023-2024
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 08714729283539, Lot/Batch Numbers: 26409983, 26590809, 27450921, 27780468, 25715223, 25761249, 25964483, 25964484, 26138315, 26409984, 26891844, 27558598, 27780463, 28632343, 28737896
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.