Device product
Guider Softip Guide Catheter 5F PRE-SHAPED 40 90CM, Catalog number M003100620, cardiac guide catheter
Z-0015-2024
Product summary
- Event
- Event 92785
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1086 units
- Official record key
device-enforcement:Z-0015-2024
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 08714729283508, Lot/Batch Numbers: 26277195, 26891778, 25715235, 25715236, 25761247, 25761248, 26059690, 26277194, 26599706, 27170548, 27444248, 27516585, 28057178, 28584686, 28595475, 28811944
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.