Device product
Guider Softip Guide Catheter 8F 100CM MULTI PURPOSE, Catalog number M003101480, cardiac guide catheter
Z-0022-2024
Product summary
- Event
- Event 92785
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3777 units
- Official record key
device-enforcement:Z-0022-2024
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 08714729244356, Lot/Batch Numbers: 26277188, 26599713, 26709826, 27170547, 27203658, 27339851, 27535146, 27728492, 27902047, 28320867, 28564218, 28616007, 28632345, 26138706, 26277189, 26411756, 26411757, 26599714, 26599715, 26709827, 26746119, 26746120, 26891840, 26891841, 26984254, 27254933, 27379026, 27379027, 27558597, 27645561, 27782880, 27980980, 27988374, 28320864, 28320865, 28320866, 28564219, 28564380, 28584613, 28616008, 28632340, 28632341, 28632342, 29513117
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.