Device product
Guider Softip Guide Catheter 7F PRE-SHAPED 40 100CM, Catalog number M003101430, cardiac guide catheter
Z-0018-2024
Product summary
- Event
- Event 92785
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1004 units
- Official record key
device-enforcement:Z-0018-2024
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 08714729244301, Lot/Batch Numbers: 27241919, 27516638, 27780467, 27780470, 28065090, 26138318, 26891812, 28676781, 28595471, 28676782, 28886804, 28910751
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.