Device product
MINI STICK MAX 5F X 10 CM STD .018 SS/SS ECHO 2.75" PG -Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-754
Z-1338-2024
Product summary
- Event
- Event 94035
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1676 units
- Official record key
device-enforcement:Z-1338-2024
Official wording
Reason: Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case
Code information: UDI: 15051684022972 UPN: H965457541 Lot Number: Lot: 5784134 5787807 5787808 5787809 5787810 5789980 5790676 5800402 5803531
Distribution pattern: Worldwide distribution - US Nationwide and the countries of AT, CA, CH, CZ, ES, HK, KW, NL, NO, NZ, ZA.
Derived failure modes
-
Unknown
Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case