Device product
Medtronic Intracoronary Shunts: a) ClearView¿ 1.00 mm Intracoronary Shunt, Model Numbers: 31100; b) ClearView¿ 1.25 mm Intracoronary Shunt, Model Numbers: 31125; c) ClearView¿ 2.00 mm Intracoronary Shunt, Model Numbers: 31200
Z-1803-2024
Product summary
- Event
- Event 94274
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1410 units
- Official record key
device-enforcement:Z-1803-2024
Official wording
Reason: Potential for unsealed sterile packing.
Code information: a) Model Numbers: 31100, GTIN 20885074257116, Lot Numbers: 2023081208; b) Model Numbers: 31125, GTIN 20885074257406, lot Numbers: 2023041455, 202306C205; c) Model Numbers: 31200, GTIN 00885074257433, Lot Numbers: 2023040542; c) Model Numbers: 31200, GTIN 20885074257437, Lot Numbers: 2023040542, 2023041002, 202305C173
Distribution pattern: Worldwide distribution.
Derived failure modes
-
Unknown
Potential for unsealed sterile packing.