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
- Company
- Medtronic Perfusion Systems
- Recall Initiated
- March 19, 2024
- Posted
- May 10, 2024
- Recall Number
- Z-1803-2024
- Quantity
- 1410 units
- Firm Location
- Brooklyn Park, MN
Reason for Recall
Potential for unsealed sterile packing.
Distribution
Worldwide distribution.
Lot / Code Info
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
Root Cause
Process control
Action Taken
Medtronic issued an Urgent Medical Device Recall notice to its consignees on 03/19/2024 via letter (UPS). The notice explained the issue, potential risk, and requested the consignee identify and return the product. Consignee was directed to forward the notice to all affected parties. For questions, the consignee was directed to contact their Medtronic field representative.