Medtronic Perfusion Systems 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 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Medtronic Perfusion Systems
Lot Codes / Batch Numbers
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
Products Sold
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
Medtronic Perfusion Systems is recalling Medtronic Intracoronary Shunts: a) ClearView 1.00 mm Intracoronary Shunt, Model Numbers: 31100; due to Potential for unsealed sterile packing.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential for unsealed sterile packing.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026