Z-1803-2024 Class II Ongoing
FDA device recall Z-1803-2024 was initiated by Medtronic Perfusion Systems on Mar 19, 2024 and is designated Class II. Reason for recall: Potential for unsealed sterile packing. The recall status is ongoing. Affected quantity: 1410 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 22, 2024
- Initiation Date
- Mar 19, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1410 units
Product Description
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
Reason for Recall
Potential for unsealed sterile packing.
Distribution Pattern
Worldwide distribution.
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1803-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026