510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Z-1803-2024Class II

Medtronic Intracoronary Shunts: a) ClearView 1.00 mm Intracoronary Shunt, Model Numbers: 31100; b) ClearView...

Medtronic Perfusion Systems / initiated 2024-03-19 / Open, Classified / root cause: manufacturing process
FDA source (opens on fda.gov)

Medtronic Perfusion Systems began a recall of Medtronic Intracoronary Shunts: a) ClearView 1.00 mm Intracoronary Shunt, Model Numbers: 31100; b) ClearView 1.25 mm Intracoronary Shunt, Model Numbers: 31125... on . FDA classified it as Class II and gives the reason as "Potential for unsealed sterile packing". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-1803-2024
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
Medtronic Perfusion Systems
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
Product code
DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Reason for recall
Potential for unsealed sterile packing.
Root cause tag
manufacturing process
FDA root cause
Process control
Action
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.
Quantity in commerce
1410 units
Distribution
Worldwide distribution.
Product codes and lots
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

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1803-2024
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1793-2024Class IIOngoingVoluntary: Firm initiated
Z-1794-2024Class IIOngoingVoluntary: Firm initiated
Z-1795-2024Class IIOngoingVoluntary: Firm initiated
Z-1796-2024Class IIOngoingVoluntary: Firm initiated
Z-1797-2024Class IIOngoingVoluntary: Firm initiated
Z-1798-2024Class IIOngoingVoluntary: Firm initiated
Z-1799-2024Class IIOngoingVoluntary: Firm initiated
Z-1800-2024Class IIOngoingVoluntary: Firm initiated
Z-1801-2024Class IIOngoingVoluntary: Firm initiated
Z-1802-2024Class IIOngoingVoluntary: Firm initiated
Z-1803-2024Class IIOngoingVoluntary: Firm initiated
Z-1804-2024Class IIOngoingVoluntary: Firm initiated
Z-1805-2024Class IIOngoingVoluntary: Firm initiated