Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1651-2024Class I

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IMC (5PK), REF H749085262032; cardiac catheter

Boston Scientific Corporation / initiated 2024-03-21 / Open, Classified

Boston Scientific Corporation began a recall of Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IMC (5PK), REF H749085262032; cardiac catheter on . FDA classified it as Class I and gives the reason as "An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material...". As of , the recall status on record is Open, Classified.

Recall record

Recall number
Z-1651-2024
Classification
Class I
Status
Open, Classified
Initiated
Posted
Recalling firm
Boston Scientific Corporation
Product
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IMC (5PK), REF H749085262032; cardiac catheter
Product code
DQO Catheter, Intravascular, Diagnostic
Reason for recall
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
FDA root cause
Under Investigation by firm
Action
Boston Scientific issued an Urgent Medical Device Removal notice to its consignees on 03/21/2024 via overnight delivery. The notice explained the issue, the potential risk, and requested the removal of the affected products. Distributors were directed to notify their consignees.
Quantity in commerce
1170 catheters
Distribution
Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.
Product codes and lots
UDI/DI 08714729249214, Batch Numbers: 60448987, 60467091, 60476275, 60486323, 60535894

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1651-2024
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1638-2024Class IOngoingVoluntary: Firm initiated
Z-1639-2024Class IOngoingVoluntary: Firm initiated
Z-1640-2024Class IOngoingVoluntary: Firm initiated
Z-1641-2024Class IOngoingVoluntary: Firm initiated
Z-1642-2024Class IOngoingVoluntary: Firm initiated
Z-1643-2024Class IOngoingVoluntary: Firm initiated
Z-1644-2024Class IOngoingVoluntary: Firm initiated
Z-1645-2024Class IOngoingVoluntary: Firm initiated
Z-1646-2024Class IOngoingVoluntary: Firm initiated
Z-1647-2024Class IOngoingVoluntary: Firm initiated
Z-1648-2024Class IOngoingVoluntary: Firm initiated
Z-1649-2024Class IOngoingVoluntary: Firm initiated
Z-1650-2024Class IOngoingVoluntary: Firm initiated
Z-1651-2024Class IOngoingVoluntary: Firm initiated
Z-1652-2024Class IOngoingVoluntary: Firm initiated
Z-1653-2024Class IOngoingVoluntary: Firm initiated
Z-1654-2024Class IOngoingVoluntary: Firm initiated
Z-1655-2024Class IOngoingVoluntary: Firm initiated
Z-1656-2024Class IOngoingVoluntary: Firm initiated
Z-1657-2024Class IOngoingVoluntary: Firm initiated
Z-1658-2024Class IOngoingVoluntary: Firm initiated
Z-1659-2024Class IOngoingVoluntary: Firm initiated
Z-1660-2024Class IOngoingVoluntary: Firm initiated
Z-1661-2024Class IOngoingVoluntary: Firm initiated
Z-1662-2024Class IOngoingVoluntary: Firm initiated
Z-1663-2024Class IOngoingVoluntary: Firm initiated
Z-1664-2024Class IOngoingVoluntary: Firm initiated
Z-1665-2024Class IOngoingVoluntary: Firm initiated
Z-1666-2024Class IOngoingVoluntary: Firm initiated
Z-1667-2024Class IOngoingVoluntary: Firm initiated
Z-1668-2024Class IOngoingVoluntary: Firm initiated
Z-1669-2024Class IOngoingVoluntary: Firm initiated
Z-1670-2024Class IOngoingVoluntary: Firm initiated
Z-1671-2024Class IOngoingVoluntary: Firm initiated
Z-1672-2024Class IOngoingVoluntary: Firm initiated
Z-1673-2024Class IOngoingVoluntary: Firm initiated
Z-1674-2024Class IOngoingVoluntary: Firm initiated
Z-1675-2024Class IOngoingVoluntary: Firm initiated
Z-1676-2024Class IOngoingVoluntary: Firm initiated
Z-1677-2024Class IOngoingVoluntary: Firm initiated
Z-1678-2024Class IOngoingVoluntary: Firm initiated
Z-1679-2024Class IOngoingVoluntary: Firm initiated
Z-1680-2024Class IOngoingVoluntary: Firm initiated
Z-1681-2024Class IOngoingVoluntary: Firm initiated
Z-1682-2024Class IOngoingVoluntary: Firm initiated
Z-1683-2024Class IOngoingVoluntary: Firm initiated
Z-1684-2024Class IOngoingVoluntary: Firm initiated
Z-1685-2024Class IOngoingVoluntary: Firm initiated