Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 125CM (5PK), REF H749085262252; cardiac catheter
Boston Scientific Corporation began a recall of Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 125CM (5PK), REF H749085262252; 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-1656-2024
- Classification
- Class I
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Boston Scientific Corporation
- Product
- Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 125CM (5PK), REF H749085262252; 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
- 5435 catheters
- Distribution
- Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.
- Product codes and lots
- UDI/DI 08714729192817, Batch Numbers: 60430691, 60447156, 60463406, 60488300, 60493468, 60537513
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1638-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1639-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1640-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1641-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1642-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1643-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1644-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1645-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1646-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1647-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1648-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1649-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1650-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1651-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1652-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1653-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1654-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1655-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1656-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1657-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1658-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1659-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1660-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1661-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1662-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1663-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1664-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1665-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1666-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1667-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1668-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1669-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1670-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1671-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1672-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1673-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1674-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1675-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1676-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1677-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1678-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1679-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1680-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1681-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1682-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1683-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1684-2024 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1685-2024 | Class I | Ongoing | Voluntary: Firm initiated |
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