Recall Z-1673-2024
Boston Scientific Corporation · initiated March 21, 2024
Class I – dangerous or defective products that could cause serious health problems or death
Product
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H749085265022; cardiac catheter
Codes / lots: UDI/DI 08714729249429, Batch Numbers: 60447165, 60490140, 60490183
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-determined cause: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-1673-2024
- Initiated
- March 21, 2024
- Posted by FDA
- May 10, 2024
- Product code
- DQO – Catheter, Intravascular, Diagnostic
- Quantity
- 1950 catheters
- Distribution
- Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.
- Recalling firm
- Boston Scientific Corporation, Maple Grove, MN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1638-2024 Class I | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR3.5 (5PK), REF H74908526012…An increase in complaints related to an inability to advance the guidewire through the lumen of the device… | 03/21/2024Open, Classified |
| Z-1639-2024 Class I | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 (5PK), REF H74908526022…An increase in complaints related to an inability to advance the guidewire through the lumen of the device… | 03/21/2024Open, Classified |
| Z-1640-2024 Class I | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 (SGL), REF H74908526031…An increase in complaints related to an inability to advance the guidewire through the lumen of the device… | 03/21/2024Open, Classified |
| Z-1641-2024 Class I | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 (5PK), REF H74908526032…An increase in complaints related to an inability to advance the guidewire through the lumen of the device… | 03/21/2024Open, Classified |
| Z-1642-2024 Class I | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR6 (5PK), REF H74908526042…An increase in complaints related to an inability to advance the guidewire through the lumen of the device… | 03/21/2024Open, Classified |
| Z-1643-2024 Class I | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 MOD (5PK), REF…An increase in complaints related to an inability to advance the guidewire through the lumen of the device… | 03/21/2024Open, Classified |
| Z-1644-2024 Class I | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL3 (5PK), REF H749085261002…An increase in complaints related to an inability to advance the guidewire through the lumen of the device… | 03/21/2024Open, Classified |
| Z-1645-2024 Class I | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CAS1 (5PK), REF H749085261712…An increase in complaints related to an inability to advance the guidewire through the lumen of the device… | 03/21/2024Open, Classified |
| Z-1646-2024 Class I | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO KIMNY (5PK), REF…An increase in complaints related to an inability to advance the guidewire through the lumen of the device… | 03/21/2024Open, Classified |
| Z-1647-2024 Class I | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO RCB (5PK), REF H749085261902…An increase in complaints related to an inability to advance the guidewire through the lumen of the device… | 03/21/2024Open, Classified |
| Z-1648-2024 Class I | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO LCB (5PK), REF H749085261952…An increase in complaints related to an inability to advance the guidewire through the lumen of the device… | 03/21/2024Open, Classified |
| Z-1649-2024 Class I | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IM (5PK), REF H749085262012…An increase in complaints related to an inability to advance the guidewire through the lumen of the device… | 03/21/2024Open, Classified |
| Z-1650-2024 Class I | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IMT (5PK), REF H749085262022…An increase in complaints related to an inability to advance the guidewire through the lumen of the device… | 03/21/2024Open, Classified |
| Z-1651-2024 Class I | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IMC (5PK), REF H749085262032…An increase in complaints related to an inability to advance the guidewire through the lumen of the device… | 03/21/2024Open, Classified |
| Z-1652-2024 Class I | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL3 (5PK)REF H7490852620A2…An increase in complaints related to an inability to advance the guidewire through the lumen of the device… | 03/21/2024Open, Classified |
| Z-1653-2024 Class I | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL3.5 (5PK), REF H74908526212…An increase in complaints related to an inability to advance the guidewire through the lumen of the device… | 03/21/2024Open, Classified |
| Z-1654-2024 Class I | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4 125CM (5PK), REF…An increase in complaints related to an inability to advance the guidewire through the lumen of the device… | 03/21/2024Open, Classified |
| Z-1655-2024 Class I | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4 (5PK), REF H74908526222…An increase in complaints related to an inability to advance the guidewire through the lumen of the device… | 03/21/2024Open, Classified |
| Z-1656-2024 Class I | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 125CM (5PK), REF…An increase in complaints related to an inability to advance the guidewire through the lumen of the device… | 03/21/2024Open, Classified |
| Z-1657-2024 Class I | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 125CM (5PK), REF…An increase in complaints related to an inability to advance the guidewire through the lumen of the device… | 03/21/2024Open, Classified |
| Z-1658-2024 Class I | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4.5 (5PK), REF H74908526232…An increase in complaints related to an inability to advance the guidewire through the lumen of the device… | 03/21/2024Open, Classified |
| Z-1659-2024 Class I | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL5 125CM (5PK), REF…An increase in complaints related to an inability to advance the guidewire through the lumen of the device… | 03/21/2024Open, Classified |
| Z-1660-2024 Class I | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IM 125CM (5PK), REF…An increase in complaints related to an inability to advance the guidewire through the lumen of the device… | 03/21/2024Open, Classified |
| Z-1661-2024 Class I | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO TIG4 (5PK), REF H749085262502…An increase in complaints related to an inability to advance the guidewire through the lumen of the device… | 03/21/2024Open, Classified |
| Z-1662-2024 Class I | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL6 (5PK), REF H74908526252…An increase in complaints related to an inability to advance the guidewire through the lumen of the device… | 03/21/2024Open, Classified |
| Z-1663-2024 Class I | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO JIG3.5 (5PK), REF…An increase in complaints related to an inability to advance the guidewire through the lumen of the device… | 03/21/2024Open, Classified |
| Z-1664-2024 Class I | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO JIG4 (5PK), REF H749085262532…An increase in complaints related to an inability to advance the guidewire through the lumen of the device… | 03/21/2024Open, Classified |
| Z-1665-2024 Class I | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK (SGL), REF…An increase in complaints related to an inability to advance the guidewire through the lumen of the device… | 03/21/2024Open, Classified |
| Z-1666-2024 Class I | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK (5PKX3), REF…An increase in complaints related to an inability to advance the guidewire through the lumen of the device… | 03/21/2024Open, Classified |
| Z-1667-2024 Class I | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (SGL), REF…An increase in complaints related to an inability to advance the guidewire through the lumen of the device… | 03/21/2024Open, Classified |