Boston Scientific Corporation Recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F
Boston Scientific Corporation Recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Boston Scientific Corporation; Product: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR1 (5PK), REF H74908526842; cardiac catheter; Re
| Recalling firm | Boston Scientific Corporation |
|---|---|
| Product | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR1 (5PK), REF H74908526842; cardiac catheter |
| 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. |
| Classification | Class I (most serious — reasonable probability of serious health consequences or death) |
| Status | Ongoing |
| Distribution | Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions. |
| Recall initiated | 20240321 |
| Recall number | Z-1680-2024 |
| Category | device |
| State | MN |
| Country | United States |
$29/mo
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