Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 MOD (5PK), REF H74908526052; cardiac catheter
Reported: May 22, 2024 Initiated: March 21, 2024 #Z-1643-2024
Product Description
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 MOD (5PK), REF H74908526052; 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.
Details
- Recalling Firm
- Boston Scientific Corporation
- Units Affected
- 385 catheters
- Distribution
- Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.
- Location
- Maple Grove, MN
Frequently Asked Questions
What product was recalled? ▼
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 MOD (5PK), REF H74908526052; cardiac catheter. Recalled by Boston Scientific Corporation. Units affected: 385 catheters.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 22, 2024. Severity: Critical. Recall number: Z-1643-2024.
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