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Open, Classified

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H749085263012; cardiac catheter

FDA Recall Z-1668-2024 · Posted 2024-05-10

Recalling FirmBoston Scientific Corporation
Recall StatusOpen, Classified
Product CodeDQO
Date Initiated2024-03-21
Product Quantity86898 catheters

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.

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.

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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