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Recall Observatory FDA recall evidence

Device product

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK (SGL), REF H749085263001; cardiac catheter

Z-1665-2024

March 21, 2024

Class I

Product summary

Firm
Boston Scientific Corporation
Event
Event 94240
Status
Ongoing
Classification
Class I
Quantity
363 catheters
Official record key
device-enforcement:Z-1665-2024

Official wording

Reason: 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.

Code information: UDI/DI 08714729521501, Batch Numbers: 60443927, 60495422

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.