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Expo recallZ-1657-2024 · Boston Scientific Corporation · initiated Mar 21, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Boston Scientific Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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.

FDA root cause category: Under Investigation by firm

What the company is doing

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.

Recall details

Recall number
Z-1657-2024
Status
Open, Classified
Initiated by the company
Mar 21, 2024
Posted by the FDA
May 10, 2024
Recalling firm
Boston Scientific Corporation
Quantity
330 catheters
Product code
DQO
FDA submissions
K152605
Distribution
Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.

Product description

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 125CM (5PK), REF H749085262302; cardiac catheter

Code information (models, lots, serial numbers)

UDI/DI 08714729007562, Batch Numbers: 60449785, 60491507, 60537491

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 94240).

Sources and updates

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