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Axios recallZ-1029-2025 · Boston Scientific Corporation · initiated Dec 20, 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

Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.

FDA root cause category: Process control

What the company is doing

Boston Scientific issued Urgent Medical Device Removal - Immediate Action Required Letter via Fedex Priority Overnight on December 20, 2024 to US consignees. Letter states reason for recall, health risk and action to take: This removal affects only the products listed in Attachment 1. Immediately post this information in a visible location near the affected products to ensure this information is readily accessible to all handlers and users of the device. Share this notice with any health care professional within your organization and with any organization where the affected products may have been transferred. " If you are a distributor, this notification must be forwarded to your customers to ensure notification of this product removal is carried out to the end-user level. If you are a facility that has sent products to another hospital or a facility within your network, ensure this notification is forwarded to them. Contact your local Boston Scientific representative with any questions.

Recall details

Recall number
Z-1029-2025
Status
Open, Classified
Initiated by the company
Dec 20, 2024
Posted by the FDA
Jan 29, 2025
Recalling firm
Boston Scientific Corporation
Quantity
47 units
Product code
KNS
FDA submissions
K233318
Distribution
Nationwide including Puerto Rico Foreign: To be provided

Product description

AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553690

Code information (models, lots, serial numbers)

GTIN: 00191506008093 Lot Numbers: 33419782, 33477824, 34116467, 33419783, 33511487

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 96049).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page