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Boston Scientific Model SC-4318, Clik X Anchor recallZ-2404-2026 · Boston Scientific Neuromodulation Corporation · initiated Apr 29, 2026

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 Neuromodulation 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

Sterile anchors my lack sterility assurance.

FDA root cause category: Packaging process control

What the company is doing

On April 29, 2026, Boston Scientific issued a Urgent Medical Device Recall via mail. Boston Scientific ask consignees to take the following actions: 1. Do NOT use Affected Product (Table 1), remove affected product from your facility s inventory, and segregate the units in a secure place until they can be returned to Boston Scientific. 2 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. 3. Forward this notice to any healthcare professional from your organization for awareness and to any organization to which affected devices have been transferred. 4. Complete and return the enclosed Reply Verification Tracking Form per the enclosed instructions. 5. Return Affected Product.

Recall details

Recall number
Z-2404-2026
Status
Open, Classified
Initiated by the company
Apr 29, 2026
Posted by the FDA
Jun 11, 2026
Recalling firm
Boston Scientific Neuromodulation Corporation
Quantity
43 units
Product code
LGW
FDA submissions
P030017
Distribution
US Nationwide distribution in the states of MD, UT, FL, LA, SC, OK.

Product description

Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180

Code information (models, lots, serial numbers)

GTIN: 08714729905318/Lot # 35107836

Devices named in this recall

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

Other devices under the same FDA submission

93 devices cleared under P030017 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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