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Serious riskFDA DeviceClass I

Boston Scientific Infinion CX leads recalled for possible fracture

Boston Scientific is recalling Infinion CX lead kits used in its Spinal Cord Stimulator systems. The lead body may be exposed to stress at the anchor site, which may cause high impedance readings or lead fractures, possibly leading to inadequate stimulation and additional intervention, including lead removal and replacement. The recall covers 1,079 unused kits.

From the FDA notice · Read the official notice ↗ · All Boston Scientific recalls

What to do

  1. Set aside unused Infinion CX lead kits, model SC-2317-50 (UDI 08714729861614) and model SC-2317-70 (UDI 08714729861638).
  2. The notice doesn't specify a remedy; contact Boston Scientific Neuromodulation Corporation for instructions on the affected kits.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500; INFINION CX LEAD KIT, 70CM, Model: SC-2317-70, Material: M365SC2317700. part of the Boston Scientific Spinal Cord Stimulator (SCS) Systems.
Sold in
US: NY. OUS: Canada, Portugal, Spain, France, Netherlands, Great Britain, Italy, Israel, Serbia, Greece, Germany, United Arab Emirates, Ireland, Hungary, Czech Republic, Brazil, Colombia, Argentina
Made for
Adults (0 months and older)

Details

Units affected
1079
Illnesses reported
None reported
Manufactured in
25155 Rye Canyon Loop, Valencia, CA, United States
Classification
Class I
Recall number
Z-2879-2026

In the FDA's words

Description
INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500; INFINION CX LEAD KIT, 70CM, Model: SC-2317-70, Material: M365SC2317700. part of the Boston Scientific Spinal Cord Stimulator (SCS) Systems. Spinal cord stimulation system lead body may be exposed to stress at the anchor site. This may result in high impedance measurements or lead fractures, which may lead to inadequate stimulation, additional intervention, including lead explant and replacement. Model/UDI-DI: SC-2317-50/08714729861614, SC-2317-70/08714729861638. All unused products. Distribution: US: NY. OUS: Canada, Portugal, Spain, France, Netherlands, Great Britain, Italy, Israel, Serbia, Greece, Germany, United Arab Emirates, Ireland, Hungary, Czech Republic, Brazil, Colombia, Argentina Affected quantity: 1079
Hazard
Spinal cord stimulation system lead body may be exposed to stress at the anchor site. This may result in high impedance measurements or lead fractures, which may lead to inadequate stimulation, additional intervention, including lead explant and replacement.

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