FDA Classifies Boston Scientific Infinion CX Lead Removal as Class I Recall
FDA has classified the recall of Boston Scientific Infinion CX Leads as Class I. The manufacturer is removing unused leads due to mechanical stress at anchor sites that may cause lead fractures and inadequate stimulation.
Decision support
Decision summary
Official recall information is separated from MedTech Current editorial analysis.
Official recall information
What happened
Boston Scientific is recalling and removing unused Infinion CX Leads from the market after identifying that the lead body may experience mechanical stress at the anchor site. The FDA has classified the action as a Class I recall. According to the FDA communication, mechanical stress at the anchor location can cause abnormal impedance measurements or lead fractures, which may result in a loss of adequate neurostimulation therapy and require surgical intervention to explant and replace the damaged lead. As of May 27, 2026, Boston Scientific reported 1,081 serious injuries and zero deaths related to this issue. The recall involves removing unused devices from inventory and does not require explantation of devices that are already implanted and functioning.
MedTech Current analysis
Why it matters
Mechanical stress at anchor points can compromise neurostimulation therapy and necessitate revision surgeries for lead explantation and replacement. While patients with existing implants require only routine follow-up, healthcare facilities must immediately segregate and return all unused inventory.
Official recall information
Official actions
According to Boston Scientific's customer notification:
- Immediately stop further use and distribution of affected Infinion CX Lead kits.
- Quarantine and segregate all affected products in inventory.
- Return all unused affected product to Boston Scientific.
- Share the recall notice with all clinical staff within the facility who utilize the system, as well as any organizations to which these systems were transferred.
- Maintain routine clinical follow-up for patients with existing implants; no additional monitoring is recommended.
Detailed recall information
Detailed sourced information from the published Recall Brief follows.
What changed
Boston Scientific is recalling and removing unused Infinion CX Leads from the market after identifying that the lead body may experience mechanical stress at the anchor site. The FDA has classified the action as a Class I recall.
According to the FDA communication, mechanical stress at the anchor location can cause abnormal impedance measurements or lead fractures. These issues can result in a loss of adequate neurostimulation therapy and may require surgical intervention to explant and replace the damaged lead.
As of May 27, 2026, Boston Scientific reported 1,081 serious injuries and zero deaths related to this issue. The recall involves removing unused devices from inventory and does not require the explantation of devices that are already implanted and functioning.
Who and what are affected
The Infinion CX Lead is a component of a Spinal Cord Stimulator (SCS) System used to manage chronic pain in the back and limbs.
The recall specifically affects two lead kit configurations:
| Device Name | Model | Material Number | GTIN |
|---|---|---|---|
| Infinion CX Lead Kit, 50 cm | SC-2317-50 | M365SC2317500 | 08714729861614 |
| Infinion CX Lead Kit, 70 cm | SC-2317-70 | M365SC2317700 | 08714729861638 |
The action applies only to unused inventory in healthcare facilities and distribution channels.
What affected organizations should do
Healthcare facilities and clinical users
According to Boston Scientific’s customer notification:
- Immediately stop further use and distribution of affected Infinion CX Lead kits.
- Quarantine and segregate all affected products in inventory.
- Return all unused affected product to Boston Scientific.
- Share the recall notice with all clinical staff within the facility who utilize the system, as well as any organizations to which these systems were transferred.
- Maintain routine clinical follow-up for patients with existing implants; no additional monitoring is recommended.