Vectris SureScan MRI Leads and Vectris Trialing Leads (2018-05-24)

Starting date:

May 24, 2018

Posting date:

June 14, 2018

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-67036

• 
  Reason
• 
  Affected products

Affected products

A. Vectris SureScan MRI Leads

B. Vectris Trialing Leads

Reason

Medtronic is voluntarily recalling specific production lots of the Vectris Trial Screening Lead Kits (models 977d160 and 977d260) and the Vectris Surescan Lead Kits (models 977a160, 977a175, 977a190, 977a260, 977a275 and 977a290). These lead kits are used in Spinal Cord Stimulation (SCS) pain therapy surgical procedures. The issue affects a subset of lots with a "use by" date beginning 2021-10-31 through 2022-03-08. This voluntary recall is being conducted due to the curved tip introducer needle which is included in the kit, to have a potential manufacturing defect. This could result in difficulty advancing or withdrawing the Vectris lead through the curved tip introducer needle.

Affected products