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
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
A. Vectris SureScan MRI Leads
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
977A160
977A175
977A190
977A260
977A275
977A290
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway
Minneapolis
55432
Minnesota
UNITED STATES
B. Vectris Trialing Leads
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
977D160
977D260
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway
Minneapolis
55432
Minnesota
UNITED STATES