Health product recall

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