Vectris(TM) Trial Screening Lead Kit for Spinal Cord Stimulation, Models: (a) 977D160 (b) 977D260 Product Usage: The Med

FDA device recall Z-2431-2018 · posted 2018-07-13 · Terminated

Recall details

Recalling firm

Medtronic Neuromodulation

Reason for recall

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.

Action taken

Beginning 25 May 2018, Medtronic sent a letter via mail to affected customers. The notification included the customer letter, confirmation form (reply form), and a list of affected product serial numbers. The letter informed customers of the recall, and provided instructions on the identification and return of affected products. The firm expanded the recall, notifying their consignees by letter on 07/13/2018. Customers with device related questions can contact Technical Services at 1-800-707-0933 weekdays 7am-6pm CT.

Root cause

Process control

Status

Terminated

Product code

LGW

Quantity affected

10,800 units

Distribution

Worldwide

Date initiated

2018-05-25

Date posted

2018-07-13

Date terminated

2020-12-11

Location

Minneapolis, MN