Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator, electrical, implanted, for parkins

FDA device recall Z-2240-2026 · posted 2026-05-28 · Open, Classified

Recall details

Recalling firm

Medtronic Neuromodulation

Reason for recall

A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates.

Action taken

Medtronic issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 5/13/2026 via UPS 2 day mail. The notice described the issue and requested the following: Actions: " Identify and segregate affected products within your inventory. " Return all unused affected product(s) to Medtronic as described in the Consignee Confirmation Form. Your Medtronic Sales Representative can assist in returning any affected product. " Share this notice with all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. " Complete and return the consignee confirmation form even if you do not have unused inventory. For questions regarding this communication, please contact your Medtronic Representative or Technical Services at 1-800-707-0933.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

MHY

Quantity affected

275 units

Distribution

Worldwide distribution - US Nationwide and The countries of Austria, France, Germany, Italy, Japan, Latvia, Netherlands, Poland, Spain, Sweden, Switzerland, United Kingdom.

Date initiated

2026-05-13

Date posted

2026-05-28

Location

Minneapolis, MN