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Open, Classified

Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002; Stimulator, electrical, implanted, for parkinsonian tremor

FDA Recall Z-2241-2026 · Posted 2026-05-28

Recalling FirmMedtronic Neuromodulation
Recall StatusOpen, Classified
Product CodeMHY
Date Initiated2026-05-13
Product Quantity31 units

Reason for Recall

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

Firm Action

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

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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