Medtronic Neuromodulation: Medical Device Recall in 2016 - (Recall #: Z-2645-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

DBS Pocket Adaptor, Model 64001 and Model 64002. The Medtronic Models 64001 (1x4) and 64002 (2x4) Pocket Adaptors can be used as a part of a neurostimulation system for deep brain stimulation. The pocket adaptor is intended to be implanted with the new replacement neurostimulator in the same pocket used for the explanted neurostimulator. Implanting in the same neurostimulator pocket allows for a single-incision procedure.

Product Classification:

Class II

Date Initiated: June 23, 2016

Date Posted: August 31, 2016

Recall Number: Z-2645-2016

Event ID: 74552

Reason for Recall:

Due to the potential for pocket adaptor conductor wire fractures involving DBS Pocket Adaptor Model 64001 and Model 64002, a safety notification was sent to healthcare professionals to reinforce device specific labeling for the handling of pocket adaptors and system integrity checking during implant procedures.

Status: Terminated

Product Quantity: 7,542 in the US and 12,999 outside the US.

Code Information:

Notification is not lot specific.

Distribution Pattern:

Worldwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated