Z-2645-2016 Class II Terminated
FDA device recall Z-2645-2016 was initiated by Medtronic Neuromodulation on Jun 23, 2016 and is designated Class II. 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… The recall status is terminated (terminated Sep 21, 2017). Affected quantity: 7,542 in the US and 12,999 outside the US.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 31, 2016
- Initiation Date
- Jun 23, 2016
- Termination Date
- Sep 21, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7,542 in the US and 12,999 outside the US.
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.
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.
Distribution Pattern
Worldwide Distribution.
Code Information
Notification is not lot specific.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2645-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026