Z-2645-2016Class II

DBS Pocket Adaptor, Model 64001 and Model 64002. The Medtronic Models 64001 (1x4) and 64002 (2x4) Pocket...

Name: Z-2645-2016 DBS Pocket Adaptor, Model 64001 and Model 64002. The Medtronic Models 64001 (1x4) and 64002 (2x4) Pocket...
Creator: Medtronic Neuromodulation
Published: 2016-06-23
License: https://open.fda.gov/license/

Medtronic Neuromodulation / initiated 2016-06-23 / Terminated / root cause: manufacturing process

FDA source

Medtronic Neuromodulation began a recall of 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... on 2016-06-23. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2645-2016
Classification: Class II
Status: Terminated
Initiated: 2016-06-23
Posted: 2016-08-24
Terminated: 2017-09-21
Recalling firm: Medtronic Neuromodulation
Product: 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 code: MHY Stimulator, Electrical, Implanted, For Parkinsonian Tremor
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Consignees were sent on 6/23/2016 a "Medical Device Safety Notification," dated June 2016. The letter was addressed to Healthcare Professional. The letter described "Background" information on the problem and product involved in the recall. It also provided "Recommendations" which included "Implanting the pocket adaptor with the neurostimulator" and "Checking system integrity". For questions contact Medtronic Neuromodulation Technical Services at 1-800-707-0933 weekdays 7 am - 6pm CST.
Quantity in commerce: 7,542 in the US and 12,999 outside the US.
Distribution: Worldwide Distribution.
Product codes and lots: Notification is not lot specific.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2645-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2645-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-24

Product code MHY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)