Z-0894-2013Class II

Advanced Neuromodulation Systems, Brio DBS System implantable neurostimulator, IPG or R-IPG, Model 6788...

Name: Z-0894-2013 Advanced Neuromodulation Systems, Brio DBS System implantable neurostimulator, IPG or R-IPG, Model 6788...
Creator: Advanced Neuromodulation Systems Inc.
Published: 2012-03-28
License: https://open.fda.gov/license/

Abbott Medical / initiated 2012-03-28 / Terminated / root cause: design

FDA source

Advanced Neuromodulation Systems Inc. began a recall of Advanced Neuromodulation Systems, Brio DBS System implantable neurostimulator, IPG or R-IPG, Model 6788 Implantable Pulse Generator on 2012-03-28. FDA classified it as Class II and gives the reason as "Unintended Fluid ingress into the device header has been shown". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0894-2013
Classification: Class II
Status: Terminated
Initiated: 2012-03-28
Posted: 2013-02-28
Terminated: 2013-08-15
Recalling firm: Abbott Medical
Product: Advanced Neuromodulation Systems, Brio DBS System implantable neurostimulator, IPG or R-IPG, Model 6788 Implantable Pulse Generator.
Product code: MHY Stimulator, Electrical, Implanted, For Parkinsonian Tremor
Reason for recall: Unintended Fluid ingress into the device header has been shown.
Root cause tag: design
FDA root cause: Device Design
Action: St. Jude Medical sent an Important Product Field Corrective Action Device Information letter dated March 28, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory for any unused product, isolate the affected product for return to St. Jude Medical. Their local representatiave would collect the unused inventory. Any unused product would be replaced with product once inventory becomes available. For patients with implanted product and no degradation of therapy, it is recommended dthat the devices not be unnecesssarily explanted. For patient with implanted product who experience diminished or loss of therapy customers were advised to follow the steps provided in the letter. Customers were asked to forward the notification to any institution in the event one or more patients or products could be potentially affected by this action. Customers wsere asked to maintain a record of thenotice along with the recommendations to ensure the effectiveness of the communication. For questions regarding this recall call 972-309-2154.
Quantity in commerce: 388 units
Distribution: Worldwide Distribution - 53 consignees out of the US.
Product codes and lots: Model number 6788. All lots manufactured prior to 03/16/2012 are being recalled.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0894-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0894-2013	Class II	Terminated	Voluntary: Firm initiated	2013-03-06	2013-02-28

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)