Z-1170-2018Class II

Proclaim DRG Implantable Pulse Generator, Model Number 3664

Name: Z-1170-2018 Proclaim DRG Implantable Pulse Generator, Model Number 3664
Creator: St. Jude Medical, Inc.
Published: 2018-03-09
License: https://open.fda.gov/license/

Abbott Medical / initiated 2018-03-09 / Terminated / root cause: software

FDA source

St. Jude Medical, Inc. began a recall of Proclaim DRG Implantable Pulse Generator, Model Number 3664 on 2018-03-09. FDA classified it as Class II and gives the reason as "The firm received complaints of error messages that occurred during routine impedance checks on Proclaim DRG IPGs, model 3664. Some complaints were also associated with transient over stimulation which created...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1170-2018
Classification: Class II
Status: Terminated
Initiated: 2018-03-09
Posted: 2018-03-23
Terminated: 2020-11-03
Recalling firm: Abbott Medical
Product: Proclaim DRG Implantable Pulse Generator, Model Number 3664
Product code: PMP Dorsal Root Ganglion Stimulator For Pain Relief
Reason for recall: The firm received complaints of error messages that occurred during routine impedance checks on Proclaim DRG IPGs, model 3664. Some complaints were also associated with transient over stimulation which created discomfort for the patients.
Root cause tag: software
FDA root cause: Software change control
Action: Notification material in the form of a Customer Letter was hand-delivered to two consignees in the US beginning 09 Mar 2018. The Physician Letter was hand-delivered to impacted implanting physicians, beginning 14 Mar 2018. A Patient Letter was delivered via certified mailing to all active implanted patients in the US, beginning 14 Mar 2018.
Quantity in commerce: 17 units
Distribution: US
Product codes and lots: Lot Number 6210849 Serial Number AVM174.1 Lot Number 6210852 Serial Numbers: AVA560.1, AVA214.1, AVL027.1 Lot Number 6499208 Serial Numbers: AVD426.1, AVA922.1 Lot Number 6263128 Serial Numbers: AVB119.1, AVD400.1, AVA622.1, AVD431.1, AVE633.1, AVK678.1, AVN837.1 Lot Number 6268723 Serial Numbers: AUV770.1, AVW805.1 Lot Number 6278155 Serial Number AVK896.1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1170-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1170-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-23

Product code PMP

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)