CLASS II Device recall · Reported 4 Apr 2018 · FDA Enforcement Report

Proclaim DRG Implantable Pulse Generator recalled by St. Jude Medical

St. Jude Medical is recalling Proclaim DRG Implantable Pulse Generator. The recall was initiated on 9 Mar 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 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

Quantity recalled17 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1170-2018
FDA event ID: 79560
Recalling firm: St. Jude Medical, Plano, TX
Classification: Class II
Status: Terminated
Recall initiated: 9 Mar 2018
FDA classified: 23 Mar 2018
Reported: 4 Apr 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

9 Mar 2018	Recall initiated by company
23 Mar 2018	Classified by FDA	+14 days
4 Apr 2018	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

Proclaim DRG Implantable Pulse Generator, Model Number 3664

Where it was distributed

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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