St. Jude Medical, Inc.: Medical Device Recall in 2018 - (Recall #: Z-1170-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Proclaim DRG Implantable Pulse Generator, Model Number 3664

Product Classification:

Class II

Date Initiated: March 9, 2018

Date Posted: April 4, 2018

Recall Number: Z-1170-2018

Event ID: 79560

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.

Status: Terminated

Product Quantity: 17 units

Code Information:

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

Distribution Pattern:

Voluntary or Mandated:

Voluntary: Firm initiated