Proclaim DRG Implantable Pulse Generator recall
Proclaim DRG Implantable Pulse Generator, Model Number 3664
Why was Proclaim DRG Implantable Pulse Generator recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models 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
- Product
- Proclaim DRG Implantable Pulse Generator, Model Number 3664
- Recalling firm
- St. Jude Medical, Inc.
- Quantity
- 17 units
- Distribution
- US
- Recall date
- April 4, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)