Proclaim DRG Implantable Pulse Generator — Class II medical device recall Z-1170-2018
Terminated recall by St. Jude Medical, Inc., reported 2018-04-04. The firm received complaints of error messages that occurred during routine impedance checks on Proclaim DRG I
| Recall number | Z-1170-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | St. Jude Medical, Inc., Plano, TX, United States |
| Recall initiated | 2018-03-09 |
| Classified | 2018-03-23 |
| Reported by FDA | 2018-04-04 |
| Terminated | 2020-11-03 |
| Quantity | 17 units |
| Lot numbers | 6210849, 6210852, 6263128, 6268723, 6278155, 6499208 |
| Serial numbers | AUV770.1, AVA214.1, AVA560.1, AVA622.1, AVA922.1, AVB119.1, AVD400.1, AVD426.1, AVD431.1, AVE633.1, AVK678.1, AVK896.1, AVL027.1, AVM174.1, AVN837.1, AVW805.1 |
| Model numbers | 3664 |
Product
Proclaim DRG Implantable Pulse Generator, Model Number 3664
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1170-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.