St — Class II medical device recall Z-2334-2018
Terminated recall by St Jude Medical Inc., reported 2018-07-11, distributed nationwide. The firm is advising physicians that exposure to sub-freezing temperatures during the supply chain process cau
| Recall number | Z-2334-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | St Jude Medical Inc., Sylmar, CA, United States |
| Recall initiated | 2018-04-16 |
| Classified | 2018-06-29 |
| Reported by FDA | 2018-07-11 |
| Terminated | 2021-02-04 |
| Distributed | Nationwide (US) |
| Quantity | 986 |
| UPC / GTIN / UDI-DI | 05415067027320 |
| Serial numbers | 3161789, 3168747, 3169502, 3169553, 3172363, 3175355, 3175364, 3175377, 3175385, 3175392, 3178901, 3178902, 3178909, 3178930, 3178945, 3178951, 3178957, 3178995, 3179103, 3179105, 3179113, 3179123, 3179143, 3179149, 3179177 and 475 more |
| Model numbers | DM3500 |
Product
St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.
Reason for recall
The firm is advising physicians that exposure to sub-freezing temperatures during the supply chain process caused a transient battery voltage drop for a small number of Confirm Rx Model DM3500 Insertable Cardiac Monitoring (ICM) devices. This drop is an expected and normal behavior for this battery chemistry, but causes an incorrect display of a low battery indicator even after the battery voltage returns to normal.
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-2334-2018. 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.