FDA Device recall Z-2334-2018
St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring and…
- FDA Device
- Class II
- terminated
- Published 2018-07-11
On 2018-07-11 the FDA classified a Class II recall of St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring and… by St Jude Medical, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2334-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-04-16 |
| Published | 2018-07-11 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | St Jude Medical |
| Distribution | US |
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
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.
Identifiers
| code_info | UDI # 05415067027320, serial #: 3183655 3184443 3184389 3199068 3196286 3184694 3190294 3181655 3198025 31907…UDI # 05415067027320, serial #: 3183655 3184443 3184389 3199068 3196286 3184694 3190294 3181655 3198025 3190799 3194537 3180006 3192949 3186903 3187101 3196843 3196904 3192584 3197571 3200146 3196834 3199504 3196786 3196805 3195788 3190818 3188329 3201060 3199511 3181484 3198003 3204372 3204525 3204636 3180578 3192047 3197501 3196979 3204026 3190151 3197910 3199061 3187666 3187623 3187958 3199534 3187579 3183988 3191662 3191694 3189471 3189447 3193462 3184495 3182230 3190806 3198544 3195797 3193022 3192891 3186926 3200949 3193007 3199057 3202523 3197153 3193232 3190810 3172363 3190533 3181685 3200755 3195794 3194101 3184565 3198525 3198218 3179589 3193169 3198440 3200149 3182632 3192996 3191110 3190276 3187652 3192050 3193294 3198473 3193374 3182618 3192025 3197500 3195597 3181067 3202827 3180032 3184390 3191088 3199082 3193190 3179542 3196379 3191707 3192522 3192553 3192345 3197 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2334-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.