St. Jude Medical Confirm Rx Insertable Cardiac Monitor Recall
St. Jude Medical is recalling 986 Confirm Rx Insertable Cardiac Monitors because exposure to sub-freezing temperatures caused a transient battery voltage drop, resulting in an incorrect low battery indicator display.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves an incorrect display indicator rather than a direct physiological failure or reported injury, fitting the criteria for a moderate severity recall involving a functional defect without immediate reported harm.
Plain-English summary
St. Jude Medical Inc. is recalling 986 units of the Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500. The recall was initiated after the firm advised physicians that exposure to sub-freezing temperatures during the supply chain process caused a transient battery voltage drop in a small number of these devices.
The battery voltage drop is described as an expected and normal behavior for this specific battery chemistry. However, this event causes the device to incorrectly display a low battery indicator, even after the battery voltage returns to normal levels. The affected devices were distributed nationwide across numerous U.S. states and the District of Columbia.
Physicians are advised of this issue regarding the affected serial numbers. Patients with these specific devices should consult their healthcare providers for guidance on the incorrect battery indicator display.
The recalled product
- 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
- Manufacturer
- St Jude Medical Inc.
- Category
- Medical Device — Cardiac Monitor
- Affected units
- 986
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI # 05415067027320
Distribution
Part of a larger recall action
This product is one of 2 recalled by St Jude Medical Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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