St. Jude Medical Recalls Confirm Rx Insertable Cardiac Monitors
St. Jude Medical is recalling 2,906 Confirm Rx Insertable Cardiac Monitors because a software defect caused inappropriate low battery indicators.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a risk-of-harm product (cardiac monitor) where the defect (false low battery indicator) could lead to missed arrhythmia data, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
St. Jude Medical, Cardiac Rhythm Management Division, is recalling 2,906 units of the Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500. The recall involves the Merlin PCS Programmer software model 3330, version 24.0.1 rev 1, which is used with the ICMs. The devices were distributed worldwide, including in the United States and numerous other countries.
The recall was initiated because the devices inappropriately displayed a low battery indicator. This issue was determined to be due to memory corruption. The Confirm Rx ICM is designed to detect arrhythmias and transmit data to the Merlin.net Patient Care Network for patients with unexplained symptoms or a history of atrial fibrillation.
Patients with these specific devices should contact their healthcare provider or St. Jude Medical for further instructions. The recall number is Z-0808-2020.
The recalled product
- Product
- Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. - Product Usage: The Confirm Rx insertable cardiac m
- Category
- Medical Device — Cardiac Monitor
- Affected units
- 2,906
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 (4)
- Merlin PCS Programmer Software
- V24.0.1 rev 1
- UDI 05414734509725. Confirm Rx ICM
- UDI 05415067027320
Distribution
Distributed nationwide across the United States.
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