Abbott Recalls 32 St. Jude Medical Confirm Rx Insertable Cardiac Monitors
Abbott is recalling 32 St. Jude Medical Confirm Rx Insertable Cardiac Monitors because the devices incorrectly determine that their security certificates have expired, preventing them from pairing with the mobile app.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 defect is a software error preventing app pairing, which is a functional limitation rather than a direct physical hazard like fire or shock. No injuries or illnesses are reported, fitting the criteria for a moderate severity recall involving a significant but non-immediate safety issue.
Plain-English summary
Abbott is recalling 32 units of the St. Jude Medical Confirm Rx Insertable Cardiac Monitor (REF DM3500, Sterile). The recall affects devices with specific serial numbers distributed nationwide in Arizona, California, Colorado, Idaho, Illinois, Louisiana, Massachusetts, Michigan, Missouri, Nebraska, New Hampshire, New Jersey, New York, Tennessee, Texas, and Wisconsin.
The recall was initiated because the devices are unable to pair with the mobile app. This occurs because the devices incorrectly determine that their security certificates have expired. The St. Jude Medical Confirm Rx Insertable Cardiac Monitor is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network. It 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 at risk for cardiac arrhythmias or those with atrial fibrillation.
Patients with these specific devices should contact their healthcare provider or Abbott for instructions on how to proceed. The source text does not report any illnesses or injuries associated with this defect.
The recalled product
- Product
- St. Jude Medical Confirm Rx Insertable Cardiac Monitor, REF DM3500, Sterile. Product Usage: The St. Jude Medical Confirm Rx insertable cardiac monitor (ICM) is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network (PCN). It is…
- Manufacturer
- Abbott
- Category
- Medical Device — Cardiac Monitor
- Affected units
- 32
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 (20)
- Serial numbers 9225191
- 9224501
- 9225179
- 9225193
- 9225207
- 9242209
- 9257638
- 9257646
- 9257656
- 9257659
- 9224508
- 9224490
- 9224503
- 9224525
- 9224529
- 9225190
- 9225203
- 9225205
- 9225208
- 9225211
Distribution
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