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Assert-IQ™
ST. JUDE MEDICAL, INC. · Model DM5500 · UDI-DI 05415067047809
MXC
Prescription
1
510(k) clearances
11,316
Adverse events (19 deaths)
5
Recalls
6
Facilities
Description
EL+ Insertable Cardiac Monitor
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-11-19 | Abbott | The device is unable to pair with the mobile app due to the device incorrectly determining the certificate has expired. |
| 2018-04-16 | St Jude Medical Inc. | 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 |
| 2018-04-16 | St Jude Medical Inc. | 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 |
| 2018-04-13 | St Jude Medical, Cardiac Rhythm Management Division | Devices inappropriately displayed a low battery indicator determined to be due to memory corruption. |
| 2011-03-31 | St Jude Medical CRMD | The recall was initiated because St. Jude Medical made new software available for the SJM Confirm DM2100 implantable cardiac monitor (ICM) that incorporates enhancements to the dev |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.