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Fortify Assura™
ST. JUDE MEDICAL, INC. · Model CD1257-40 · UDI-DI 05414734505468
NVZ
Prescription
0
510(k) clearances
96,105
Adverse events (3,922 deaths)
43
Recalls
35
Facilities
Description
Tiered-therapy cardioverter/defibrillator VVEV VVIR
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-09-24 | Medtronic, Inc. | Software problem has the potential for an inaccurate displayed longevity estimate. |
| 2026-09-24 | Medtronic, Inc. | Software problem has the potential for an inaccurate displayed longevity estimate. |
| 2026-09-24 | Medtronic, Inc. | Software problem has the potential for an inaccurate displayed longevity estimate. |
| 2025-06-18 | Medtronic, Inc. | In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, there was a limited window of time for the user to abort a t |
| 2025-06-18 | Medtronic, Inc. | In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, there was a limited window of time for the user to abort a t |
| 2025-04-29 | Medtronic, Inc. | Identified devices may experience sudden battery power failure without alarm, power supply power-on-resets, and interruption of therapy. Potential patient harms include insufficien |
| 2024-10-01 | Abbott Medical | Due to heart transmitter not being able to upgrade to the current software version in the field after experiencing a power interruption during a prior over-the-wire software downlo |
| 2024-10-01 | Abbott Medical | Due to heart transmitter not being able to upgrade to the current software version in the field after experiencing a power interruption during a prior over-the-wire software downlo |
| 2024-07-11 | Medtronic Inc. | Medtronic CareLink 2090 programmers with serial number prefixes PKK0 and PKK1 have the potential for autonomous cursor motion when Finger Touchscreen capability is enabled by softw |
| 2021-11-08 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) | The back of some Medical Device Identification Cards provided to patients were printed with an erroneous statement stating the following: "This patient has a complete MR condition |
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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.