FDADecember 19, 2017device
Implantable Cardioverter Defibrillators (ICDs), Evera MRI. Labeled as the following: a. Evera MRI XT DR ICD DF1 (Product No. DDMB1D1); b. Evera MRI XT DR ICD DF4 (Product No. DDMB1D4); c. Evera MRI XT VR ICD DF4 (Product No. DVMB1D4); d. Evera MRI S DR ICD DF1 (Product No. DDMC3D1); EXPANSION: e....
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D).
What to do
FDA enforcement status: Terminated
Brands named
medtronic inc cardiac rhythm and heart failure crhfmedtronicmedtronic inc
UPCs
00643169929197006431697172820064316992920300643169314092006431693141530064316971724400643169314139
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- CPSCMissry Associates Recalls Misco Sports Light-Up Racket Sets Due to Risk of Serious Injury or Death from Battery Ingestion; Violate Mandatory Standard for Toys2026-05-28
- CPSCMiniWarGaming and Primal Horizon Disc Magnets Recalled Due to Risk of Serious Injury or Death from Ingestion; Violate Mandatory Standard for Magnets; Imported by MiniWarGaming2026-05-28
- FDAMedtronic O-arm O2 Imaging System. Model Number: BI70002000.2026-05-19
- FDADRAGONFLY Thai Ginger Powder Net Weight: 4.37 oz (125 g) PRODUCT OF THAILAND Packed for: U.S. Trading Company Hayward, CA 94545-1130 UPC: 7215575335672026-05-15
- CPSCPetzl America Recalls SIMBA and SWAN EASYFIT Harnesses Due to Risk of Serious Injury or Death from Fall Hazard2026-05-14
- CPSCMissry Associates Recalls Misco Sports Badminton Toy Sets Due to Risk of Serious Injury or Death from Battery Ingestion; Violates Mandatory Standard for Toys2026-05-14
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