FDAFDA · Food and drugs·Recall number Z-1480-2022
Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D)
Published August 3, 2022 · Recall initiated: November 5, 2020
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Manufacturing error that may have resulted in a cathode component being out of specification. All devices met final functional testing requirements.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Distributor
- US Nationwide distribution in the states of Indiana and CA.
- Lot
- GTIN 00763000178178, Serial Numbers: RTK601865S, RTK601825S, RTK601828S
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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