FDAFDA · Food and drugs·Recall number Z-2192-2024
Cobalt XT HF CDT-D MRI SureScan, Model Number: DTPA2D4, Implantable Cardioverter Defibrillator
Published July 3, 2024 · Recall initiated: April 16, 2024
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
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Medtronic Inc.
- Distributor
- Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, Croatia, Czech Republic, France, Georgia, Germany, Greece, Guadeloupe, Iceland, Ireland, Italy, Jordan, Kosovo, Latvia, Moldova, Republic Of, Netherlands, Northern Ireland, Norway, Oman, Panama, Poland, Portugal, Qatar, Reunion, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.
- Lot
- GTIN: 00763000178130, Serial Numbers: RTG612496S, RTG612497S, RTG612498S, RTG612499S, RTG612502S, RTG612503S, RTG612504S, RTG612505S, RTG612509S, RTG612512S, RTG612513S, RTG612549S, RTG612553S, RTG612556S.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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