FDA-Device2024-07-03Class II
CROME HF QUAD CRT-D MRI SureScan, Model Number DTPC2QQ, Implantable Cardioverter Defibrillator
Medtronic Inc.
Hazard
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Sold states
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.
Affected count
26 units
Manufactured in
8200 Coral Sea St Ne, Mounds View, MN, United States
Products
CROME HF QUAD CRT-D MRI SureScan, Model Number DTPC2QQ, Implantable Cardioverter Defibrillator
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2195-2024Don't want to check this manually?
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