COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, Implantable Cardioverter Defibrillator
Reported: July 3, 2024 Initiated: April 16, 2024 #Z-2190-2024
Product Description
COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, Implantable Cardioverter Defibrillator
Reason for Recall
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Details
- Recalling Firm
- Medtronic Inc.
- Units Affected
- 14
- Distribution
- 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.
- Location
- Mounds View, MN
Frequently Asked Questions
What product was recalled? ▼
COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, Implantable Cardioverter Defibrillator. Recalled by Medtronic Inc.. Units affected: 14.
Why was this product recalled? ▼
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 3, 2024. Severity: Moderate. Recall number: Z-2190-2024.
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