Recall Z-2193-2024— Medtronic Inc.
Class II · Ongoing
Class II FDA medical device recall by Medtronic Inc., initiated 2024-04-16. FDA's recall record names no specific 510(k) clearance for this event. Product: COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2Q1, Implantable Cardioverter Defibrillator. Reason: Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing..
- Recalling firm
- Medtronic Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-04-16
- Firm location
- Mounds View, MN, United States
Product description
COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2Q1, Implantable Cardioverter Defibrillator
Reason for recall
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Data sourced from openFDA. This site is unofficial and independent of the FDA.