Recall Z-2212-2024— Medtronic Inc.

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: Product not distributed in the US. Implantable Cardioverter Defibrillators: a. VIVA QUAD XT CRT-D, Model Number DTBA2QQ. b. CLARIA MRI CRT-D SureScan, Model Number DTMA2D1. c. CLARIA MRI QUAD CRT-D SureScan, Model Number DTMA2QQ. d. AMPLIA MRI CRT-D SureScan, Model Number DTMB2D1. e. AMPLIA MRI CRT-D SureScan, Model Number DTMB2D4. f. AMPLIA MRI QUAD CRT-D SureScan, Model Number DTMB2Q1. g. AMPLIA MRI QUAD CRT-D SureScan, Model Number DTMB2QQ. h. COMPIA MRI QUAD CRT-D SureScan, Model Number DTMC2QQ. i. EVERA MRI XT DR SureScan, Model Number DDMB2D4. j. VISIA AF MRI XT VR SureScan, Model Number DVFB2D1. k. VISIA AF MRI S VR SureScan, Model Number DVFC3D4. l. VISIA AF MRI XT VR SureScan, Model Number DVFB2D4.. 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

Data sourced from openFDA. This site is unofficial and independent of the FDA.