Reason: The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.
Reason: The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.
Z-2369-2024July 24, 2024Plano, TX
Preat Corp
Class IIOngoing
9006767 Astra EV 4.8mm Milled Titanium Abutment Milled abutments are too be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.
Reason: Due to incorrect milled titanium abutment being packaged and labeled.
Reason: Deep brain stimulation system will first turn off after approximately 50 days after the system is activated and subsequently, this same action will recur approximately every 50 day...
Z-2265-2024July 10, 2024Plano, TX
MicroPort Orthopedics Inc.
Class IIOngoing
EVOLUTION¿ MP Femoral CS/CR Non-Porous Non-porous MicroPort total knee replacement implants are for cemented use only.
Reason: One confirmed incident has been received that EFSRN4PR, lot number MP1982170, Size 4 Evolution MP Non-Porous Femoral Right was opened during surgery and contained part number EFSRN...
Reason: Neurostimulation Systems have a manufacturing non-conformance that may reduce the efficiency of the radiofrequency signals between the Implantable Pulse Generator (IPG) and the The...
Z-2257-2024July 10, 2024Carlsbad, CA
Medtronic Inc.
Class IIOngoing
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 ...
Reason: Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Z-2212-2024July 3, 2024Mounds View, MN
Medtronic Inc.
Class IIOngoing
EVERA MRI S DR SureScan, Model Number DDMC3D4, Implantable Cardioverter Defibrillator
Reason: Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Z-2199-2024July 3, 2024Mounds View, MN
Medtronic Inc.
Class IIOngoing
COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, Implantable Cardioverter Defibrillator
Reason: Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Z-2190-2024July 3, 2024Mounds View, MN
Medtronic Inc.
Class IIOngoing
Cobalt XT DR MRI SureScan, Model Number DDPA2D1, Implantable Cardioverter Defibrillator
Reason: Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Z-2209-2024July 3, 2024Mounds View, MN
Medtronic Inc.
Class IIOngoing
CROME HF QUAD CRT-D MRI SureScan, Model Number DTPC2QQ, Implantable Cardioverter Defibrillator
Reason: Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Z-2195-2024July 3, 2024Mounds View, MN
Medtronic Inc.
Class IIOngoing
COBALT XT VR MRI SureScan, Model Number DVPA2D1, Implantable Cardioverter Defibrillator
Reason: Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Z-2210-2024July 3, 2024Mounds View, MN
Medtronic Inc.
Class IIOngoing
CROME VR MRI SureScan, Model Number DVPC3D1, Implantable Cardioverter Defibrillator
Reason: Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Z-2211-2024July 3, 2024Mounds View, MN
Medtronic Inc.
Class IIOngoing
MIRRO MRI DR SureScan, Model Number DDME3D4, Implantable Cardioverter Defibrillator
Reason: Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Z-2202-2024July 3, 2024Mounds View, MN
Medtronic Inc.
Class IIOngoing
EVERA MRI S VR SureScan, Model Number DVMC3D4, Implantable Cardioverter Defibrillator
Reason: Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Z-2197-2024July 3, 2024Mounds View, MN
Inspire Medical Systems Inc.
Class IOngoing
Inspire Model 3028, IV Implantable Pulse Generator
Reason: There is a potential manufacturing defect which can lead to electrical leakage in the sensing circuit which causes a system malfunction and requires a revision surgery to replace t...