Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class IOngoing
ICD-VR VISIA AF XT OUS DF4, Model Number DDVAB2D4; Implantable Cardioverter Defibrillators
Reason: There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchr...
Z-1792-2023June 28, 2023Mounds View, MN
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class IOngoing
ICD-DR DDBC3D1 EVERA S IS1/DF1 GLOB, Model Number DDBC3D1; Implantable Cardioverter Defibrillators
Reason: There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchr...
Z-1709-2023June 28, 2023Mounds View, MN
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class IOngoing
ICD DDPA2D4G COBALT XT DR MRI DF4 GOLD, Model Number DDPA2D4G; Implantable Cardioverter Defibrillators
Reason: There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchr...
Z-1724-2023June 28, 2023Mounds View, MN
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class IOngoing
ICD-DR DDMD3D1 PRIMO MRI, Model Number DDMD3D1; Implantable Cardioverter Defibrillators
Reason: There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchr...
Z-1717-2023June 28, 2023Mounds View, MN
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class IOngoing
CRTD DTMA2Q1 CLARIA MRI QUAD OUS DF1, Model Number DTMA2Q1; Implantable Cardioverter Defibrillators
Reason: There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchr...
Z-1759-2023June 28, 2023Mounds View, MN
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class IOngoing
CRT-D DTBB2Q1 VIVA QUAD S IS4/DF1 INTL, Model Number DTBB2Q1; Implantable Cardioverter Defibrillators
Reason: There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchr...
Z-1747-2023June 28, 2023Mounds View, MN
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class IOngoing
ICD COBALT DR MRI IS1 DF4, Model Number DDPB3D4; Implantable Cardioverter Defibrillators
Reason: There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchr...
Z-1726-2023June 28, 2023Mounds View, MN
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class IOngoing
ICD-VR VISIA AF S US/OUS IS1/DF1, Model Number DVAC3D1; Implantable Cardioverter Defibrillators
Reason: There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchr...
Z-1793-2023June 28, 2023Mounds View, MN
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class IOngoing
CRTD DTMA1Q1 CLARIA MRI QUAD US DF1, Model Number DTMA1Q1; Implantable Cardioverter Defibrillators
Reason: There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchr...
Z-1755-2023June 28, 2023Mounds View, MN
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class IOngoing
ICD-DR DDBB2D4 EVERA XT IS1/DF4 INTL, Model Number DDBB2D4; Implantable Cardioverter Defibrillators
Reason: There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchr...
Z-1708-2023June 28, 2023Mounds View, MN
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class IOngoing
CRTD CROME HF QUAD MRI IS4 DF1, Model Number DTPC2Q1; Implantable Cardioverter Defibrillators
Reason: There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchr...
Z-1787-2023June 28, 2023Mounds View, MN
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class IOngoing
CRTD DTMC2D1 COMPIA MRI OUS DF1, Model Number DTMC2D1; Implantable Cardioverter Defibrillators
Reason: There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchr...
Z-1771-2023June 28, 2023Mounds View, MN
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class IOngoing
CRTD CROME HF MRI IS1 DF4, Model Number DTPC2D4; Implantable Cardioverter Defibrillators
Reason: There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchr...
Z-1786-2023June 28, 2023Mounds View, MN
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class IOngoing
ICD-VR DVFB2D1 VISIA AF MRI XT OUS DF1, Model Number DVFB2D1; Implantable Cardioverter Defibrillators
Reason: There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchr...
Z-1805-2023June 28, 2023Mounds View, MN
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class IOngoing
CRT-D DTBA1D1G DF1 VIVA XT US GOLD CTD, Model Number DTBA1D1G; Implantable Cardioverter Defibrillators
Reason: There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchr...
Z-1730-2023June 28, 2023Mounds View, MN
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class IOngoing
CRT-D DTBA2Q1 VIVA QUAD XT IS4/DF1 INTL, Model Number DTBA2Q1; Implantable Cardioverter Defibrillators
Reason: There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchr...
Z-1738-2023June 28, 2023Mounds View, MN
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class IOngoing
ICD-VR DVBB2D4 EVERA XT DF4 INTL, Model Number DVBB2D4; Implantable Cardioverter Defibrillators
Reason: There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchr...
Z-1798-2023June 28, 2023Mounds View, MN
Boston Scientific Neuromodulation Corporation
Class IIOngoing
Driver Instrument, part of the Superion Indirect Decompression System, REF: 102-9800, used with the Superion Indirect Decompression System IFU, Superion IDS Kit IFU, Surgical Technique Manual
Reason: Pending update to indirect decompression system instructions for use informing users that excessive force during the implant procedure may cause driver instrument tip breaks, which...
Z-1972-2023June 21, 2023Valencia, CA
Bolton Medical Inc.
Class IIOngoing
The TREO ABDOMINAL STENT-GRAFT SYSTEM (TREO) consists of four types of implants, specifically a Main Bifurcated Stent-Graft, a Leg Extension Stent-Graft, a Proximal Cuff Stent-Graft and a Straight Ili...
Reason: Potential for the incorrect size stent-graft than the printed carton label.
Z-1689-2023June 14, 2023Sunrise, FL
Linkbio Corp.
Class IIOngoing
LINK SymphoKnee System L-Shaped Femoral Augment, Medial-Right/Lateral-Left, Sz 5-6 Tilastan, cemented. Intended for primary and revision total knee replacement. Item Number: 880-325/13
Reason: Contains the incorrect implant in the packaging. The packaging incorrectly contains the opposite side of the implant (Lateral-Right/Medial-Left instead of Medial-Right/Lateral-Left...
Z-1674-2023June 7, 2023Rockaway, NJ
Hiossen Inc.
Class IIOngoing
ET III Nano-HA fixture System ET NH Dental Implant Model # ET3R5010B -Intended for Dental Implant Catalog #: AET3R5010B
Reason: Mis-labeled length of the dental implant on the Recall Implant's package. Dental implant size D5.0 x L8.5mm, labeled as D5.0 x L10mm
Z-1604-2023May 24, 2023Fairless Hills, PA
Aesculap Implant Systems LLC
Class IIOngoing
Aesculap Caiman Articulating D5/360MM - An electrosurgical cutting and coagulation device for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery, and may in...
Reason: Potential for the spring to become loose and fall out of the device, if the spring falls out during a surgical procedure, it may enter the patient's body.
Z-1569-2023May 17, 2023Center Valley, PA
Linkbio Corp.
Class IIOngoing
LINK SLED Knee System: ENDO SLED KNEE FEM COMP, MEDIUM Item Number: 15-2020/52
Reason: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wea...
Z-1509-2023May 10, 2023Rockaway, NJ
Linkbio Corp.
Class IIOngoing
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 45 MM Item Number: 15-2230/04
Reason: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wea...
Z-1545-2023May 10, 2023Rockaway, NJ
Linkbio Corp.
Class IIOngoing
LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 8 MM X 55 MM Item Number: 15-2030/15
Reason: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wea...