Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,105 results found for implant Page 28 of 125
Medtronic Neuromodulation
Class II Ongoing
Vanta Clinician Programmer Application, Model A71200. For programming of the Medtronic Model 977006 Vanta implantable neurostimulators for pain therapy.
Reason: Potential communication issue in which the Vanta Clinician Programmer Application (CP App) A71200 v2.0.2455 may be unable to connect with a Vanta Implantable Neurostimulator (INS)...
Z-1574-2022 August 31, 2022 Minneapolis, MN
Aesculap Implant Systems LLC
Class II Terminated
Aeos¿ Robotic Digital Microscope with software versions 2.7 or earlier Article Number: PV010
Reason: Application error problems: Rebalance scope message: 1.Rebalancing process 2.Usage of Robot Recovery: 3. Autofocus not available:
Z-1516-2022 August 17, 2022 Center Valley, PA
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class I Ongoing
Crome Implantable Cardioverter Defibrillators: a. Crome VR ICD, Model Numbers: DVPC3D1, DVPC3D4; b. Crome DR ICD, Model Numbers: DDPC3D1, DDPC3D4
Reason: There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter defibrillators (ICDs) and...
Z-1489-2022 August 17, 2022 Mounds View, MN
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class I Ongoing
Cobalt Implantable Cardioverter Defibrillators: a. Cobalt XT VR ICD, Model Numbers: DVPA2D1, DVPA2D4; b. Cobalt XT DR ICD, Model Numbers: DDPA2D1, DDPA2D4
Reason: There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter defibrillators (ICDs) and...
Z-1485-2022 August 17, 2022 Mounds View, MN
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class I Ongoing
Cobalt Implantable Cardioverter Defibrillators: a. Cobalt VR ICD, Model Numbers: DVPB3D1, DVPB3D4; b. Cobalt DR ICD, Model Numbers: DDPB3D1, DDPB3D4
Reason: There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter defibrillators (ICDs) and...
Z-1487-2022 August 17, 2022 Mounds View, MN
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class I Ongoing
Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Cobalt XT HF CRT-D, Model Numbers: DTPA2D4, DTPA2D1; b. Cobalt XT HF Quad CRT-D, Model Numbers: DTPA...
Reason: There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter defibrillators (ICDs) and...
Z-1486-2022 August 17, 2022 Mounds View, MN
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class I Ongoing
Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Cobalt HF CRT-D, Model Numbers: DTPB2D4, DTPB2D1; b. Cobalt HF Quad CRT-D, Model Numbers: DTPB2QQ, D...
Reason: There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter defibrillators (ICDs) and...
Z-1488-2022 August 17, 2022 Mounds View, MN
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class I Ongoing
Crome Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Crome HF CRT-D, Model Numbers: DTPC2D4, DTPC2D1; b. Crome HF Quad CRT-D, Model Numbers: DTPC2QQ, DTPC...
Reason: There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter defibrillators (ICDs) and...
Z-1490-2022 August 17, 2022 Mounds View, MN
St. Jude Medical, Cardiac Rhythm Management Division
Class II Ongoing
Merlin.net model MN5000 Software
Reason: The Merlin" 2 PCS model MER3700 is a portable, dedicated programming system designed to interrogate, program, display data from, and test Abbott Medical implantable medical devic...
Z-1497-2022 August 10, 2022 Sylmar, CA
Aesculap Implant Systems LLC
Class II Completed
PRESTIGE RETRACTION GRASPER, W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8361-10
Reason: Endoscopic graspers may become separated at the weld from handle to the shaft of the device.
Z-1482-2022 August 10, 2022 Center Valley, PA
Neotract Inc
Class II Ongoing
UroLift System REF UL400-4, QTY 4 Urolfit System with Handle Release Tool
Reason: There is the potential that during implant deployment, the device may not properly deliver a implant.
Z-1502-2022 August 10, 2022 Pleasanton, CA
Aesculap Implant Systems LLC
Class II Completed
PRESTIGE ATRAUMATIC GRASPER W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8360-10
Reason: Endoscopic graspers may become separated at the weld from handle to the shaft of the device.
Z-1481-2022 August 10, 2022 Center Valley, PA
St. Jude Medical, Cardiac Rhythm Management Division
Class II Ongoing
Merlin 2 PCS MER37000 programmer Model MER3400 software
Reason: The Merlin" 2 PCS model MER3700 is a portable, dedicated programming system designed to interrogate, program, display data from, and test Abbott Medical implantable medical devic...
Z-1496-2022 August 10, 2022 Sylmar, CA
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class II Ongoing
Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D)
Reason: Manufacturing error that may have resulted in a cathode component being out of specification. All devices met final functional testing requirements.
Z-1480-2022 August 3, 2022 Mounds View, MN
Paragon 28, Inc.
Class II Ongoing
HammerTube Implant, 2.75mm, 10¿ Cannulated (Sterile)
Reason: Due to Titanium plasma coating not present implant.
Z-1468-2022 August 3, 2022 Englewood, CO
Aesculap Implant Systems LLC
Class II Terminated
Aesculap Sterile disposable fleece drape, Product code: GA414, individually packaged, 50 pieces per shipping unit, product code SZ380R.
Reason: Packaging seal integrity not validated resulting in a lack of sterility assurance.
Z-1449-2022 July 27, 2022 Center Valley, PA
Aesculap Implant Systems LLC
Class II Completed
ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument used during orthopedic implant surgery.
Reason: Nonfunctional key due to the potential for damage to the key pins cause by force of use during assembly of the tibia locking ring.
Z-1391-2022 July 27, 2022 Center Valley, PA
Aesculap Implant Systems LLC
Class II Terminated
MODULIFT VBR SZ.M 4MM SET SCREW DRIVER, MF790R, part of Modulift VBR Medium Instrument Set, ST-0441
Reason: Set screwdriver fails during surgery by deforming at the tip during engagement and manipulation of the implant.
Z-1410-2022 July 27, 2022 Center Valley, PA
Aesculap Implant Systems LLC
Class II Terminated
AESCULAP S4 Cervical Cross Connector L 28-33mm, S4C CROSS CONNECTOR VARIABLE 28-33MM, SW115T. Used in spinal fusion surgery.
Reason: Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement of the connectors on the rods and/or microparticle abrasion.
Z-1446-2022 July 27, 2022 Center Valley, PA
Aesculap Implant Systems LLC
Class II Terminated
ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R
Reason: Fracture or breakage of the spinal fixation arm at the downtube instrument if the 90 degree angle is not met when using the removal key with the spinal fixation system. Redesign of...
Z-1429-2022 July 27, 2022 Center Valley, PA
Aesculap Implant Systems LLC
Class II Terminated
RIGHT CORONAL BENDER, TEK1940. Instrument used during spinal surgery.
Reason: Customized coronal rod benders may deform the implant when used with the spinal system devices.
Z-1405-2022 July 27, 2022 Center Valley, PA
Aesculap Implant Systems LLC
Class II Terminated
AESCULAP S4 Cervical Cross Connector L 42-58mm, S4C CROSS CONNECTOR VARIABLE 42-58MM, product code SW117T. Used in spinal fusion surgery.
Reason: Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement of the connectors on the rods and/or microparticle abrasion.
Z-1448-2022 July 27, 2022 Center Valley, PA
Aesculap Implant Systems LLC
Class II Terminated
AESCULAP S4 Cervical Cross Connector L22mm, S4C CROSS CONNECTOR FIXED 22MM, product code SW112T. Used in spinal fusion surgery.
Reason: Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement of the connectors on the rods and/or microparticle abrasion.
Z-1443-2022 July 27, 2022 Center Valley, PA
Aesculap Implant Systems LLC
Class II Terminated
AESCULAP S4 Cervical Cross Connector, L26mm, S4C CROSS CONNECTOR FIXED 26MM, product code SW114T. Used in spinal fusion surgery.
Reason: Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement of the connectors on the rods and/or microparticle abrasion.
Z-1445-2022 July 27, 2022 Center Valley, PA
Aesculap Implant Systems LLC
Class II Terminated
AESCULAP S4 Cervical Cross Connector L24mm, S4C CROSS CONNECTOR FIXED 24MM, product code SWT113T. Used in spinal fusion surgery.
Reason: Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement of the connectors on the rods and/or microparticle abrasion.
Z-1444-2022 July 27, 2022 Center Valley, PA