1. Vaccess CT Power-Injectable Implantable Port with Suture Plugs, Ref: 7496000, UDI:(01)00801741027482 Product Usage: Bard implantable ports are indicated for patient therapies requiring repeated ac...
Reason: Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the correct barb tip for a 9....
Z-1573-2020April 1, 2020Tempe, AZ
Intellijoint Surgical, Inc.
Class IITerminated
Intellijoint Navigation System, Software Application, IJK1 (P/N 000-0547) - Product Usage: The Intellijoint Navigation System is a computer-controlled, optical localizer intended to provide intra-oper...
Reason: During total knee arthroplasty (TKA), the software may incorrectly calculate femur resection depth.
Z-1559-2020April 1, 2020Waterloo, N/A
Bard Peripheral Vascular Inc
Class IITerminated
BardPort M.R.I. Implantable Port with Attachale 9.6 F Open-Ended Single-Lumen Venous Catheter, REF: 0602680, UDI:(01)00801741025679 Product Usage: Bard implantable ports are indicated for patient the...
Reason: Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the correct barb tip for a 9....
Z-1576-2020April 1, 2020Tempe, AZ
Bard Peripheral Vascular Inc
Class IITerminated
1. PowerPort M.R.I. Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter with Suture Plugs, REF: 1809600, UDI: (01)00801741027130 ; 2. PowerPort M.R.I. Implantable Port wit...
Reason: Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the correct barb tip for a 9....
Z-1571-2020April 1, 2020Tempe, AZ
Micro Therapeutics Inc, Dba Ev3 Neurovascular
Class ITerminated
ev3 Pipeline Flex Embolization Device. For neurological endovascular use.
Reason: Embolization device delivery system may fracture at the distal section during device implantation. A weakened bond may result in unintended separation, where the distal portion of ...
Z-1527-2020April 1, 2020Irvine, CA
Micro Therapeutics Inc, Dba Ev3 Neurovascular
Class ITerminated
ev3 Pipeline Flex Embolization Device with Shield Technology. Sold OUS. For neurological endovascular use.
Reason: Embolization device delivery system may fracture at the distal section during device implantation. A weakened bond may result in unintended separation, where the distal portion of ...
Reason: Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging.
Z-1478-2020March 25, 2020Center Valley, PA
Boston Scientific Corporation
Class IITerminated
Boston Scientific, Implantable Cardioverter Defibrillator, DYNAGEN EL ICD DR, Model D152 - Product Usage: Implantable cardioverter defibrillators (ICDs) are intended to provide ventricular anti-tachyc...
Reason: Boston Scientific released a new Software Update Application that was downloaded to four (4) distributed Model 3300 programmers. The Software Update Application then directed these...
Z-1512-2020March 25, 2020Saint Paul, MN
Boston Scientific Corporation
Class IITerminated
Boston Scientific, LATITUDE Programming System, Model 3300 - Product Usage:The Boston Scientific LATITUDE Programming System is intended for use in hospital and clinical environments to communicate wi...
Reason: Boston Scientific released a new Software Update Application that was downloaded to four (4) distributed Model 3300 programmers. The Software Update Application then directed these...
Z-1511-2020March 25, 2020Saint Paul, MN
Aesculap Implant Systems LLC
Class IITerminated
COLUMBUS CR/PS TIB.PLAT.PLASMAPORE, Knee implant components, various sizes, model nos. NN081K NN082K NN083K NN084K NN085K NN086K NN087K NN088K NN089K Product Usage: Tibia-Plateaus are part o...
Reason: Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging.
Z-1479-2020March 25, 2020Center Valley, PA
Aesculap Implant Systems LLC
Class IITerminated
AS COLUMBUS CR/PS TIB.PLAT.CEMENTED,Knee implant components, various sizes, model nos. NN058Z NN070Z NN071Z NN072Z NN073Z NN074Z NN075Z NN076Z NN077Z NN078Z NN079Z NN470Z NN471Z NN472Z ...
Reason: Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging.
Z-1481-2020March 25, 2020Center Valley, PA
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class IIOngoing
Medtronic CareLink Encore 29901 Programmer. Used to interrogate and program Medtronic and Vitatron implantable devices, such as pacemaker/ICD/CRT.
Reason: Medtronic Conexus Telemetry has been determined to contain two primary cyber vulnerabilities: improper access control and the cleartext transmission of sensitive information.
Z-1525-2020March 25, 2020Mounds View, MN
Aesculap Implant Systems LLC
Class IITerminated
COLUMBUS REV F TIBIA OFFSET CEMENTED, Knee implant components, various sizes, model nos. NR068K NR068Z NR070K NR070Z NR071K NR071Z NR072K NR072Z NR073K NR073Z NR074K NR074Z NR075K NR075Z...
Reason: Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging.
Z-1482-2020March 25, 2020Center Valley, PA
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class IIOngoing
Medtronic CareLink 2090 Programmer. Used to interrogate and program Medtronic and Vitatron implantable devices, such as pacemaker/ICD/CRT.
Reason: Medtronic Conexus Telemetry has been determined to contain two primary cyber vulnerabilities: improper access control and the cleartext transmission of sensitive information.
Z-1524-2020March 25, 2020Mounds View, MN
Nextremity Solutions
Class IITerminated
Nextra Hammertoe Correction System-4.5MM Middle, 3.2MM Proximal, SS, Sterile. REF: NX-4532K - Product Usage: The Nextra Hammertoe Correction System is a system of implants and associated instruments ...
Reason: Proximal end of the driver in the affected product may be oversized in varying degrees, potentially making it difficult to connect with and remove from the proximal Nextra implant
Z-1458-2020March 18, 2020Warsaw, IN
Advanced Bionics, LLC
Class IIITerminated
SoundWave Professional Suite Software 3.2, Ref CI-6055-014, SPN 058-023-32085, UDI: (01)07630016853227, Logical SoundWave Professional Suite 3.2, CE 0123 - Product Usage: Soundwave 3.2 is used by heal...
Reason: The manufacturer received complaints that customers were attempting to install the fitting software using the supplied USB drive, an error message was received, and installation fa...