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Sources: EU EUDAMED, US FDA
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EkoSonic Endovascular System, Catalog Number 500-56112. It consists of three main components, a single use EkoSonic Endovascular Device which is comprised of an Intelligent Drug Delivery Catheter (IDDC) and removable MicroSonic Device (MSD), and a reusable EKOS EkoSonic Control System. During use, fluids are delivered through the side-holes of the IDDC. The MSD is placed through the central lumen of the IDDC to deliver ultrasound energy along the length of fluid delivery, dispersing the fluid into the intravascular treatment site. The reusable EKOS EkoSonic Control Unit provides power to the system and the user interface for operator control. A reusable, non-sterile Connector Interface Cable connects the EKOS EkoSonic Control Unit to the EkoSonic Endovascular Device.
FDA Enforcement
Class II
·Terminated·EKOS Corporation·March 2, 2016
EkoSonic Endovascular System, Catalog Number 500-56112. It consists of three main components, a single use EkoSonic Endovascular Device which is comprised of an Intelligent Drug Delivery Catheter (IDDC) and removable MicroSonic Device (MSD), and a reusable EKOS EkoSonic Control System. During use, fluids are delivered through the side-holes of the IDDC. The MSD is placed through the central lumen of the IDDC to deliver ultrasound energy along the length of fluid delivery, dispersing the fluid into the intravascular treatment site. The reusable EKOS EkoSonic Control Unit provides power to the system and the user interface for operator control. A reusable, non-sterile Connector Interface Cable connects the EKOS EkoSonic Control Unit to the EkoSonic Endovascular Device.
FDA Recall
Terminated
·EKOS Corporation·Product code KRA·January 21, 2016
MaxTorque Cannulated Screw Model # MSD-010-55-060S
FDA Recall
Terminated
·Orthohelix Surgical Designs Inc·Product code HWC·April 7, 2009
EkoSonic MACH4 Endovascular Device (Catalog #500-55106, 500-55112; 500-55118; 500-55124; 500-55130; 500-55140; 500-55150; 500-54106; 500-56130; 500-56140; 500-56150) is a catheter, continuous infusion. it consists of the Intelligent Drug Delivery Catheter (IDDC) and the MicroSonic Device (MSD). It is intended for the controlled and selective infusion of physician-specific fluids, including thrombolytics, into the peripheral vasculature. All therapeutic agents utilized with the EkoSonic Endovascular System should be fully prepared and used according to the instruction for use of the specific therapeutic agent. The Kit MACH4 is labeled in parts: "***EkoSonic MACH4 Endovascular Device***MicroSonic Device and Intelligent Drug Delivery Catheter***". The Pouch MSD is labeled in parts: "***EKOS***MicroSonic Device***Sterile***". EkoSonic Endovascular System is a catheter, continuous infusion. It is intended for the controlled and selective infusion of physician-specific fluids, including thrombolytics, into the peripheral vasculature. The system is also intended for the infusion of solutions into pulmonary arteries.
FDA Recall
Terminated
·EKOS Corporation·Product code KRA·May 24, 2012
The EKOS EkoSonic Control Unit is intended exclusively for use with the EkoSonic Endovascular Device and the EkoSonic MACH4 Endovascular Device. The EkoSonic Endovascular System consists of three main components: -a single use EkoSonic Endovascular Device which is comprised of an Intelligent Drug Delivery Catheter (IDDC) and -removable MicroSonic Device (MSD), and -a reusable EKOS EkoSonic Control System. During use, fluids are delivered through the side-holes of the IDDC. The MSD is placed through the central lumen of the IDDC to deliver ultrasound energy along the length of fluid delivery, dispersing the fluid into the intravascular treatment site. The reusable EKOS EkoSonic Control Unit provides power to the system and the user interface for operator control. A reusable, nonsterile Connector Interface Cable connects the EKOS EkoSonic Control Unit to the EkoSonic Endovascular Device.
FDA Enforcement
Class II
·Terminated·EKOS Corporation·July 29, 2015
Medstream 81" (206 cm) 20 Drop Standard bore Universal Administration Set with Y-Site, Sterile Manufactured for MSD (Medical Specialties Distributors LLC, Stoughton, MA. Product of China Product Number: MS721 Disposable Infusion set
FDA Enforcement
Class II
·Terminated·Medical Specialties Distributors, Inc.·August 15, 2012
Ingenuity TF PET/CT, Model No. 882442 Product Usage: The device is an integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) system suitable for a wide range of diagnostic applications. The device utilizes the CT technology to obtain anatomic images of the human body and PET technology to obtain functional images of the human body. The clinical value of both technologies increases with the capability to fuse the CT and PET images using Philips fusion viewer Image Fusion software to create a composite image for diagnostic study and therapeutic planning. The system also provides tools for the quantification of results of the CT and PET images and provides the means for a simplified review of the CT, PET, and fused images. The integration of the anatomical data from CT with the metabolic data from PET gives clinicians the visual information necessary to define the severity, as well as the extent, of the disease.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code KPS·February 15, 2018
The EKOS EkoSonic Control Unit is intended exclusively for use with the EkoSonic Endovascular Device and the EkoSonic MACH4 Endovascular Device. The EkoSonic Endovascular System consists of three main components: -a single use EkoSonic Endovascular Device which is comprised of an Intelligent Drug Delivery Catheter (IDDC) and -removable MicroSonic Device (MSD), and -a reusable EKOS EkoSonic Control System. During use, fluids are delivered through the side-holes of the IDDC. The MSD is placed through the central lumen of the IDDC to deliver ultrasound energy along the length of fluid delivery, dispersing the fluid into the intravascular treatment site. The reusable EKOS EkoSonic Control Unit provides power to the system and the user interface for operator control. A reusable, nonsterile Connector Interface Cable connects the EKOS EkoSonic Control Unit to the EkoSonic Endovascular Device.
FDA Recall
Terminated
·EKOS Corporation·Product code KRA·June 24, 2015
Medstream 81" (206 cm) 20 Drop Standard bore Universal Administration Set with Y-Site, Sterile Manufactured for MSD (Medical Specialties Distributors LLC, Stoughton, MA. Product of China Product Number: MS721 Disposable Infusion set
FDA Recall
Terminated
·Medical Specialties Distributors, Inc.·Product code FPA·August 3, 2012
EkoSonic MACH4 Endovascular Device (Catalog #500-55106, 500-55112; 500-55118; 500-55124; 500-55130; 500-55140; 500-55150; 500-54106; 500-56130; 500-56140; 500-56150) is a catheter, continuous infusion. it consists of the Intelligent Drug Delivery Catheter (IDDC) and the MicroSonic Device (MSD). It is intended for the controlled and selective infusion of physician-specific fluids, including thrombolytics, into the peripheral vasculature. All therapeutic agents utilized with the EkoSonic Endovascular System should be fully prepared and used according to the instruction for use of the specific therapeutic agent. The Kit MACH4 is labeled in parts: "***EkoSonic MACH4 Endovascular Device***MicroSonic Device and Intelligent Drug Delivery Catheter***". The Pouch MSD is labeled in parts: "***EKOS***MicroSonic Device***Sterile***". EkoSonic Endovascular System is a catheter, continuous infusion. It is intended for the controlled and selective infusion of physician-specific fluids, including thrombolytics, into the peripheral vasculature. The system is also intended for the infusion of solutions into pulmonary arteries.
FDA Enforcement
Class II
·Terminated·EKOS Corporation·July 25, 2012
28CM ALTA EXCHANGE KIT Model: AL23SH28 XP ALTA EXCHANGE KIT 15.5 Fr polyurethane twin lumen fixed tip hemodialysis catheter, cuff and side holes for chronic hemodialysis and apheresis. Latex free.
FDA Recall
Terminated
·Spire Biomedical, Inc. One Patriots Park·Product code MSD·October 23, 2009
40CM DECATHLON GOLD STD KIT Models: DEC35SH40 and DEC35SH40-K DECATHLON GOLD 15.5 Fr polyurethane twin lumen Heparin coated hemodialysis catheter with separated tips, cuff and side holes for chronic hemodialysis and apheresis. Kit contains catheter, 18 gauge introducer needle, 12cc syringe, J/straight 0.038 inch guidewire, 12Fr dilator, 14Fr dilator, 16Fr peel-away sheath/dilator, #11 scalpel, tunneling stylet, (4) gauze sponges, wound dressing, (2) injection sealing caps, and warning label. Latex free.
FDA Recall
Terminated
·Spire Biomedical, Inc. One Patriots Park·Product code MSD·October 23, 2009
55CM DECATHLON STD KIT Models: DE50SH55 and DE50SH55-K 15.5 Fr Polyurethane twin lumen hemodialysis catheter with separated tips, cuff and side holes for chronic hemodialysis and apheresis.
FDA Recall
Terminated
·Spire Biomedical, Inc. One Patriots Park·Product code MSD·October 23, 2009
24CM ALTA LR GOLD STD KIT Model: ALC19SH24 ALTA GOLD 15.5 Fr polyurethane twin lumen fixed tip heparin coated hemodialysis catheter, cuff and side holes for chronic hemodialysis and apheresis. Kit contains catheter, 18 gauge introducer needle, 12cc syringe, J/straight 0.038 inch x 100 cm marked guidewire, 12Fr dilator, 14Fr dilator, 16Fr valved peel-away sheath/dilator, #11 scalpel, tunneling stylet, (4) gauze sponges, wound dressing, (2) injection sealing caps, and warning label. Latex free.
FDA Recall
Terminated
·Spire Biomedical, Inc. One Patriots Park·Product code MSD·October 23, 2009
36CM DECATHLON FUNNEL TIP STD KIT Model: DF31SH36 DECATHLON FUNNEL TIP 15.5 Fr polyurethane twin lumen hemodialysis catheter with separated funnel tips, cuff and side holes for chronic hemodialysis and apheresis. Kit contains catheter with stylet, 18 gauge introducer needle, 12cc syringe, J/straight 0.038 inch guidewire, 12Fr dilator, 14Fr dilator, 16Fr peel-away sheath/dilator, #11 scalpel, tunneling stylet, (4) gauze sponges, wound dressing, (2) injection sealing caps, and warning label. Latex free
FDA Recall
Terminated
·Spire Biomedical, Inc. One Patriots Park·Product code MSD·October 23, 2009
ARROW Edge Hemodialysis Catherization Set with Arrow Simplicity", Long-Term Access, Cuff to Tip: 19cm, CS-15242-IM, Intended for single use only, Sterile, Rx only, Arrow International, Inc., 2400 Bernville Road, Reading, PA 19605, USA The product is used for long term hemodialysis vascular access.
FDA Recall
Terminated
·Arrow International Inc·Product code MSD·June 10, 2008
Cannon Catheter" II, Long-Term Access. Catheter Length, Cuff to Tip: 31cm, CSD-15362, Intended for single use only, Sterile, Rx only, Arrow International, Inc., 2400 Bernville Road, Reading, PA 19605, USA The product is used for long term hemodialysis vascular access.
FDA Recall
Terminated
·Arrow International Inc·Product code MSD·June 10, 2008
Cannon" II Plus, Long-Term Access. Catheter Length, Cuff to Tip: 23cm, CS-15282-SP, Intended for single use only, Sterile, Rx only, Arrow International, Inc., 2400 Bernville Road, Reading, PA 19605, USA The product is used for long term hemodialysis vascular access.
FDA Recall
Terminated
·Arrow International Inc·Product code MSD·June 10, 2008
DURAMAX (TM) Hemodialysis Catheters, Stack Tip 28 cm Pre-Curve Basic Kit, Catalog Number/REF 10302813, 510 (k) 080400, Sterile --- Manufactured in USA by AngioDynamics, Inc. 603 Queensbury Avenue, Queensbury, NY 12804
FDA Recall
Terminated
·Angiodynamics, Inc.·Product code MSD·January 8, 2010
DURAMAX (TM) Hemodialysis Catheters, Stacked Tip 28 cm Straight Basic Kit, Catalog Number/REF 10302804, 510 (k) 080400, Sterile --- Manufactured in USA by AngioDynamics, Inc. 603 Queensbury Avenue, Queensbury, NY 12804
FDA Recall
Terminated
·Angiodynamics, Inc.·Product code MSD·January 8, 2010