19 results
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55ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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Socrates 38 Aspiration Catheter 127 cm length REF SC038-127-001 The Socrates Aspiration System with a compatible suction pump is intended for use in the revascularization of patients with acute ischemic stroke
FDA Recall
Open, Classified
·Scientia Vascular, Inc.·Product code NRY·January 2, 2025
Plato 17 Microcatheter REF PL17-160-090 To assist in delivery of therapeutic devices and embolization materials and infusion of diagnostic agents to the neuro and peripheral vasculature during interventional or diagnostic procedures.
FDA Recall
Open, Classified
·Scientia Vascular, Inc.·Product code QJP·January 16, 2025
Plato 17 Microcatheter: Straight Tip, PL17-160-000 ; 45 degree Tip, PL17-160-045; 90 degree Tip, PL17-160-090
FDA Recall
Open, Classified
·Scientia Vascular, Inc.·Product code DQY·February 1, 2023
Vaxcel Implantable Vascular Access System - Plastic Standard Port With 9F Polyurethane Catheter, Catalog/REF No. 45-360, UPN/Material No. M001453600, Single Use Only, STERILE, EO, Boston Scientific MEDI-TECH (617) 972-4000/(800) 225--3238, 480 Pleasant Street, Watertown, MA 02472 --- The port is provided as a kit, with various single use, disposable items necessary for achieving vascular access and implanting the port catheter. Each kit is provided in a plastic (PETG) tray with a heat-sealed tyvek lid. This inner tray is then placed in a second outer plastic (PETG) tray, along with the Directions for Use, and also sealed with a tyvek lid which is then labeled. The port kit is placed in a cardboard carton, with additional labels and sealed.
FDA Recall
Terminated
·Boston Scientific Corp·Product code LJT·June 13, 2006
Vaxcel Implantable Vascular Access System -Titanium Standard Port With 9F Polyurethane Catheter, Catalog/REF No. 45-315, UPN/Material No. M001453150, Single Use Only, STERILE, EO. Boston Scientific MEDI-TECH, (617) 972-4000/(800) 225-3238, 480 Pleasant Street, Watertown, MA 02472 --- The port is provided as a kit, with various single use, disposable items necessary for achieving vascular access and implanting the port catheter. Each kit is provided in a plastic (PETG) tray with a heat-sealed tyvek lid. This inner tray is then placed in a second outer plastic (PETG) tray, along with the Directions for Use, and also sealed with a tyvek lid which is then labeled. The port kit is placed in a cardboard carton, with additional labels and sealed.
FDA Recall
Terminated
·Boston Scientific Corp·Product code LJT·June 13, 2006
Navilyst Medical, Inc., Vaxcel(TM) Port with PASV(TM) Titanium Mini-Port with PASV Valve and 8F Silicone Catheter (1.4 mm/2.6 mm), REF Catalog No. 45-220, UPN Product No. M001452200, STERILE, Rx ONLY, For single use only --- Implantable Vascular Access System with PASV(TM) Valve Technology --- (kit contains Huber needle) -- previously distributed by Boston Scientific Corporation.
FDA Recall
Terminated
·Navilyst Medical, Inc·Product code LJT·May 13, 2010
Navilyst Medical, Inc., Vaxcel(TM) Port Titanium Mini-Port with 8F Silicone Catheter (1.5 mm/2.6 mm), REF Catalog No. 45-310, UPN Product No. M001453100, STERILE, Rx ONLY, For single use only --- Implantable Vascular Access System --- (kit contains Huber needle) -- previously distributed by Boston Scientific Corporation.
FDA Recall
Terminated
·Navilyst Medical, Inc·Product code LJT·May 13, 2010
Navilyst Medical, Inc., Vaxcel(TM) Port with PASV(TM) Titanium Standard Port with PASV Valve and 8F Silicone Catheter (1.4 mm/2.6 mm), REF Catalog No. 45-364, UPN Product No. M001453640, STERILE, Rx Only, For single use only --- Common Name: Implantable Vascular Access System with PASV(TM) Valve Technology --- (kit contains Huber needle) -- previously distributed by Boston Scientific Corporation.
FDA Recall
Terminated
·Navilyst Medical, Inc·Product code LJT·May 13, 2010
Navilyst Medical, Inc., Vaxcel(TM) Port with PASV(TM) Titanium Mini-Port with PASV Valve and 6F Polyurethane Catheter (1.1 mm/1.9 mm), REF Catalog No. 45-213, UPN Product No. M001452130, STERILE, Rx ONLY, For Single Use Only --- Implantable Vascular Access System with PASV(TM) Valve Technology - (kit contains Huber needle) -- previously distributed by Boston Scientific Corporation.
FDA Recall
Terminated
·Navilyst Medical, Inc·Product code LJT·May 13, 2010
Navilyst Medical, Inc., Vaxcel(TM) Port with PASV(TM) Titanium Standard Port with PASV Valve and 8F Polyurethane Catheter (1.6 mm/2.6 mm), REF Catalog No. 45-362, UPN Product No. M001453620, STERILE, Rx ONLY, For single use only --- Implantable Vascular Access System with PASV(TM) Valve Technology --- (kit contains Huber needle) -- previously distributed by Boston Scientific Corporation.
FDA Recall
Terminated
·Navilyst Medical, Inc·Product code LJT·May 13, 2010
Navilyst Medical, Inc. Vaxcel(TM) Port Titanium Standard Port with 8F Silicone Catheter (1.5 mm/2.6 mm), REF Catalog No. 45-320, UPN # - M001453200, STERILE, Rx ONLY, For single use only --- Implantable Vascular Access System --- (kit contains Huber needle) -- previously distributed by Boston Scientific Corporation.
FDA Recall
Terminated
·Navilyst Medical, Inc·Product code LJT·May 13, 2010
Navilyst Medical, Inc. Vaxcel(TM) Port titanium Mini-Port with 7F Polyurethane Catheter (1.3 mm/2.2 mm), REF Catalog No. 45-305, UPN Product No. M001453050, STERILE, Rx ONLY, For single use only --- Implantable Vascular Access System --- (kit contains Huber needle) -- previously distributed by Boston Scientific Corporation.
FDA Recall
Terminated
·Navilyst Medical, Inc·Product code LJT·May 13, 2010
Navilyst Medical, Inc., Vaxcel(TM) Port Plastic Standard Port with 9F Polyurethane Catheter (1.8 mm/2.8 mm), REF Catalog No. 45-360, UPN Product No. M001453600, STERILE, Rx ONLY, For single use only --- Implantable Vascular Access System --- (kit contains Huber needle) -- previously distributed by Boston Scientific Corporation.
FDA Recall
Terminated
·Navilyst Medical, Inc·Product code LJT·May 13, 2010
Navilyst Medical, Inc., Vaxcel(TM) Port with PASV(TM) Plastic Standard Port with PASV Valve and 8F Polyurethane Catheter (1.6 mm/2.6 mm), REF Catalog No. 45-366, UPN Product No. M0 01453660, Sterile, Rx ONLY, For single use only --- Implantable Vascular Access System with PASV(TM) Valve Technology --- (kit contains Huber needle) -- previously distributed by Boston Scientific Corporation.
FDA Recall
Terminated
·Navilyst Medical, Inc·Product code LJT·May 13, 2010
Navilyst Medical, Inc. Vaxcel(TM) Port titanium Standard Port with 9F Polyurethane Catheter (1.8 mm/2.8 mm), REF Catalog No. 45-315, UPN Product No. M001453150, STERILE, Rx ONLY, For single use only --- Implantable Vascular Access System --- (kit contains Huber needle) -- previously distributed by Boston Scientific Corporation.
FDA Recall
Terminated
·Navilyst Medical, Inc·Product code LJT·May 13, 2010
Navilyst Medical, Inc., Vaxcel(TM) Port with PASV(TM) Titanium Mini-Port With PASV Valve and 8F Polyurethane Catheter (1.6 mm/2.6 mm), REF Catalog No. 45-215, UPN Product No. M001452150, STERILE, Rx ONLY, For Single Use Only --- Implantable Vascular Access System with PASV(TM) Valve Technology (kit contains Huber needle) -- previously distributed by Boston Scientific Corporation.
FDA Recall
Terminated
·Navilyst Medical, Inc·Product code LJT·May 13, 2010
Navilyst Medical, Inc., Vaxcel(TM) Port with PASV(TM), Plastic Standard Port with PASV Valve and 8F Silicone Catheter (1.4 mm/2.6 mm), REF Catalog No. 45-368, UPN Product No. M001453680, STERILE, Rx ONLY, For Single Use Only --- Implantable Vascular Access System with PASV(TM) Valve Technology --- (kit contains Huber needle) -- previously distributed by Boston Scientific Corporation.
FDA Recall
Terminated
·Navilyst Medical, Inc·Product code LJT·May 13, 2010
Navilyst Medical, Inc. Vaxcel(TM) Port Titanium Mini-Port with 6F Polyurethane Catheter (1.1 mm/1.9 mm), REF Catalog No. 45-303, UPN Product No. M001453030, STERILE, Rx ONLY, For single use only --- Implantable Vascular Access System --- (kit contains Huber needle) -- previously distributed by Boston Scientific Corporation.
FDA Recall
Terminated
·Navilyst Medical, Inc·Product code LJT·May 13, 2010
Navilyst Medical, Inc., Vaxcel(TM) Port Plastic Standard Port with 8F Silicone Catheter (1.5 mm/2.6 mm), REF Catalog No. 45-340, UPN Product No. M001453400, STERILE, Rx ONLY, For single use only --- Implantable Vascular Access System --- (kit contains Huber needle) -- previously distributed by Boston Scientific Corporation.
FDA Recall
Terminated
·Navilyst Medical, Inc·Product code LJT·May 13, 2010