Medical Devices Recalls
Defective surgical instruments, diagnostic equipment, and health device recalls.
eTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-152
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
MiniMed 770G Insulin Pump (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT...
All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
MiniMed 720G Insulin Pump (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867)
All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
THORACIC ROBOTS, DYNJ908777B
Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential consequences associated with detachment of fragments from valve include foreign body in patient's tracheobronchial tree, which may require intervention for removal. Other potential consequences include inflammatory response, hypoxia, and prolongation of procedure.
Medline kits containing Olympus biopsy valves: 1. BRONCHOSCOPY, DYNJ900898I D...
Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential consequences associated with detachment of fragments from valve include foreign body in patient's tracheobronchial tree, which may require intervention for removal. Other potential consequences include inflammatory response, hypoxia, and prolongation of procedure.
ENFIT G-TUBE CONNECTOR, MEDLINE Item No. ENFIT1010GC
Connectors were not manufactured to required dimensional specifications and may not form a proper seal with ENFit-style devices, which could lead to leakage. Leakage may result in delayed care and fluid loss. Additional consequences may also occur if user over-tightens the connector to stop the leakage, including additional clinical intervention, risk of infection, patient discomfort, and prolonged recovery process.
Airway Exam Kit, DYKE1796
Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential consequences associated with detachment of fragments from valve include foreign body in patient's tracheobronchial tree, which may require intervention for removal. Other potential consequences include inflammatory response, hypoxia, and prolongation of procedure.
Brand Name: da Vinci S, Si Tenaculum Forceps Instrument Product Name: da Vinci ...
Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments
Paradigm Insulin Pump (MMT-712, MMT-715)
All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
Brand Name: da Vinci S, Si Double Fenestrated Grasper Instrument Product Name: ...
Due to increased complaints for broken/frayed grip cables for reusable instruments.
CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: 354-9113, ...
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
Burlington Medical, BAT (Breast, Axilla and Thyroid) Coverage.
Potential for attenuation degradation over time, decreasing the lifespan.
Cardinal Health Monoject Tuberculin Syringe, 1 mL Luer Lock, Catalog Number 1180...
The outer packaging and blister pack labeling identify the product as 1mL Luer Lock Tuberculin Syringe (Product Code 1180100777), however the syringes contained within the packages are U-100 Insulin syringes.
MiniMed 630G Insulin Pump (MMT-1714, MMT-1715, MMT-1754, MMT-1755)
All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
Burlington Medical, Half Aprons.
Potential for attenuation degradation over time, decreasing the lifespan.
Burlington Medical, Blockers.
Potential for attenuation degradation over time, decreasing the lifespan.
Allura Xper FD20/20 OR Table; System Code: 722039;
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
Burlington Medical, Vest
Potential for attenuation degradation over time, decreasing the lifespan.
Brand Name: Finesse BTK Multicath Product Name: Injectable Angioplasty Balloon ...
Potential for the balloon in the device to not meet burst specifications.
ALLURA Xper FD10F; System Code: 722002;
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
eTRAX Needle System Starter Kit 16G(for Aurora Trackers), Part Number 667-151
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
MiniMed 640G Insulin Pump (MMT-1711, MMT-1712, MMT-1751, MMT-1752)
All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
MiniMed 530G Insulin Pump (MMT-551, MMT-751)
All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
Paradigm REAL-Time Revel Insulin Pump (MMT-523, MMT-723)
All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.