MedFDAWatch
← Back to Medical Device Explorer

MEDTRONIC INC

FUSION · Ophthalmic

510(k): 10 Recall: 1 UDI: 14 MAUDE: 10 Class.: 66

Related Cybersecurity Alerts

Paragonix Technologies Inc. — Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System REF# PRGNX-8008-001
HIGH · FDA · 2026-07-20
Paragonix Technologies Inc. — Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System REF# PRGNX-8008-001
HIGH · FDA · 2026-07-20
CareFusion 303, Inc. — BD Pyxis MedStation ES, REF: 323, BD Pyxis MedStation ES 7 Drawer Auxiliary, REF: 324, BD Pyxis M
HIGH · FDA · 2025-11-20
CareFusion 303, Inc. — BD Pyxis MedStation ES, REF: 323, BD Pyxis MedStation ES 7 Drawer Auxiliary, REF: 324, BD Pyxis
HIGH · FDA · 2025-11-20
CareFusion 303, Inc. — Description/REF: BD PYXIS MEDBANK MINI 1FH-1FM/169-137, BD PYXIS MEDBANK MINI 4HM/169-113, BD PY
HIGH · FDA · 2025-07-10
CareFusion 303, Inc. — Product Name [REF]: Supply Server, CCE Enterprise SW Site License (2-5), BD Pyxis Logistics [806], B
HIGH · FDA · 2025-05-08
ICU Medical, Inc. — LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1 and v2.2
HIGH · FDA · 2025-05-02
CareFusion 303, Inc. — BD PYXIS MEDBANK (Name, REF): MEDPASS MODULE, 139088-01; MINI 1FH-1FM, 169-137; MINI 1HH-1FH-1HM, 16
HIGH · FDA · 2025-03-11
CareFusion 303, Inc. — BD PYXIS MEDBANK (Name, REF): MEDPASS MODULE, 139088-01; MINI 1FH-1FM, 169-137; MINI 1HH-1FH-1HM,
HIGH · FDA · 2025-03-11
CareFusion 303, Inc. — BD Pyxis: MedFlex, REF: 1119-00; MedBank Tower REF: 1145-00; MedBank MedPass, REF: 139088-01 and ass
HIGH · FDA · 2025-01-10

510(k) Clearances (10)

Affinity Fusion™ Oxygenator System
2023-04-06

Substantially Equivalent

Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface, Affinity NT Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Balance Biosurface
2019-04-12

Substantially Equivalent

Affinity Pixie Oxygenator with Balance Biosurface, Affinity Pixie Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Pixie Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and Cortiva BioActive Surface
2017-11-20

Substantially Equivalent

Affinity Fusion Oxygenator with Balance Biosurface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Fusion Oxygenator with Cortiva Biosurface, Affinity Fusion Oxygenator with Cortiva BioActive Surface & Cardiotomy/Venous Reservoir
2017-10-25

Substantially Equivalent

Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda BioActive Surface
2014-10-24

Substantially Equivalent

AFFINITY FUSION CARDIOTOMY/VENOUS RESERVOIR WITH BALANCE BIOSURFACE
2013-10-28

Substantially Equivalent

AFFINITY FUSION OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND CARMEDA BIOACTIVE SURFACE
2013-01-22

Substantially Equivalent

AFFINITY FUSION CARDIOTOMY/VENOUS RESERVIOR WITH BALANCE BIOSURFACE MODEL BB841, AFFINITY FUSION CARDIOTOMY/ VENOUS RESE
2013-01-09

Substantially Equivalent

AFFINITY FUSION OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND BALANCE BIOSURFACE MODEL BB811
2012-12-14

Substantially Equivalent

AFFINITY FUSION RECIRCULATION LINE MODEL RCL841
2012-10-19

Substantially Equivalent

Recalls (1)

Affinity Fusion" Oxygenator with Integrated Arterial Filter, Affinity Fusion cardiotomy/Venous Reservoir, Perfusion Tubing Packs The Affinity Fusion Oxygenator with Integrated Arterial Filter with or without the Cardiotomy/Venous Reservoir with Balance1 Biosurface is intended for use in an extracor
2016-11-16

Medtronic is initiating a voluntary product recall for specific lot numbers of the Affinity Fusion Oxygenators with Balance1 Biosurface. These are distributed as stand-alone devices, or as a combination unit with the Affinity Fusion Cardiotomy/Venous Reservoir, or as part of tubing packs. Medtronic has identified an out-of-specification condition exhibiting additional plastic (flash) in the arteri…

UDI Registrations (14)

Affinity Fusion™

FPA FUSION OXY CB811 CORTIVA 2L

Affinity Fusion®

OXY/CVR COMBO BB841 FUSION W/BALANCE

Affinity Fusion®

OXYGENATOR BB811 FUSION W/BALANCE

Affinity Fusion™

OXYGENATOR BB811 FUSION BALANCE 2L

Affinity Fusion®

OXY/CVR COMBO BB841 US BALANCE

Affinity Fusion®

OXYGENATOR BB811 W/BALANCE US

Affinity Fusion™

RECIR LINE RCL841 FOR FUSION OXY/CVR

Affinity Fusion™

OXYGENATOR CB811 FUSION CORTIVA US

Affinity Fusion™

OXY/CVR COMBO BB841 FUSION BALANCE 2L

Affinity Fusion®

OXY/CVR COMBO CB841 FUSION W/CARMEDA

Affinity Fusion®

OXY/CVR COMBO BB841 FUSION W/BALANCE

Affinity Fusion™

OXY/CVR COMBO CB841 FUSION CORTIVA US

Affinity Fusion™

FPA FUSION CB841 CORTIVA US 2L

Affinity Fusion®

OXYGENATOR CB811 FUSION W/CARMEDA

MAUDE Adverse Events (10)

Malfunction
20250319
Malfunction
20241126
Malfunction
20240724
Malfunction
20240513
Malfunction
20240509
Malfunction
20231213
Malfunction
20231115
Malfunction
20231106
Malfunction
20210913
Malfunction
20200730

FDA Classification (66)

Clip, Iris Retractor

Ophthalmic

Dilator, Expansive Iris (Accessory)

Ophthalmic

Implant, Eye Valve

Ophthalmic

Hydrophilic Re-Coating Solution

Ophthalmic

Fixation, Vision Training, Binocular

Ophthalmic

Collagen Corneal Shield

Ophthalmic

Pupillometer, Manual

Ophthalmic

Aid, Vision, Electronic, Ac-Powered

Ophthalmic

Photostimulator, Ac-Powered

Ophthalmic

Tubing, Replacement, Phacofragmentation Unit

Ophthalmic

Device, Fixation, Ac-Powered, Ophthalmic

Ophthalmic

Corneal Inlay Inserter Handle

Ophthalmic

Vitrectomy, Instrument Cutter

Ophthalmic

Sterilizer, Tonometer

Ophthalmic

Camera, Ophthalmic, General-Use

Ophthalmic

Euthyscope, Ac-Powered

Ophthalmic

Projector, Ophthalmic

Ophthalmic

Instrument, Measuring, Stereopsis

Ophthalmic

Lens, Intraocular, Toric Optics

Ophthalmic

Drum, Opticokinetic

Ophthalmic

Expander, Tissue, Orbital

Ophthalmic

Ruler, Nearpoint (Punctometer)

Ophthalmic

Lens, Fundus, Hruby, Diagnostic

Ophthalmic

Lens, Contact, For Color Vision Deficiency

Ophthalmic

Retractor, Ophthalmic

Ophthalmic

Sunglasses (Non-Prescription Including Photosensitive)

Ophthalmic

Intraocular Lens

Ophthalmic

Applicator, Negative Pressure, External, Ocular

Ophthalmic

Tester, Color Vision

Ophthalmic

Keratome, Water Jet

Ophthalmic

Clip, Lens, Trial, Ophthalmic

Ophthalmic

Maxwell Spot, Ac-Powered

Ophthalmic

Cannula, Ophthalmic

Ophthalmic

Unit, Cryophthalmic

Ophthalmic

Topographer, Corneal, Ac-Powered

Ophthalmic

Stand, Instrument, Ophthalmic, Battery Powered

Ophthalmic

Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-Powered

Ophthalmic

Esthesiometer, Ocular

Ophthalmic

Burr, Corneal, Manual

Ophthalmic

Ocular Peg, Exempt

Ophthalmic

Lenses, Soft Contact, Daily Wear

Ophthalmic

System, Monitoring, For Progress Of Labor

Ophthalmic

Intranasal Electrostimulation Device

Ophthalmic

Lens, Contact (Other Material) - Daily

Ophthalmic

Retinoscope, Ac-Powered

Ophthalmic

Ophthalmoscope, Battery-Powered

Ophthalmic

Engine, Trephine, Accessories, Ac-Powered

Ophthalmic

Keratome, Ac-Powered

Ophthalmic

Aid, Vision, Optical, Battery-Powered

Ophthalmic

Photokeratoscope, Battery Powered

Ophthalmic

Eyelid Thermal Pulsation System

Ophthalmic

Screen, Tangent, Target, Battery-Powered

Ophthalmic

Marker, Ocular

Ophthalmic

Ophthalmoscopes, Replacement Batteries, Hand-Held

Ophthalmic

Light, Headband, Surgical

Ophthalmic

Prism, Fresnel, Ophthalmic

Ophthalmic

Device, Measuring, Lens Radius, Ophthalmic

Ophthalmic

Keratoprosthesis, Permanent Implant

Ophthalmic

Preamplifier, Ac-Powered, Ophthalmic

Ophthalmic

System, In-Office Tinting, Contact Lenses

Ophthalmic

Test, Spectacle Dissociation, Ac-Powered (Lancaster)

Ophthalmic

Sponge, Ophthalmic

Ophthalmic

Forceps, Ophthalmic

Ophthalmic

Weights, Eyelid, External

Ophthalmic

Table, Instrument, Powered, Ophthalmic

Ophthalmic

Engine, Trephine, Accessories, Battery-Powered

Ophthalmic