2019 Medical Device Recalls

The list below contains recalls that were issued in 2019.

2019 Medical Device Recalls

Device Name Date

Medtronic Recalls 6 French Sherpa NX Active Guide Catheters Due to Separation and Fragmentation Issue (/medical- 10/08/19
devices/medical-device-recalls/medtronic-recalls-6-french-sherpa-nx-active-guide-catheters-due-separation-and-
fragmentation-issue)

Allergan Recalls Natrelle Biocell Textured Breast Implants Due to Risk of BIA-ALCL Cancer (/medical-devices/medical- 09/12/19
device-recalls/allergan-recalls-natrelle-biocell-textured-breast-implants-due-risk-bia-alcl-cancer)

Edwards Lifesciences, LLC, Recalls SAPIEN 3 Ultra Delivery System Due to Burst Balloons During Surgery, Which May 08/22/19
Result in Vascular Injury, Bleeding, or Surgical Intervention (/medical-devices/medical-device-recalls/edwards-
lifesciences-llc-recalls-sapien-3-ultra-delivery-system-due-burst-balloons-during-surgery)

Medline Industries, Inc., Recalls Centurion Medical Products' Primary Warmer Pack and Primary Set Pack Containing 08/21/19
Becton Dickinson Alaris Pump Model 8100 Infusion Sets Due to Potential for Tube Collapse that May Cause
Unintended Delivery or Faster than Expected Delivery of Medication (/medical-devices/medical-device-
recalls/medline-industries-inc-recalls-centurion-medical-products-primary-warmer-pack-and-primary-set-pack)

Medline Industries, Inc., Recalls Centurion Medical Products' Primary Warmer Pack Containing Vyaire Medical enFlow 08/21/19
Fluid Warming Disposable Cartridge Due to Potential Risk of Exposure to Elevated Levels of Aluminum (/medical-
devices/medical-device-recalls/medline-industries-inc-recalls-centurion-medical-products-primary-warmer-pack-
containing-vyaire)

Fresenius Kabi Recalls Volumat MC Agilia Infusion Pump and Vigilant Agilia Drug Library Due to a "Low Priority" "Keep 08/12/19
Vein Open (KVO), End of Infusion" Alarm and Multiple Software Errors (/medical-devices/medical-device-
recalls/fresenius-kabi-recalls-volumat-mc-agilia-infusion-pump-and-vigilant-agilia-drug-library-due-low)

Abbott (Formerly St. Jude Medical Inc.), Recalls Ellipse Implantable Cardioverter De brillators Due to Exposed 08/05/19
Aluminum Wires That May Prevent De brillation Therapy (/medical-devices/medical-device-recalls/abbott-formerly-st-
jude-medical-inc-recalls-ellipse-implantable-cardioverter-de brillators-due)

QIAGEN Recalls Filter Tips for use with the QIAsymphony SP/AS Instruments Due to Potential to Leak, Which May 08/02/19
Result in Delayed or Inaccurate Results (/medical-devices/safety-communications/qiagen-recalls- lter-tips-use-
qiasymphony-spas-instruments-due-potential-leak-which-may-result)

Centurion Medical Products Recalls Airway Kit containing Sheridan® Endotracheal Tubes Due to Potential for the 08/02/19
Tube Connector to Dislodge, Which May Result in Disconnection of the Patient from the Breathing Circuit (/medical-
devices/safety-communications/centurion-medical-products-recalls-airway-kit-containing-sheridanr-endotracheal-
tubes-due-potential)

Datascope/Getinge Recalls Cardiosave Hybrid, Cardiosave Rescue, CS300 and CS100/100i Intra-Aortic Balloon 07/23/19
Pumps (IABP) Due to Potential Battery Failure (/medical-devices/medical-device-recalls/datascopegetinge-recalls-
cardiosave-hybrid-cardiosave-rescue-cs300-and-cs100100i-intra-aortic)

Becton Dickinson (BD) Recalls Alaris Infusion Sets for the Alaris Pump Model 8100 Due to Potential for Tube Collapse 07/18/19
that May Cause Unintended Delivery or Faster than Expected Delivery of Medication (/medical-devices/medical-
device-recalls/becton-dickinson-bd-recalls-alaris-infusion-sets-alaris-pump-model-8100-due-potential-tube-collapse)
Device Name Date

Becton Dickinson (BD) (CareFusion 303, Inc.) Recalls Alaris Pump Module Model 8100 Bezel Assembly Which Could 07/18/19
Result in Free Flow, Over-Infusion, Under-Infusion, or Interruption of Infusion (/medical-devices/medical-device-
recalls/becton-dickinson-bd-carefusion-303-inc-recalls-alaris-pump-module-model-8100-bezel-assembly-which)

Tele ex Recalls NEONATAL ConchaSmart Breathing Circuit Due to Circuit Cracks (/medical-devices/medical-device- 07/17/19
recalls/tele ex-recalls-neonatal-conchasmart-breathing-circuit-due-circuit-cracks)

GE Healthcare, LLC Recalls Giraffe Infant Warmers and Panda i-Res Infant Warmers Due to Bedside Panels and Latch 07/12/19
Areas Cracking or Breaking (/medical-devices/medical-device-recalls/ge-healthcare-llc-recalls-giraffe-infant-warmers-
and-panda-i-res-infant-warmers-due-bedside-panels)

Hamilton Medical AG Recalls Hamilton-G5 Ventilators Due to Potential for Sporadic Error Message Resulting in the 07/12/19
Ventilator to Cease Ventilation and Enter Ambient State (/medical-devices/medical-device-recalls/hamilton-medical-
ag-recalls-hamilton-g5-ventilators-due-potential-sporadic-error-message-resulting)

Becton Dickinson & Company (BD) Recalls SmartSite Syringe Administration Set Due to Risk of Leaks (/medical- 07/01/19
devices/medical-device-recalls/becton-dickinson-company-bd-recalls-smartsite-syringe-administration-set-due-risk-
leaks)

Edwards Lifesciences Recalls the IntraClude Intra-Aortic Occlusion Device Due to Risk of Balloon Rupture (/medical- 07/01/19
devices/medical-device-recalls/edwards-lifesciences-recalls-intraclude-intra-aortic-occlusion-device-due-risk-balloon-
rupture)

Vyaire Medical Recalls the enFlow Fluid Warming System Disposable Cartridges Due to Potential Risk of Exposure to 06/27/19
Elevated Levels of Aluminum Exposure to Patients (/medical-devices/medical-device-recalls/vyaire-medical-recalls-
en ow- uid-warming-system-disposable-cartridges-due-potential-risk-exposure)

Tele ex Medical Recalls the Hudson RCI Sheridan and Sheridan Endotracheal Tubes Due to Risk of the Sheridan 06/21/19
Connector Disconnecting from the Breathing Circuit (/medical-devices/medical-device-recalls/tele ex-medical-
recalls-hudson-rci-sheridan-and-sheridan-endotracheal-tubes-due-risk-sheridan)

Cook Incorporated Recalls Advance Enforcer 35 Focal Force PTA Balloon Catheter Due to Balloons Bursting Below the 06/18/19
Rated Burst Pressure (/medical-devices/medical-device-recalls/cook-incorporated-recalls-advance-enforcer-35-focal-
force-pta-balloon-catheter-due-balloons-bursting)

Terumo Medical Corporation Recalls SOLOPATH® Balloon Expandable TransFemoral System and Re-Collapsible 05/30/19
Balloon Access System Due to Dislodgement of the Fairing Tip from the Sheath (/medical-devices/medical-device-
recalls/terumo-medical-corporation-recalls-solopathr-balloon-expandable-transfemoral-system-and-re)

lntegra LifeSciences Recalls the LimiTorr Volume Limiting CSF Drainage System and the MoniTorr ICP External CSF 05/24/19
Drainage and Monitoring System Due to Possible Breakage of the LimiTorr Transducer and MoniTorr Panel Mount
Stopcock (/medical-devices/medical-device-recalls/lntegra-lifesciences-recalls-limitorr-volume-limiting-csf-drainage-
system-and-monitorr-icp-external)

Edwards Lifesciences LLC Recalls EV1000 Clinical Platforms Due to Electrical Short Circuit Which May Cause the 05/24/19
Device to Stop Working or Catch Fire (/medical-devices/medical-device-recalls/edwards-lifesciences-llc-recalls-
ev1000-clinical-platforms-due-electrical-short-circuit-which-may)

Beckman Coulter Life Sciences Recalls DxH800 and DxH600 and DxH 900 Hematology Analyzers Due to Risk of 05/23/19
Inaccurate Results (/medical-devices/medical-device-recalls/beckman-coulter-life-sciences-recalls-dxh800-and-
dxh600-and-dxh-900-hematology-analyzers-due-risk)

Ethicon Recalls Circular Staplers for Insu cient Firing and Failure to Completely Form Staples (/medical- 05/16/19
devices/medical-device-recalls/ethicon-recalls-circular-staplers-insu cient- ring-and-failure-completely-form-staples)
Device Name Date

Alpha Omega Engineering Recalls Neuro Omega System Due to Design Flaw Which May Cause Signi cant Tissue 05/06/19
Harm (/medical-devices/medical-device-recalls/alpha-omega-engineering-recalls-neuro-omega-system-due-design-
aw-which-may-cause-signi cant)

Edwards Lifesciences Recalls Miller and Fogarty Atrioseptostomy Dilation Catheters Due to Balloon De ation, 04/26/19
Fragmentation and Detachment Issue (/medical-devices/medical-device-recalls/edwards-lifesciences-recalls-miller-
and-fogarty-atrioseptostomy-dilation-catheters-due-balloon)

Brainlab AG Recalls Spine & Trauma 3D Navigation Due to Inaccurate Display That May Result in User 04/15/19
Misinterpretation (/medical-devices/medical-device-recalls/brainlab-ag-recalls-spine-trauma-3d-navigation-due-
inaccurate-display-may-result-user)

O-Two Medical Technologies, Inc. Recalls o_two e700, e600 and e500 Automatic Transport Ventilators Due to 04/03/19
Potential Risk of Fire (/medical-devices/medical-device-recalls/o-two-medical-technologies-inc-recalls-o_two-e700-
e600-and-e500-automatic-transport-ventilators-due)

Cook Medical Inc. Recalls Transseptal Needle Due to Risk of Detached Plastic Fragments (/medical-devices/medical- 03/18/19
device-recalls/cook-medical-inc-recalls-transseptal-needle-due-risk-detached-plastic-fragments)

RVO 2.0, Inc. Recalls Raindrop Near Vision Inlay Due to Risk of Increased Risk of Corneal Haze (/medical- 03/05/19
devices/medical-device-recalls/rvo-20-inc-recalls-raindrop-near-vision-inlay-due-risk-increased-risk-corneal-haze)

Physio-Control Recalls LIFEPAK15 Monitor/De brillator Due to Risk of Device "Lockup" (Freezing) (/medical- 02/27/19
devices/medical-device-recalls/physio-control-recalls-lifepak15-monitorde brillator-due-risk-device-lockup-freezing)

Medtronic, Inc. Recalls Dual Chamber Implantable Pulse Generators (IPGs) Due to Possible Circuit Error (/medical- 02/22/19
devices/medical-device-recalls/medtronic-inc-recalls-dual-chamber-implantable-pulse-generators-ipgs-due-possible-
circuit-error)

Edwards Lifesciences Recalls Swan-Ganz Thermodilution Catheter Due to Incorrect Assembly Causing Reversal of 02/15/19
Lumens (/medical-devices/medical-device-recalls/edwards-lifesciences-recalls-swan-ganz-thermodilution-catheter-
due-incorrect-assembly-causing)

Medex Cardio-Pulmonary, doing business as Smiths Medical, Recalls Sterile Saline and Sterile Water for Inhalation 02/05/19
Due to Potential Exposure to Infectious Agents as a Result of Leaking Containers (/medical-devices/medical-device-
recalls/medex-cardio-pulmonary-doing-business-smiths-medical-recalls-sterile-saline-and-sterile-water)

Terri c Care, LLC. / Medex Supply Recalls CoaguChek XS PT Test Strips Used to Monitor Blood Thinner Warfarin Due 02/04/19
to Inaccurate Test Results (/medical-devices/medical-device-recalls/terri c-care-llc-medex-supply-recalls-coaguchek-
xs-pt-test-strips-used-monitor-blood-thinner)

West Pharmaceutical Services Inc. Recalls Vial2Bag Fluid Transfer Systems Due to Potential Malfunctions (/medical- 02/01/19
devices/medical-device-recalls/west-pharmaceutical-services-inc-recalls-vial2bag- uid-transfer-systems-due-
potential-malfunctions)

Draeger Medical Recalls Breathing Circuits and Anesthesia Sets (/medical-devices/medical-device-recalls/draeger- 01/25/19
medical-recalls-breathing-circuits-and-anesthesia-sets)

Medtronic Recalls Synergy Cranial Software and Stealth Station S7 Cranial Software Due to Inaccuracies Displayed 01/08/19
During Surgical Procedures (/medical-devices/medical-device-recalls/medtronic-recalls-synergy-cranial-software-and-
stealth-station-s7-cranial-software-due-inaccuracies)