27 medical supply recalls in 2021

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Becker's Hospital Review has reported on 27 medical supply recalls in 2021, as of June 25: 

  1. Philips recalls 3.5M ventilation devices, cites potential cancer risk
    Philips has recalled roughly 3.5 million ventilation devices after finding a defect that could cause cancer. The ventilators use polyester-based polyurethane sound abatement foam, which has the potential to degrade into particles that could be ingested or inhaled and have toxic and carcinogenic effects.

  1. Innova Medical Group recalls unauthorized COVID-19 test
    Innova Medical Group has recalled at least 77,339 of its COVID-19 antigen tests after the FDA discovered the company was selling the test without its approval and that it carries the risk of false positive and false negative results.

  2. Lepu Medical Technology recalls COVID-19 antigen test
    Lepu Medical Technology has recalled its COVID-19 rapid antigen test after finding it's likely to produce false results. The test wasn't authorized, cleared or approved for marketing or distribution in the U.S.

  3. Step-Har Medical recalls infusion pump
    Step-Har Medical, a biomedical repair company in Fountain Valley, Calif., has recalled the Alaris infusion pump after finding a component of the device may crack or separate, leading to an inaccurate delivery of fluids to patients. The pump is used to deliver medications, nutrients, blood and other therapies into a person's body in controlled amounts.

  4. Smiths Medical recalls insulin syringes
    Smiths Medical, a St. Paul, Minn.-based medical devicemaker, has recalled several lots of insulin syringes after discovering some had skewed measurement markings.

  5. Medical Action Industries recalls supply kits
    Medical Action Industries has recalled more than 8,000 of its medical convenience kits, which include supplies used for routine medical care, as they include a Chloraprep applicator made by Becton Dickinson, recalled because of the risk of contamination with the fungus Aspergillus penicillioides.

  6. Boston Scientific recalls two types of stents
    Boston Scientific Corp. has recalled its VICI SDS and VICI RDS venous stent systems, which are used to treat obstructions in blocked venous veins, after finding the stents have the potential to migrate or move from where they are initially implanted.

  7. Abbott recalls nearly 62K pacemakers
    Abbott has recalled nearly 62,000 pacemakers after finding they have the potential to short circuit.

  8. Medtronic recalls instructions for its heart pump device
    Medtronic has recalled the instructions for its HeartWare Ventricular Assist Device System, which helps the heart pump blood to the rest of the body, to provide updated instructions that address various safety issues.

  1. Pacific Medical Group recalls infusion pump
    Pacific Medical Group is recalling the Alaris infusion pump module model 8100, used to deliver fluids such as medications, nutrients and blood into a person's body in controlled amounts. The recall is because a component of the device may crack or separate, leading to inaccurate delivery of fluids to patients.

  1. Cordis recalls carotid artery device
    Cordis has recalled its Precise PRO Rx US Carotid System, a device used to treat patients with narrowed carotid arteries. The recall is due to a risk of separation in the delivery system, which could cause a stroke.

  2. BD recalls ChloraPrep applicator
    Becton, Dickinson and Co. is recalling its ChloraPrep applicator, found defective. In some lots, the applicator end cap was improperly secured because of a manufacturing error, which can result in broken glass and solution dropping out of the applicator once activated.

  1. Medtronic recalls blood-pumping console
    Medtronic is recalling a blood-pumping console after reports of electrical failure causing the device to stop. The device is used to pump and return blood to someone during cardiopulmonary bypass, a procedure that temporarily takes over the function of the heart and lungs during surgery.

  1. CareFusion recalls Alaris pump module
    CareFusion is recalling the Alaris pump module — an infusion pump and vital signs monitor —  because of a risk of the keypad lifting up when fluid enters, which could lead to keys becoming unresponsive or stuck. This could lead to an infusion delay or prevent clinicians from changing fluid or medication infusions on the affected devices.

  1. Medtronic recalls heart pump
    Medtronic has recalled its HeartWare Ventricular Assist Device, used to help the heart continue to pump blood into the rest of the body, because of the risk of wear and tear to the connector plug, which could damage the controller port metal pins. Damaged controller ports may prevent the power and data cables from being connected to the controller and lead to a full or partial stop of the pump. There have been 12 deaths and eight injuries related to the recall.

  1. Medtronic recalls several defibrillators due to risk of shortened battery life
    Medtronic has recalled its Evera, Viva, Brava, Claria, Amplia, Compia, and Visia defibrillators, as well as its cardiac resynchronization therapy device, due to an unexpected and rapid decrease in battery life.

  2. Smisson-Cartledge Biomedical recalls IV fluids device
    Smisson-Cartledge Biomedical has recalled its ThermaCor Disposable sets, a fluid delivery device for IV bags, after finding part of the device may leak aluminum into the fluids and expose patients to high levels of the metal.

  3. Medtronic recalls oxygenator and venous reservoir
    Medtronic has recalled its Affinity Pixie oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface — devices used in newborns, infants and small pediatric patients during cardiopulmonary bypass — after finding potentially elevated levels of harmful bacteria called endotoxins.

  1. Combat Medical Systems recalls convenience kits, cites possible needle damage
    Combat Medical Systems has recalled its convenience kits, which are used by military medical personnel to transfuse donor blood to patients on the battlefield, after discovering the needle in the blood pack may bend or disconnect from the blood bag.

  2. ACIST Medical Systems recalls ultrasound catheter
    ACIST Medical Systems has recalled its Kodama intravascular ultrasound catheter after finding the O-ring housing tubing may squeeze and damage the O-ring, which could cause the O-ring to break free and enter the patient's artery during use, which could cause a heart attack or stroke.

  3. Medtronic recalls heart pump device after 2 patient deaths
    Medtronic has recalled a heart pump device after discovering it sometimes failed to start or restart, an issue that led to two patient deaths.

  4. Medical devicemaker recalls patient lift after 2 deaths reported
    Hillrom, a medical devicemaker based in Chicago, has recalled its patient overhead lift device after multiple reports of serious injuries and two patient deaths.

  5. Boston Scientific recalls defibrillator
    Boston Scientific has recalled its EMBLEM S-ICD defibrillator after identifying that a manufacturing process may allow moisture to get inside the defibrillator and cause a short-circuit when it tries to deliver high-voltage shocks.

  6. Medtronic recalls thoracic stent graft after patient's death
    Medtronic is recalling its Valiant Navion thoracic stent graft system after discovering three patients in a clinical trial had stent fractures and a report of one patient death.

  7. Boston Scientific recalls aortic valve device
    Boston Scientific has recalled its LOTUS edge aortic valve system, saying the delivery system for the device is too complex. There's no safety issue for patients who currently have the device.

  8. Penumbra recalls JET 7 Xtra Flex catheter
    Penumbra has recalled its JET 7 Xtra Flex after finding the tip of the device is susceptible to damage during use. The FDA has received more than 200 adverse event reports related to the device, including deaths and serious injuries.

  1. Boston Scientific recalls cardiac device
    Boston Scientific has recalled its implantable defibrillator device after finding an increased risk of the device fracturing during use. 

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