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February 2019

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  • Medtronic, Inc. Recalls Dual Chamber Implantable Pulse Generators (IPGs) Due to Possible Circuit Error

    Friday, March 1, 2019

    The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death

    Recalled Product(s):

    • Medtronic, Inc. Dual Chamber Implantable Pulse Generators (IPGs)
    • Model Names:
      • Adapta, Versa, Sensia, Relia, Attesta, Sphera, and Vitatron A, E, G, Q series
    • Manufacturing Dates: March 2, 2017, to December 18, 2018
    • Distribution Dates: March 6, 2017, to January 7, 2019
    • Devices Recalled in the U.S.: 13,440

    Device Use

    Medtronic’s Dual Chamber Implantable Pulse Generators (IPGs) are implanted cardiac pacemakers used to provide stimulation to increase heart rate in patients with a slow heart rhythm (bradycardia) or no heart rhythm. The pulse generator is the small implanted unit containing the battery and other electronic parts. The pulse generator must be used with insulated electrode wires called leads. These devices are designed to be used in addition to routine clinical monitoring by a health care professional.

    Reason for Recall

    Medtronic is recalling its dual chamber IPGs due to the possibility of a software error that can result in a lack of pacing. Patients and physicians cannot predict whether and when this software error might occur. A lack of pacing could result in patients experiencing slow heart beating, low blood pressure, and symptoms such as light headedness, fainting, and even death.

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  • Physio-Control Recalls LIFEPAK15 Monitor/Defibrillator Due to Risk of Device "Lockup" (Freezing)

    Friday, March 1, 2019

    The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death

    Recalled Product(s)

    • Physio-Control, Inc. LIFEPAK15 Monitor/Defibrillator (LP15)
    • Model: LIFEPAK 15 Monitor/Defibrillators with Printed Circuit Board Assembly (PCBA) part no. 3206834-011 or 3206834-012
    • Serial/Lot Numbers:  See "Full List of Affected Devices"
    • Manufacturing Dates: March 21, 2013, to July 18, 2016
    • Distribution Dates: March 21, 2013, to July 18, 2016
    • Devices Recalled in the U.S.: 8,164

    Device Use

    Physio-Control's LIFEPAK 15 Monitor/Defibrillator is used to deliver lifesaving electrical shocks to people with sudden cardiac arrest, a medical condition in which the heart suddenly and unexpectedly stops beating. Defibrillation electrodes are connected to the defibrillator to help the device analyze a patient's heart rhythm and deliver an electrical shock to restore normal heart rhythm when needed. The LIFEPAK 15 monitor displays the patient's heart rhythm so the health care provider can study the heart's electrical activity.

    The LIFEPAK 15 is designed to be used only by trained medical personnel during ground transport of a patient.

    Reason for Recall

    Physio-Control is recalling its LIFEPAK 15 Monitor/Defibrillator because the device may "lockup" (freeze) after a shock is delivered. When this occurs, the device's monitor display goes blank and there is no response from the keypad or the device although the device's LED lights remain on and indicates the device still has power.

    Once the LIFEPAK 15 freezes, it cannot provide defibrillation therapy until the device is reset by restarting the device or removing and reinserting all connected power sources. The resulting delay in delivering a shock could and has resulted in serious patient injury including death.

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  • Macleods Pharmaceuticals Limited Issues Voluntary Nationwide Consumer Level Recall of One Lot (BLM 715A) of Losartan Potassium/Hydrochlorothiazide

    Friday, March 1, 2019

    Macleods Pharmaceuticals Limited is voluntarily recalling one lot of Losartan Potassium/Hydrochlorothiazide combination tablets 100mg/25mg to the consumer level due to the detection of trace amounts of an unexpected impurity (NDEA) found in finished product manufactured with active pharmaceutical ingredient made by Hetero Labs Limited.

    Risk Statement: The impurity detected is N-nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification. Macleods is recalling one lot of Losartan Potassium/Hydrochlorothiazide combination tablets 100mg/25mg that contains NDEA above the interim acceptable daily intake levels released by the FDA.

    To date, Macleods Pharmaceuticals Limited has not received any reports of adverse events related to this recall.

    Losartan Potassium/Hydrochlorothiazide combination tablets are indicated to treat hypertension and hypertensive patients with Left Ventricular Hypertrophy. Patients who are on Losartan Potassium/Hydrochlorothiazide combination tablets, USP should continue taking their medication, as the risk of harm to the patient's health may be higher if the treatment is stopped immediately without any alternative treatment.

    The product subject to recall is listed below and packaged in bottles. The product can be identified by checking the product name, manufacturer details and batch or lot number on the bottle containing these products.

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