February 2019

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

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.

Who May be Affected
Hospitals and health care professionals using Medtronic’s Dual Chamber Implantable Pulse Generators to provide pacing support to treat patients with bradycardia.
Patients and caregivers of patients receiving pacing support using a Medtronic Dual Chamber Implantable Pulse Generator.

Macleods Pharmaceuticals Limited Issues Voluntary Nationwide Consumer Level Recall of One Lot (BLM 715A) of Losartan Potassium/Hydrochlorothiazide Combination Tablets 100mg/25mg Due to detection of NDEA (N-Nitrosodiethylamine) Impurity

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.