Heartware, Inc. recalls HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE
Battery performance issues. Battery electrical faults render it unable to power the controller, unable to accept charge from the battery charger, and/or result in the battery to appear to remain charged while…
Read the official notice →- Date
- 2022-08-24
- Country
- United States
- Brand
- Heartware
- Product
- HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE
- Classification
- Class I
- Units
- Worldwide distribution. US nationwide, Japan, Indonesia, Brazil, Chile,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Heartware recalls
- 2023-12-13
USHeartware, Inc. recalls PUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1103
Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended…
- 2023-06-28
- US
Heartware, Inc. recalls HeartWare Ventricular Assist Device System. a) Monitor 1521US Explore Tech, b) Monitor 1521GB Explore Tech, c) Monitor 1521IL Explore…
Medtronic has identified that the logfiles downloaded from the recently updated Model 1521 monitors (Serial Numbers: MON4xxxxxx for OUS and MON5xxxxxx for US), are unable to be processed by the Autologs web portal.
FDA · DeviceHeartware, Inc.Worldwide - US Nationwide distribution in the states of TX, MO, VA, and the…Official notice → - 2022-12-28
- US
Heartware, Inc. recalls HeartWare Model 1100
Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Access to the driveline connector may be delayed, which…
- 2022-05-25
- US
Heartware, Inc. recalls HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1407DE Kit
Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instructions for Use, Patient Manual, and Emergency Responder Guide for the HeartWare Ventricular Assist Device (HVAD) system.
- 2022-03-16
- US
Heartware, Inc. recalls HeartWare Ventricular Assist Device (HVAD) System
Updated cleaning instructions are being provided for the Controller AC Adapter, DC Adapter, and Battery to provide clarity to avoid cleaning the power source connector pins, as this could remove the lubricant that is…
FDA · DeviceHeartware, Inc.Distribution throughout the United States. OUS distribution in Argentina,…Official notice →
Other drugs & medical recalls in the United States
- 2022-08-24
- US
Myolyn Inc. recalls Power electronic box, Part #AS-0066, subassembly for the MyoCycle MC-2.
Screws mounting an internal power supply may come loose during shipping resulting in increased risk of high voltage electrical shock.
FDA · DeviceMyolyn Inc.Distribution was made to AZ, CA, CT, FL, GA, ID, IL, KY, MA, MI, MN, MO, MN,…Official notice → - US
Abbott Molecular, Inc. recalls The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use.
Incorrect optical calibration
- US
ASO LLC recalls (1) CVS Health Sterile Surgical Pads, Cushion Comfort, packaged 12 pads 5 in. x 9 in. per box, ASO Item No. 781083, SKU 894111 (2) CVS…
The product falls apart during handling after removal from its primary packaging.
FDA · DeviceASO LLCWorldwide distribution - US Nationwide distribution in the states of AL, CA,…Official notice → - US
Akorn, Inc recalls PrednisoLONE Oral Solution USP, 15 mg per 5 mL, 240 ml bottle, Rx Only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. NDC: 50383-042-24
Defective Container: Product has incomplete induction seals.
- US
Aire-Master of America Inc recalls Common Sense Fragrance Free Hand Sanitizer, 250 Gallon Tote, Microbe Solutions, LLC, 344-5 Route 9, Suite 237, Lanoka Harbor, NJ 08734
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
- US
Nephron Sc Inc recalls Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL single dose vials, Rx Only, Nephron Pharmaceutical…
cGMP Deviations: deviations leading to potential cross-contamination.