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…
Read the official notice →- Date
- 2022-12-28
- Country
- United States
- Brand
- Heartware
- Product
- HeartWare Model 1100
- Classification
- Class II
- Units
- Worldwide distribution.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 → - 2022-08-24
- US
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…
FDA · DeviceHeartware, Inc.Worldwide distribution. US nationwide, Japan, Indonesia, Brazil, Chile,…Official notice → - 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
- 2022-12-28
- US
Baxter Healthcare Corporation recalls Revaclear 400 Dialyzer. Product Code: 114749M. Not distributed in the USA. Used to treat chronic and acute renal failure by…
Potential for Internal Blood Leaks due to a twisted gasket in the dialyzer
FDA · DeviceBaxter Healthcare CorporationWorldwide distribution. US Nationwide including Guam and St. Thomas USVI;…Official notice → - US
GE Medical Systems, LLC recalls Vivid S6 ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes,…
Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire.
FDA · DeviceGE Medical Systems, LLCWorldwide - US Nationwide distribution including in the states of AK, AL, AR,…Official notice → - US
Medical Action Industries, Inc. 306 recalls Medical Action INDUSTRIES INC. Port a Cath Kit REF 58647D, cardiac catheter introduction kit
XXX
FDA · DeviceMedical Action Industries, Inc. 306US Nationwide distribution in the state of VA.Official notice → - US
Companion Medical, Inc. recalls InPen Diabetes Management App, part of the InPen System, REF: MMT-105ELBLNA, MMT-105ELGYNA, MMT-105ELPKNA, MMT-105ELPKNA, MMT-105NNBLNA,…
Diabetes management app may crash immediately upon opening, while using the app and/or while app is running in the background, which may lead to inability to use the app. An error message may be displayed indicating…
FDA · DeviceCompanion Medical, Inc.US Nationwide distribution including in the states of CA, NY, MT, OH, IN, MN,…Official notice → - US
Abbott Molecular, Inc. recalls Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096
Reports of an increase in reactive negative controls and false positive results with certain lots of Alinity M Resp-4-Plex AMP kits.
- US
NuVasive Inc recalls X-CORE 2 Ti Core, Static. Part of the NuVasive X-Core Expandable VBR System used with spinal fixation.
Potential that insert will be unable to disengage from the vertebral body replacement device/implant
FDA · DeviceNuVasive IncWorldwide - U.S. Nationwide distribution including in the states of NC, CA,…Official notice →