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…
Read the official notice →- Date
- 2022-03-16
- Country
- United States
- Brand
- Heartware
- Product
- HeartWare Ventricular Assist Device (HVAD) System
- Classification
- Class II
- Units
- Distribution throughout the United States. OUS distribution in Argentina,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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…
- 2022-08-24
- 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.
Other drugs & medical recalls in the United States
- 2022-03-16
- US
Maquet Cardiovascular, LLC recalls HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR VASCULAR GRAFT- D: 7 mm; L: 60 cm Indicated for use in the replacement or repair of…
Outer labelling (HEMASHIELD GOLD Knitted Microvel Double Velour Bifurcated Vascular Graft, D: 16 x 8 mm; L: 40 cm) does not correspond to the (inner) sterile packaging labelling (HEMASHIELD GOLD Knitted Microvel Double…
FDA · DeviceMaquet Cardiovascular, LLCUS Nationwide distribution in the state of MO.Official notice → - US
Stryker Corporation recalls 1688 Camera Control Unit (CCU), Catalog number:1688010000. Used in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and…
A software defect in the camera control unit (CCU) will cause the image on the monitor to flip upside-down into an incorrect orientation. The potential of harms are conversion to open procedure, additional medical…
FDA · DeviceStryker CorporationWorldwide distribution. US nationwide including Puerto Rico. OUS: BR, AE, NL,…Official notice → - US
B. Braun Medical, Inc. recalls Dispensing Pins for Air Inlet Filter, Product Catalog No. 412005, DP2500 Dispensing Pin W/Valve. A valve for aspiration or injection of…
This lot may have an elevated risk of leakage from the Air-Inlet Filter of the device. Leakage of the Air-Inlet Filter may increase the risk of decreasing the dose of medication delivered to the patient, cause delays…
FDA · DeviceB. Braun Medical, Inc.US Nationwide distribution in the states of AZ, CA, FL, LA, MI, MO, MS, NC,…Official notice → - US
Philips North America Llc recalls Philips Allura Xper, UNIQ(Allura Xper system-China) Interventional Fluoroscopic X-ray System products with a Laird chiller WITHOUT an…
Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of the chiller. If this occurs the liquid may drip onto electrical components in the R cabinet located in the technical room,…
FDA · DevicePhilips North America LlcUS Nationwide Foreign: Argentina Austria Bangladesh Brazil Chile China Denmark…Official notice → - US
Carl Zeiss Meditec, Inc. recalls CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex
Optic nerve head angiography scan to be turned off due to its distribution without pre-market clearance.
FDA · DeviceCarl Zeiss Meditec, Inc.U.S Nationwide Distribution.: OH, CA, IN, AR, IA, LA, WI, OK, IL, OR, AL, KY,…Official notice → - US
Remel Inc recalls Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD format
There are lower than expected MICs for some gram negative species.