Medical device recalls
Recalls
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Spectranetics Corporation medical device recall: Intact Vascular Tack Endovascular System
Use of Tack Endovascular system, designed to treat acute dissections of inner wall or lining of an artery by tacking damaged tissue to inner luminal surface, could…
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Olympus Corporation of the Americas medical device recall: Olympus Single Use Guide Sheath Kits with the following product…
Potential for the radiopaque tip of the guide sheath component to disassociate and fall off into the patient.
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Max Mobility LLC medical device recall: Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC…
Due to faulty circuit board in speed control remote use in conjunction with a wheelchair power assist, their is a potential for lost of control of device potentially…
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Getinge Usa Sales Inc medical device recall: Vaporizer Sevoflurane
Sevoflurane used with the vaporizer may degrade to hydrogen fluoride, which could present a risk to patients or health care providers through inhalation and/or skin…
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ROi CPS LLC medical device recall: regard Item Number: 830106006
There is a potential for the Inline Controller to be using the spring out of specification causing a loss of positive pressure resulting in the Neo-Tee Resuscitator…
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Fresenius Kabi USA, LLC medical device recall: Ivenix Infusion System
Large Volume Pump Software, version 5.9.2 and earlier has potential for the following anomalies: 1. The pump may become nonfunctional if during an alarm condition the…
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MEDLINE INDUSTRIES, LP - Northfield medical device recall: Medline General Surgery Tray Kits: 1) ARTERIAL LINE INSERTION KIT
The catheter subassembly in the Integrated Arterial Catheter was manufactured with excess material on the catheter hub.
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Percussionaire Corporation medical device recall: VDR4 Phasitron Breathing Circuit Models that contain the venturi…
Due to internal venturi component getting transiently stuck in the forward position within the breathing circuit and may cause a reduction of amplitude and volume of…
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Nuwellis Inc medical device recall: nuwellis AquaFlexFlow UF 500 Plus
The AquaFlexFlow UF 500 Plus extracorporeal blood circuit used with the Aquadex SmartFlow and FlexFlow Systems may indicate "Ultrafiltrate Weight Mismatch" or Excessive…
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MEDLINE INDUSTRIES, LP - Northfield medical device recall: Medline Fluid Delivery Set with Drip Chamber: 1) FDS
Fluid Delivery Sets were incorrectly assembled with a white macro drip chamber instead of the required grey micro drip chamber. The macro drip chamber delivers three…
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Boston Scientific Corporation medical device recall: ACCOLADE DR Pacemaker
A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry…
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Mercury Enterprises, Inc. dba Mercury Medical medical device recall: Neo-Tee T-Piece Resuscitator
Gas powered emergency resuscitator has a circuit flow controller manufactured with an undersized spring, which may cause resuscitator not reach the high and low ends of…
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Olympus Corporation of the Americas medical device recall: Olympus MAJ-891 Forceps/Irrigation Plug
Potential for inadvertent retention of biomaterial when the reprocessing procedure is not performed as instructed, so as not completely removing and disassembling the…
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Baxter Healthcare Corporation medical device recall: Welch Allyn
There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.
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Abiomed, Inc. medical device recall: Impella RP with SmartAssist
Optical Sensors have been damaged due to physical interaction between the inlet and another device resulting in a Placement Signal Not Reliable (PSNR) alarm and loss of…
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Trokamed GmbH medical device recall: Sheath
If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fragments and kidney stone fragments, and quickly build up of…
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Maquet Cardiovascular, LLC medical device recall: VasoView HemoPro 2 Endoscopic Vessel Harvesting System. Model…
Potential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching from the Jaws of the Harvesting Tool
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Fresenius Kabi USA, LLC medical device recall: Ivenix Infusion System
Potential pneumatic valve failure that may cause the LVP to stop an active infusion and/or could prevent the pump from being used.
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Jiangsu Jumao X-care Medical Equipment Co Ltd medical device recall: JMC5A Ni/TruAire-5 Oxygen Concentrator
Oxygen concentrator may melt or catch on fire during use.
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Braemar Manufacturing, LLC medical device recall: Monitoring Service Application
Not all Electrocardiogram (ECG) events received July 2022-July 2024 were not properly routed and subsequently reviewed due to an analysis step being disabled with the…
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Nova Biomedical Corporation medical device recall: StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685.…
A software bug within the Gen 2 StatStrip Hospital Meter firmware leads to transmission of erroneous glucose patient test results to a healthcare institution's data…