Medical Product Outsourcing

Cardiovascular | Surgical

Boston Scientific Recalls, Discontinues LOTUS Edge Aortic Valve

Voluntary recall is related solely to the delivery system.

PR Newswire 11.17.20

R&D & Design

How Design Controls Can Prevent Medical Device Recalls

Incorporating risk management early in development will help eliminate problems before they impact the product’s manufacturing lifecycle.

Online Exclusives Ramya Sriram, Digital Content Manager, Kolabtree 11.16.20

BD Recalls Alaris Infusion Pumps Over Stuck, Unresponsive Keys

Could lead to an infusion delay or prevent clinicians from changing fluid or medication infusions.

U.S. Food and Drug Administration 09.15.20

Cardiovascular | Surgical

Endologix Recalls Ovation iX Stent Grafts Over Risk of Polymer Leaks

Issue caused by material weakness caused during the manufacturing process.

U.S. Food and Drug Administration 06.17.20

Neurological | Software & IT

Medtronic Recalls StealthStation Auto-Registration Feature Over Inaccuracies

Inaccuracies caused by minor patient movements during auto-registration; 11 injuries reported.

U.S. Food and Drug Administration 06.01.20

Cardiovascular

Medtronic Recalls HeartWare HVAD Pump Outflow Graft, Strain Relief

Outflow graft of the HVAD Pump may tear and the strain relief screw may break during assembly.

U.S. Food and Drug Administration 05.29.20

Cardiovascular | Surgical

Boston Scientific Recalls Imager II Angiographic Catheters

Catheter tip may detach during a procedure or preparation; nine reported injuries.

U.S. Food and Drug Administration 04.07.20

Software & IT

Building a Medtech Firm on a Foundation of Quality

C2DX impresses auditors and breezes through an MDSAP audit after implementing a medical device QMS.

Online Exclusives Nick Tippmann, VP of Marketing, Greenlight Guru 04.06.20

R&D & Design

Examining the Usability of Medical Software

Developers need to consider the ‘human factor’ when it comes to testing medical device software.

Bruce Johnston, Senior Software Engineering Specialist, MedAcuity Software 04.01.20

Medtronic Recalls Brain Aneurysm Stents

Delivery system may fracture during stent placement; one death reported.

U.S. Food and Drug Administration 03.30.20

BD Recalls Alaris System Infusion Pumps

Multiple system errors, software errors, and use-related errors have occurred; one death reported.

U.S. Food and Drug Administration 03.06.20

Testing

The Importance of Usability/Human Factors Testing

When is the work of human factors over, and how does your team know they are prepared for summative testing?

Maria Shepherd, President and Founder, Medi-Vantage 03.04.20

Software & IT

Expanding Quality Beyond the Four Walls of Your Organization

As suppliers can impact product quality, device manufacturers must oversee them as though they were an extension of the company and not an outside entity.

Seth Goldenberg, Ph.D., and Carl Ning, Veeva Systems 03.04.20

ResMed Recalls Stellar Ventilators

The sound alarm may fail to work for several reasons; there has been one reported death.

U.S. Food and Drug Administration 02.20.20

Cardiovascular

Abbott Recalls Coronary Dilatation Catheters

Balloons from the impacted lots may not deflate as intended; one death has been reported.

U.S. Food and Drug Administration 02.19.20

Teleflex Recalls COMFORT FLO Humidification System

Potential for water to flood the column and enter the circuit could cause fluid aspiration.

GlobeNewswire 02.18.20

Software & IT

The True Cost of Paper

Rethinking your approach to quality management.

Online Exclusives Jon Speer, Founder and VP of QA/RA at Greenlight Guru 02.13.20

Chronic Disease

Medtronic Recalls MiniMed Insulin Pumps

Incorrect insulin dosing has so far resulted in 2,175 injuries and 1 death.

U.S. Food and Drug Administration 02.12.20

GE Healthcare Recalls Carestation 600 Series Anesthesia Systems

Loose cable connection in the system may cause mechanical ventilation to stop working.

U.S. Food and Drug Administration 02.07.20

GE Healthcare Recalls CARESCAPE Respiratory Modules

A manufacturing issue may cause the devices to display incorrect oxygen values.

U.S. Food and Drug Administration 02.04.20

GE Healthcare Recalls Giraffe Incubators and OmniBeds

The bedside panels can be upright and look closed but not be securely latched, causing the potential for infants to fall.

U.S. Food and Drug Administration 12.18.19

Surgical

Cook Medical Recalls CrossCath Support Catheters

A manufacturing error may cause the marker bands to dislodge or cause buckling.

U.S. Food and Drug Administration 12.17.19

Medtronic Recalls SynchroMed II Infusion Pump

Foreign particles may be present inside the pump motor assembly, which may lead to a pump motor stall.

U.S. Food and Drug Administration 12.17.19

Diagnostics | Patient Monitoring

Can 'Smart Toilets' Be the Next Health Data Wellspring?

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Morgridge Institute for Research 11.14.19

Cardiovascular

Abbott Recalls CentriMag Circulatory Support System Motor

A calibration system error may cause the pump to slow or stop, the console screen to blank, and/or various inaccurate alarms.

U.S. Food and Drug Administration 11.05.19

Surgical

J&J's Ethicon Recalls ECHELON FLEX ENDOPATH Staplers

The staplers are being recalled for failure to completely form staples.

U.S. Food and Drug Administration 10.31.19

Cardiovascular | Surgical

Medtronic Recalls Catheters Due to Separation and Fragmentation Issue

Medtronic is recalling the 6 French Sherpa NX Active Guide Catheter due to a risk of the outer material separating from the device.

U.S. Food and Drug Administration 10.08.19

MPO Summit 2019 Conference Program Notebook

An ongoing update of MPO Summit 2019 sessions.

Online Exclusives Michael Barbella, Managing Editor 10.03.19

New Mobile App Notifies Patients, Caregivers and Nurses of Medical Device Recalls

SoomSafety aims to close the information gap between the FDA, manufacturers, and medical device users.

PR Newswire 09.06.19

Cardiovascular | Surgical

Edwards Recalls SAPIEN 3 Ultra Delivery System

Devices recalled due to burst balloons during surgery, which may result in vascular injury, bleeding, or surgical intervention.

U.S. Food and Drug Administration 08.22.19

Medline Recalls Primary Warmer Pack

Recalled because it contains the Vyaire Medical enFlow Fluid Warming Disposable Cartridge; there is a risk of exposure to elevated aluminum levels.

U.S. Food and Drug Administration 08.22.19

Software & IT

Fresenius Recalls Volumat MC Agilia Infusion Pump and Vigilant Agilia Drug Library

Devices were recalled due to a 'Low Priority' 'Keep Vein Open (KVO), End of Infusion' alarm and multiple software errors.

U.S. Food and Drug Administration 08.13.19

Diagnostics

QIAGEN Recalls Filter Tips Used with QIAsymphony SP/AS Instruments

The filter tips were recalled because of their potential to leak, which may result in delayed or inaccurate results.

U.S. Food and Drug Administration 08.06.19

Cardiovascular

Abbott Recalls Ellipse ICDs

The ICDs were recalled due to exposed aluminum wires that may prevent defibrillation therapy.

U.S. Food and Drug Administration 08.05.19

Surgical

Centurion Recalls Airway Kit Containing Sheridan Endotracheal Tubes

The kits were recalled due to the potential for the tube connector to dislodge, which may result in disconnection of the patient from the breathing circuit.

U.S. Food and Drug Administration 08.05.19

28. Varian

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07.30.19

Allergan Recalls BIOCELL Textured Breast Implants and Tissue Expanders

The global action follows the notification of updated safety information from the FDA.

PR Newswire 07.24.19

BD Offers Update on Infusion Pump Recall

Both pump products were formerly marketed under the CareFusion brand.

PR Newswire 07.18.19

Digital Health | Software & IT

Mobile App Notifies Patients, Caregivers, and Nurses of Medical Device Recalls

SoomSafety is the first mobile app to close the information gap between the U.S. FDA, manufacturers, and medical device users.

PR Newswire 07.15.19

GE Healthcare Recalls Giraffe and Panda i-Res Infant Warmers

The bedside panels and latch areas on the beds may crack, break, or become damaged if the unit is not properly used.

GE Healthcare 07.11.19

BD Recalls SmartSite Syringe Administration Set Due to Risk of Leaks

Leaks could result in under-infusion, delay or interruption, and/or contamination.

U.S. Food and Drug Administration 07.02.19

Edwards Recalls Intra-Aortic Occlusion Device Over Balloon Rupture Risk

The IntraClude balloon bursting may cause serious adverse health consequences related to increased time the patient is on cardiopulmonary bypass.

U.S. Food and Drug Administration 07.02.19

Software & IT

Fresenius Recalls Infusion Pump & Software Over Anomalies, End of Infusion Alarm

The recall is designed to solve four software anomalies that have the potential to cause over- or under-infusion of fluids or medications.

Business Wire 07.01.19

Surgical

Teleflex Recalls Endotracheal Tubes Over Risk of Connector Disconnecting from Breathing Circuit

Teleflex Medical has received 179 complaints with 192 occurrences in association with the ETT disconnection.

U.S. Food and Drug Administration 06.21.19

Cardiovascular | Surgical

Cook Recalls PTA Balloon Catheters Due to Balloons Bursting

Multiple complaints were received for balloons in Cook's Advance Enforcer 35 Focal Force PTA Balloon Catheter bursting below the rated burst pressure.

U.S. Food and Drug Administration 06.19.19

Software & IT