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Search Results for '
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Cardiovascular
J&J's Abiomed Recalls Impella Left-Sided Heart Pumps for Perforation Risk
The pump catheter may perforate the wall of the heart’s left ventricle.
Sam Brusco, Associate Editor
03.21.24
Philips Recalls Panorama 1.0T MRIs Over Risk of Explosion
Philips said this was the first explosion event in 22 years of use.
Sam Brusco, Associate Editor
12.21.23
Surgical
Medtronic Recalls StealthStation Due to Software Glitch
The glitch can cause surgical plan data to shift location(s) after the initial test is changed.
Sam Brusco, Associate Editor
12.20.23
Medical Device Manufacturing Recalls—Mike on Medtech
Mike Drues and Sean Fenske discuss the reasons for the increase in recalls for manufacturing issues and how to avoid them.
Sean Fenske, Editor-in-Chief
10.03.23
Cardiovascular
Getinge Recalls Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps
The company recalled the IABPs over unexpected shutdown due to electrical failures in their power management or solenoid boards.
Sam Brusco, Associate Editor
08.10.23
GE HealthCare Recalls TruSignal SpO2 Sensors
The sensors may reduce the amount of energy sent to the heart during defibrillation without transmitting an alert
Sam Brusco, Associate Editor
07.31.23
Cardiovascular
Abbott Recalls Amplatzer Steerable Delivery Sheath for Air Embolism Risk
Air embolism can cause injuries like acute reduction in blood flow to the heart.
Sam Brusco, Associate Editor
07.28.23
Cardiovascular
Medtronic Recalls ICDs, CRT-Ds Over Energy Output Issue
Devices made after 2017 with a glass feedthrough might deliver low or no energy output when high-voltage therapy is needed.
Sam Brusco, Associate Editor
07.18.23
Surgical
J&J's Ethicon Recalls Megadyne Electrodes Over Burn Risk to Patients
A J&J MedTech spokesperson reached out to MPO with an update on the recall.
Sam Brusco, Associate Editor
07.12.23
Teleflex Recalls Certain Rüsch Endotracheal Tubes
Teleflex received 189 reports of disconnection of the 15 mm connector from the endotracheal tube.
Sam Brusco, Associate Editor
06.22.23
Philips Recalls Certain Reworked DreamStation CPAP, BiPAP Machines
There's a risk they may deliver inaccurate or insufficient therapy.
Sam Brusco, Associate Editor
04.11.23
Chronic Disease
|
Patient Monitoring
Abbott Recalls Some FreeStyle Libre Readers Over Battery Issues
Batteries may get very hot, spark, or catch fire if not correctly stored, charged, or used with Abbott-provided USB cable and power adapter.
Sam Brusco, Associate Editor
04.11.23
Chronic Disease
Insulet Recalls Omnipod DASH Personal Diabetes Managers
Medical Device Correction issued over battery issues.
Sam Brusco, Associate Editor
11.07.22
Teleflex Recalls Iso-Gard Filter S for Risk of Splitting, Detaching
May cause leakage and insufficient air supply to patients.
Sam Brusco, Associate Editor
11.01.22
Neurological
|
Patient Monitoring
Integra Recalls CereLink ICP Monitor
There have been reports of incorrect intracranial pressure readings.
Sam Brusco, Associate Editor
09.01.22
Hamilton Medical Recalls Hamilton-C6 Intensive Care Ventilator
Potential water ingress may cause breathing support to stop.
Sam Brusco, Associate Editor
08.30.22
Philips Recalls Certain BiPAPs Due to Plastic Issue
Recall isn’t associated with the PE-PUR foam issue that was brought to light last year.
Sam Brusco, Associate Editor
08.30.22
BD Recalls Intraosseous Products Over Multiple Issues
The recall has been identified as Class 1.
Sam Brusco, Associate Editor
08.11.22
BD Recalls Certain Intraosseous Products
Affected lots include needle set kits, manual driver kits, and powered drivers.
Sam Brusco, Associate Editor
06.23.22
Draeger Recalls SafeStar 55 Breathing System Filters for Potential Obstructions
The defective filters may block oxygen flow to patients.
Sam Brusco, Associate Editor
06.21.22
Avanos Recalls Cortrak*2 Over Potential Enteral Tube Misplacement
There have been 60 injuries and 23 deaths related to this issue.
Sam Brusco, Associate Editor
05.16.22
Cardiovascular
|
Surgical
Medtronic Recalls Harmony TPV Delivery Catheter
Bond holding the capsule at the end of the catheter may break during a procedure.
Sam Brusco, Associate Editor
04.26.22
Philips Recalls V60 Ventilator Product Family
Affected units may cease to operate, potentially without setting off an audible/visual alarm.
Sam Brusco, Associate Editor
04.25.22
Cardiovascular
CSI Recalls WIRION Embolic Protection System
Company received complaints about filter breakage during retrieval.
Sam Brusco, Associate Editor
01.10.22
Medtronic Recalls Puritan Bennett 980 Series Ventilator
Manufacturing assembly error may cause loss of ventilation; 1 death reported.
Sam Brusco, Associate Editor
01.03.22
Surgical
Teleflex Recalls Arrow-Trerotola Over-the-Wire PTD Kit
PTD’s Inner lumen (orange) may detach from the device’s basket.
GlobeNewswire
11.29.21
Cardiovascular
|
Surgical
CSI Recalls WIRION Embolic Protection System
Complaints about filters breaking during retrieval.
Sam Brusco, Associate Editor
11.29.21
Diagnostics
Ellume Recalls COVID-19 Home Test for Potential False Positives
Higher-than-acceptable false positive test results for SARS-CoV-2.
U.S. Food and Drug Administration
11.10.21
Cardiovascular
|
Surgical
Getinge Recalls Cardiosave Hybrid/Rescue Intra-Aortic Balloon Pump Battery Packs
Recalled due to risk of battery failure.
U.S. Food and Drug Administration
11.02.21
Cardiovascular
|
Surgical
Cook Medical Recalls Transseptal Needles
Were found to have rust internally, externally, or both.
Business Wire
10.19.21
Diagnostics
Abbott Recalls Alinity COVID-19 Tests Due to False Positive Risk
False positives may be related to current mixing parameters for the chemicals combined with patient samples.
U.S. Food and Drug Administration
10.14.21
Chronic Disease
UPDATE: Medtronic to Replace Recalled MiniMed Insulin Pumps
The company will replace any MiniMed 600 series insulin pump with the recalled retainer ring.
U.S. Food and Drug Administration
10.06.21
Cardiovascular
Boston Scientific Recalls INGENIO Pacemakers, CRT-Ps
Devices recalled due to risk of transition to safety mode.
U.S. Food and Drug Administration
08.12.21
Philips Recalls CPAP, BiPAP Over Debris and Chemical Exposure Risk
Polyester-based polyurethane (PE-PUR) sound abatement foam may break down.
U.S. Food and Drug Administration
07.26.21
Philips Recalls Certain Sleep and Respiratory Care Devices
Mitigates potential health risks related to the sound abatement foam component.
GlobeNewswire
06.14.21
Cardiovascular
Abbott Recalls Assurity, Endurity Pacemakers
Potential moisture ingress is causing electrical shorts and reduced battery life.
Sam Brusco, Associate Editor
05.17.21
Cardiovascular
Medtronic Recalls Unused Valiant Navion Thoracic Stent Graft Systems
Informs physicians to cease use of the device until further notice.
Charles Sternberg, Assistant Editor
02.17.21
Surgical
Penumbra Recalls JET 7 Reperfusion Catheter Over Distal Tip Damage
14 patient deaths have been reported.
Sam Brusco, Associate Editor
01.29.21
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
Breaking News
Getinge Donates Extensive Medical Equipment to Ukraine
Olympus Names Julien Sauvagnargues CEO of the Americas
Mark Pugh Assumes CEO Role at Theragenics
Art Taylor Named to Endologix Board of Directors
Michael Bourque Named Chief Financial Officer at Inogen
View Breaking News >
CURRENT ISSUE
March 2024
Evaluations for the EU: The Impact on Testing & Lab Services
A Matter of Fact for Medical Device Materials
The Sweet Science of Diabetes Technology
View More >