All Articles in: Alerts/Adverse Events

Thoratec Says Switches from Older HeartMate EPC System Controller to Pocket Controller Highest RiskMarch 18, 2014

Thoratec has issued updated information regarding the problems highlighted in its device correction letter of two weeks ago. It’s reinforcing the guidance that patients should visit their doctor for retraining on how to use the Heartmate II device in the light of new evidence that the process of changing from older controllers presents the highest risk of problems.

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Vascutek Stent Graft Back in CirculationMarch 13, 2014

Scottish vascular graft company Vascutek has announced the return to market of its Anaconda™ Bifurcate Body Stent Graft System. The system has been out of circulation since October 2013.

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Deaths Prompt Thoratec to Issue Warning on HeartMate II® LVASMarch 5, 2014

Heart assist device company Thoratec Corporation has initiated a voluntary worldwide Medical Device Correction in order to update its labeling and training materials for the HeartMate II® LVAS Pocket System Controller. The advisory follows four deaths among patients while initiating switches of controller.

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Mathys Issues Urgent Field Safety Notice for balanSys® Knee SystemFebruary 5, 2014

With total joint implants, one tiny mistake can have significant consequences. In this case no patient injury has been reported, but labelling within the Mathys balanSys Knee system incorrectly matches tibial and femoral components, with the risk of subsequent instability and pain. The company has issued a field safety notice.

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Device Alert for Upside Down Vena Cava FilterJanuary 3, 2014

The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has issued a device alert relating to certain lots of OPTEASE® retrievable vena cava filter, manufactured by J&J’s Cordis Corporation.

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Internal Fault Prompts FDA Safety Communication on Philips’ HeartStart Auto DefibrillatorsDecember 5, 2013

Certain HeartStart automated external defibrillator (AED) devices made by Philips Medical Systems, a division of Philips Healthcare, may be unable to deliver needed defibrillator shock in a cardiac emergency situation, the US FDA has said in a new safety communication for users of these previously recalled devices.

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Serious Tissue Erosion Warning for St.Jude Amplatzer Atrial Septal OccluderOctober 18, 2013

The FDA has issued an alert to health care providers and patients concerning its Amplatzer Atrial Septal Occluder (ASO). It seems that in very rare instances, tissue surrounding the device can erode, resulting in life-threatening emergencies that require immediate surgery.

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Risk of Embolus from Edwards’ Embolus Filter Provokes UK RecallOctober 8, 2013

A customer complaint investigation uncovered a potential problem with Edwards Lifesciences’ EMBOL-X Glide Protection System. It seems incidences of a bent tip may present a risk of breakage and subsequent embolization, so in the UK at least the company has issued a recall notice for certain batches.

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MHRA Device Alert: CareFusion Infusion PumpsAugust 13, 2013

The UK’s regulatory overlord, the MHRA has issued a device alert pertaining to CareFusion’s Alaris® GP, GP Guardrails®, GP Plus and GP Plus Guardrails Infusion pumps, product codes 80263UN01, 80263UN01-G, 9002MED01, 9002MED01-G

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Device Alert: Medtronic SynchroMed II and SynchroMed EL Implantable Drug PumpsJune 26, 2013

Medtronic has recently issued four Field Safety Notices (FSN) related to the SynchroMed II and SynchroMed EL implantable drug pumps and accessories. These have been wrapped up into one Device Alert by the UK’s MHRA regulatory authority.

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UK Plastic Surgeons Jump On Swedish PIP ResultsJune 11, 2013

When Sweden’s device authority called for all PIPs to be removed last week their evidence was seized upon by UK plastic surgeons in the form of their specialty body, the British Association for Aesthetic Plastic Surgeons (BAAPS) which is now …

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Swedish Regulators Want All PIPs OutJune 5, 2013

According to a release from the UK’s MHRA, its Swedish equivalent has adopted the position that PI implants should be removed as a precautionary measure. The MHRA has issued its own statement reasserting its position that this is not necessary in all cases.

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Medical Device Alert: Unomedical Reinforced ET Tubes Potential To Delaminate And Restrict AirflowMay 30, 2013

The UK’s regulatory agency, the MHRA has issued a device alert relating to reinforced endotracheal (ET) tubes manufactured by Convatec company Unomedical The device types are Murphy, Magill, Murphy with stylet and Magill with stylet.

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FDA Warns That Stolen Covidien Stapler Reloads Not SterileMay 8, 2013

The FDA has issued a warning to healthcare professionals that stolen Covidien stapler reloads may be in circulation. The reloads are labelled sterile, but were stolen from the company prior to sterilisation taking place.

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Abbott’s MitraClip Suffers Untimely SetbackMarch 26, 2013

In short We don’t know whether the FDA has its pen hovering over the tick box for MitraClip or not, but the advice of its circulatory devices panel was to approve the thing. We also don’t know whether a warning …

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FDA Class I Recall For Lumenis VersaCut Tissue MorcellatorFebruary 26, 2013

Israeli device company Lumenis Limited is recalling certain models of VersaCut Morcellator devices because of the potential for air embolisms to occur if the aspiration tubing is hooked up backwards to the aspiration control box housing.

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