Alerts/Adverse Events

In short We don’t know whether the FDA has its pen hovering over the tick box for MitraClip or not, … continue reading “Abbott’s MitraClip Suffers Untimely Setback”

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.

The FDA has issued a Class I recall, it’s highest category, for the HeartSine Samaritan 300/300P Public Access Defibrillator which seems to be suffering battery depletion and software issues which may prevent it being able to dispense its therapeutic dose.

Registry data collected from patients undergoing treatment with Wingspan under US Humanitarian device exemption approval has resulted in FDA issuing more limited indications for use. Yet in Europe we seem to be burying our heads in the sand on the device’s shortcomings.

A fine example of how problems can befall a medical product. In this case, overzealous zapping (alright, gamma irradiating) one particular lot of an X-Ray detectable swab during manufacture has had the potential effect of causing its X-Ray detectable thread to fall to pieces.

UK regulatory agency the MHRA has issued a device alert relating to the MicroPace 4580 from Pace Medical, distributed in the UK by APC Cardiovascular. Full details of the alert and required actions can be found here.

Certain of Covidien’s Shiley, reusable cannula, cuffed trachoestomy tubes appear to have leakage and disconnection issues, which has lead to the UK’s MHRA issuing a Medical Device Alert.

UK regulatory authority the MHRA is very keen to ensure that all pertinent information on the management of the potential for externalised ICD leads, reaches the appropriate medical professional, so has issued a follow up device alert with updated guidance.

One specific LOT of Baxter’s sterile water for irrigation may be contaminated by a bacterium. As a precautionary measure the company is acting and UK’s regulatory body has issued a device alert calling for quarantining of identified product as further investigation is performed.

Are the summer doldrums a good time to bury bad news or an opportunity to get your story to the top of the editor’s “hmmm interesting” list? We ponder this and other matters in our weekly View From The Med.

FDA has issued updated guidance on the clinical management of problematic Riata and Riata ST ICD leads. We take a considered look at how patients must be feeling and how well they’re getting looked after through this whole stressful experience.

As is often the case a company’s voluntary recall has morphed into the FDA Class 1 variety. This time it’s Covidien’s Shiley Adult Tracheostomy Tubes which have reportedly suffered disconnection and leakage.

UNomedical’s neria infusion sets are the subject of a Medical Device Alert in UK as a result of the identified risk of needle breakage with the consequent need for needle removal.

A “Talking” Blood Glucose Meter that doesn’t talk. A sterile urinary catheter that isn’t sterile. A reprocessing unit that risks contaminating its contents. A week in the life of UK MHRA’s safety/recalls/alerts department.

While the toxicology work continues, it seems implant data is still saying the same thing, that PIP implants rupture more frequently than other implants, that in most cases there is no reaction, and when there is a reaction it’s obvious. Most significantly data confirms no resultant cancer.

UK’s regulatory authority the MHRA has issued a Medical Device Alert(MDA) pertaining to all lot numbers and product codes of the EMS ET Tube Clamp/Holder because of a risk of airway loss due to slippage of the clamp/holder or airway obstruction as a result of over-tightening of the clamp/holder.