Covidien’s quietly recalling its Roticulators for packaging concerns, but seems to be doing so by stealth rather than adopting the slightly more communicative route one might expect to see.
Recalls
ExpertRECALL™ Index Shows Medical Device Recalls Soar During First Quarter
An interesting read for anyone involved in medical devices. It’s perhaps unsurprising to see the data which after all only supports what we’ve seen… a series of high profile problems resulting in more than twice the number of recalls during Q1 than in the previous period.
Now FDA Issues Class I “Recall” For Thoratec Ventricular Assist Device
FDA draws attention to potential problems with Thoratec’s HeartMate II LVAS pump.
St Jude’s Brio™ Deep Brain Stimulation System Withdrawn For Fix
St Jude has recalled and suspended sales of its Brio Deep Brain Stimulation system until it resolves the issue of body fluid ingress, which it believes is causing a lack of therapeutic effect.
FDA Recall: Acclarent Inspira AIR™ Balloon Dilation System, Size 18X40mm
Acclarent’s voluntary recall of its Inspira Air™ balloon dilatation system has been formalised as a FDA Class 1 recall.
Cardiac Science Recalls Certain Automated External Defibrillators
Diligent QC inspections have identified a potential problem with some of Cardiac Science’s AEDs, prompting a recall.
Metal-on-Metal: Should FDA Concerns Have Made DePuy Act Sooner Overseas?
A new article in the New York times suggests J&J DePuy were wrong in continuing to sell product overseas after FDA raised concerns. If that happened every time FDA demanded more clinicals we might as well harmonise.
New Research Suggests Sprint Fidelis Guidance Should Be Reviewed
Higher failure rates identified by researchers may indicate a policy of replacing Sprint Fidelis ICD units that haven’t malfunctioned.
Now UK NHS Issues Its Own Statement On All Metal Hips.
Following another media flare-up in the ongoing metal-on-metal discussion, NHS has followed UK competent authority the MHRA into releasing a positioning document of its own.
Sparks Fly At Riata Lead Summit
A sizeable group of clinicians and St Jude representatives have met to discuss the issue of “externalised” Riata implantable defibrillator leads.
Medical Device Alert: Smiths Medical Bivona® Neonatal, Pediatric and Flextend Tracheostomy Tubes
UK MHRA has issued a Medical Device Alert relating to Bivona® Neonatal, Pediatric and Flextend Tracheostomy Tubes manufactured by Smiths Medical.
Covidien Updates Voluntary Recall of BIS™ Bilateral Sensors.
Covidien has reinforced implementation of its voluntary recall of BIS bilateral Sensors, undertaken last November, with a reminder in the form of an update, that use of affected iterations of the product could result in what the company refers to as inaccurate calucation and presentation of key data.
Covidien Contraindicates Use of Duet TRS™ For Thoracic Surgery And Implements Voluntary Recall.
Covidien has today announced that it is conducting a voluntary recall of all production lots for the Duet TRS™ Universal Straight and Articulating Single Use Loading Units, with respect to the use of this product family in the thoracic cavity.
Medical Device Alert: Molnlycke Health Care ProcedurePaks®
UK MHRA has issued a Medical Device Alert relating to Molnlycke Health Care ProcedurePaks® with devices containing latex, which have been labelled as latex-free.
Hospital Defibrillators: AHA Admits Old Models Outperform New
When the rush to new technology may need more consideration: How the American Heart Association may have to resuscitate its policy on defibrillators.
Medtronic’s pain pump recall won’t hurt the bottom line, analysts say
Analysts don’t expect Medtronic’s second Class I recall for its SynchroMed II implantable painkiller pump to put much of a dent in the overall business.