FDA: Class I recall of HeartWare HVAD system by Medtronic
Editor's Note The Food & Drug Administration on June 1 identified the recall by Medtronic of its HeartWare Ventricular Assist Device (HVAD) system as Class I, the most serious. The recall was initiated because of the possibility for an interruption to occur in the electrical connection between the system’s power…
FDA: Class I recall of HeartMate 3TM Left Ventricular Assist System
Editor's Note The Food and Drug Administration on May 22 identified the recall by Abbott of all lots of its HeartMate 3TM Left Ventricular Assist System as Class I, the most serious. The recall was issued because of a malfunction in the device’s outflow graft assembly that may cause the…
FDA: Class I recall of Medtronic’s MindFrame Capture LP revascularization device
Editor's Note The Food and Drug Administration (FDA) on May 18 identified the recall of Medtronic’s MindFrame Capture LP revascularization device as Class I, the most serious. Medtronic is recalling the device because there is a risk of the delivery wire breaking or separating during use. The clot retriever, which…
FDA: Class I recall of Vyaire Medical AirLife Resuscitation Device & Broselow Convenience Kit
Editor's Note The Food and Drug Administration (FDA) on May 11 announced the Class I recall, the most serious, of Vyaire Medical Inc's (Lake Forest, Illinois) AirLife Resuscitation Device & Broselow Convenience Kit. The recall was initiated because of an error in product design that may result in difficulty or…
FDA: AuroMedics Pharma recalls two lots of Piperacillin and Tazobactam for Injection
Editor's Note The Food and Drug Administration (FDA) on May 8 announced the recall by AuroMedics Pharma (Windsor, New Jersey) of two lots of Piperacillin and Tazobactam for Injection, USP 3.375 g in a single-dose vial. The vials were found to contain particulate matter after reconstitution that was confirmed to…
FDA: Class I recall of Fabius Anesthesia Machines by Dräger Medical
Editor's Note The Food and Drug Administration (FDA) on May 9 announced a Class I recall, the most serious, of Fabius Anesthesia Machines by Dräger Medical. The recall was initiated because of excessive oil that was not removed at the time of production. Excess oil may interfere with the position…
FDA sends letter to healthcare providers on neurovascular stents
Editor's Note The Food and Drug Administration (FDA) on May 8 sent a letter to healthcare providers that included recommendations on the use of neurovascular stents for stent-assisted coiling in the treatment of unruptured brain aneurysms. The FDA has received reports associated with these devices that suggest events of peri-procedural…
FDA: AuroMedics recalls two lots of Ampicillin and Sulbactam for Injection
Editor's Note The Food and Drug Administration (FDA) on May 8 announced the recall by AuroMedics Pharma (Windsor, New Jersey) of two lots of Ampicillin and Sulbactam for Injection USP, 3 g single-dose vials. The recall was issued because of customer complaints of the presence of red particulate matter in…
FDA approves firmware update for Abbott ICDs, CRT-Ds
Editor's Note The Food and Drug Administration (FDA) on April 17 announced that it had approved a firmware update that is now available for certain Abbott (formerly St Jude Medical) implantable cardiac devices (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). The update is a corrective action (recall) to reduce the…
FDA alert: Coastal Meds recalls all sterile products
Editor's Note The Food and Drug Administration (FDA) on April 13 announced the recall by Coastal Meds (Biloxi, Mississippi) of all nonexpired products marketed as sterile because of visible particles in some of the drug vials for injection and poor sterile production practices. The FDA on April 5 requested the…
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