FDA: Recall of Isomeric sterile compounded products
Editor's Note The Food and Drug Administration (FDA) on April 6 announced the recall of all lots of sterile products compounded and packaged by Isomeric Pharmacy Solutions (Salt Lake City, Utah). The recall was issued because of FDA concerns of a lack of sterility assurance, which were brought to Isomeric’s…
FDA: Recall of Medtronic’s StrataMR adjustable valves and shunts
Editor's Note The Food and Drug Administration (FDA) on April 8 announced the recall of all StrataMR adjustable valves and shunts manufactured by Medtronic (Dublin, Ireland). The recall was issued because of a postimplantation problem that can lead to under-drainage of cerebrospinal fluid, which can lead to headaches, nausea, vomiting,…
FDA: Class I recall of Merit Medical’s sheath introducer
Editor's Note The Food and Drug Administration (FDA) on March 31 labeled Merit Medical Systems' (South Jordan, Utah) recall of the Prelude Short Sheath Introducer as Class I, the most serious. The recall was issued because of a manufacturing defect that may cause the tip to separate from the sheath…
FDA: Field corrective action for Medtronic’s Newport HT70, HT70 Plus ventilators
Editor's Note On April 5, the Food and Drug Administration (FDA) announced that Medtronic (Minneapolis) has notified its customers of a field corrective action for all Newport HT70 and Newport HT70 Plus ventilators manufactured since 2010. The field corrective action is being conducted after reports that the ventilator may reset…
Olympus redesigned duodenoscope linked to new infection outbreak
Editor's Note A new outbreak of infections outside the US have been tied to a duodenoscope Olympus modified last year to reduce the risk of transmitting bacteria between patients, the March 22 Los Angeles Times reports. The outbreak of Klebsiella pneumoniae in five patients occurred at the end of December…
FDA: Class I recall of HeartStart MRx Monitoy/Defibrillator
Editor's Note The Food and Drug Administration (FDA) on March 24 identified the recall of the HeartStart MRx Monitor/Defibrillator by Phillips Healthcare (Amsterdam) as Class I, the most serious. The recall was initiated because of electrical and battery connection issues that may prevent the device from powering up, charging, and…
FDA updates data on breast implant-associated anaplastic large cell lymphoma
Editor's Note In a March 21 Safety Alert, the Food and Drug Administration (FDA) updated its data on breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) to reflect the World Health Organization designation of BIA-ALCL as a rare T-cell lymphoma that can develop following breast implants. At this time the data…
FDA Safety Alert on Absorb GT1 Bioresorbable Vascular Scaffold
Editor's Note The Food and Drug Administration (FDA) on March 18 issued a Safety Alert for Abbott Vascular’s (Santa Clara, California) Absorb GT1 Bioresorbable Vascular Scaffold (BVS). The alert was issued to inform healthcare providers of an increased rate of major adverse cardiac events in patients receiving the BVS, when…
FDA: Class I recall of Medtronic implantable drug infusion pumps
Editor's Note The Food and Drug Administration (FDA) on March 14 categorized the recall by Medtronic (Minneapolis) of its SynchroMed II and SynchroMed EL implantable drug infusion pumps as Class I, the most serious. The pumps are being recalled because a software problem may cause unintended delivery of drugs during…
FDA issues alert on use of angioplasty devices in TVAM
Editor's Note The Food and Drug Administration (FDA) on March 8 issued a Safety Alert about the use of balloon angioplasty devices to perform an experimental procedure, called transvascular autonomic modulation (TVAM). TVAM consists of threading a catheter into a patient’s venous system, such as the jugular vein, where a…
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