FDA Issues Mammography Notice
When mammography facilities are found to be noncompliant with quality standards, the FDA can require the facility to perform a patient and provider notification.
The facility will receive a letter citing the reasons for the PPN action and instructions to complete to become compliant, the FDA said in a notice issued July 27.
The facility is assigned a compliance officer to guide it through the actions it needs to take to become compliant. The agency will then track the notification procedures and audit the facility. Read the notice here: .
Carefusion Recalls Laparoscopes, Ventilators
Carefusion issued an urgent recall of several of its laparoscopes, including the DiamondFlex circular retractor and the SnowdenPencer.
The Class I recall was issued because BD, formerly Carefusion, identified a weld failure that could result in the wire protruding through the tip of the instrument, which could damage tissues or organs. Customers were instructed to return the affected devices.
The same week, the company turned around to issue anotherfor its AVEA ventilators due to an electrical issue that could cause the device to shut down unexpectedly.
The AVEA recall affects 501 units distributed in the U.S.
Reports of Catheter Breakage Triggers Recall
Stryker Sustainability Solutions announced that it was recalling 167 Soft-Vu Omni Flush Angiographic catheters following reports of the product top breaking off during usage.
The recall, which the FDA designated a Class I recall, affects products distributed in 11 states between January 2004 and December 2008.
Tip separation can lead to internal organ injury and multiple other serious adverse events.
SPR Therapeutics’ PNS Cleared
SPR Therapeutics has received clearance from the FDA to market the Sprint Peripheral Nerve Stimulation (PNS) system.
This pain management device allows lead placement as far as two to three centimeters from the intended nerve.
The PNS is fully reversible, as the device is designed to be removed without surgery at the end of the 30-day treatment period.
Itamar’s C-PAP Gains Indication
Itamar Medical received FDA clearance to expand the indication of their sleep apnea diagnostic device to include younger patients.
The tool is now approved for use in patients as young as 12. It previously had been approved only for use in patients 17 and older.
Similar approvals already have been granted in Europe and Japan.
Canada Approves Edwards’ Heart Valves
Health Canada has approved Edwards Lifesciences’ heart valve Edwards Sapian 3 for use.
The product is approved for use in patients who suffer from symptomatic aortic stenosis and are at high risk for surgical replacement.
Edwards’ new valve is available in four sizes: 20 mm, 23 mm, 26 mm and 29 mm.