Edwards Lifesciences (NYSE:EW) issued a recall of certain lots of Perimount replacement heart valves over concerns that they may have been contaminated with "extremely small" metallic particles during packaging.
"If particles enter the body, there is a risk that the particles can migrate," but patients already implanted with the affected devices are unlikely to experience problems, according to the urgent field safety notice.
Based on the likely number of particles in any affected Perimount jar, the likelihood of the particles washing off during the prescribed valve rinse procedure and the tininess of the particles themselves, the company believes that "injury to patients implanted with an affected device is unlikely," according to a letter. The packaging issue was discovered during regular internal reviews.
The affected valves were distributed in Europe, Asia, Canada, Africa, Latin America, Australia and Japan, Edwards Lifesciences spokeswoman Janet Kim told MassDevice.com today. The recall does not affect any products sold in the U.S.
Nonetheless, Edwards opted to recall all unused Perimount devices from the specified lots, which amounts to about 1,000 heart valves and 50 transcatheter heart valves, Kim added.
Natus Medical launches field action on Olympic Cool-Cap infant cooling systems
Natus Medical announced a pair of field actions relating to its Olympic Cool-Cap infant cooling devices.
Affecting all Cool-Cap customers, the company noted a few rare instances in which the device’s control module screen froze, continuing to display active information but no longer supplying cooling to the infant.
In a second action, Natus plans to replace the power supply on a limited lot of Cool-Cap systems after receiving reports of power failure.
Read more
Capatex recalls neonatal endotracheal tubes
Capatex Medical recalled older lots of certain neonatal endotracheal tube SCP clamp holders over concerns that a new plastic used in the devices may result in slippage or over-tightening, resulting in a potential airway loss.
Read more
