Regulatory Affairs Syndicator

A failure on the power supply assembly can result in either "No DC power" or "No DC or AC power". A failure of DC (battery) power can result in the inability to deliver defibrillation therapy if the device will not turn on using DC (battery) power and…

Reason for Recall: If the AED is used with an affected battery pack, the AED may falsely detect an error condition, cancel charge and not provide therapy.

The Elecsys® Anti-HCV Immunoassay is a laboratory test used to detect antibodies associated with the hepatitis C virus (HCV) infection. Antibodies are proteins produced by the body to fight against foreign substances, such as viruses and bacteria.

The Complete SE Vascular Stent is a thin, flexible metal mesh tube that can be implanted in the large arteries that supply blood to the pelvis and legs (iliac arteries). It consists of two parts, the stent and the delivery system. The stent is an…

Reason for Recall: The sheath tip may break off and separate while the sheath is inside a blood vessel. If this occurs, the sheath tip could move through the blood vessel into organs such as the lungs and heart or, less commonly, into arteries.

The Medtronic Melody® Transcatheter Pulmonary Valve is a manufactured replacement pulmonary heart valve that had already been previously repaired. The pulmonary valve is one of four valves in the human heart that help pump blood throughout the body.

The CONSERVE® Plus Total Resurfacing Hip System is a metal on metal resurfacing artificial hip replacement system, surgically implanted to replace a hip joint. The CONSERVE® Plus Total Resurfacing Hip System is called a resurfacing prosthesis because…

Reason for Recall: The current labeling for Medtronic Sutureless Connector (SC) catheters and revision kits (known collectively as SC catheters) incorrectly states that SC catheters are intended to be used with Medtronic IsoMed constant-flow infusion…

Reason for Recall: Some of the products were manufactured with internal diameters smaller than indicated on the labeling. The clinician may have difficulty passing through or withdrawing the suction catheter.

Reason for Recall: An extremely humid environment may cause the LIFEPAK CR Plus AED to improperly analyze the rhythm correctly and may cause the device to delay or fail to delivery therapy.

Reason for Recall: The device has a switch problem where it may self-activate without pushing the trigger, continues running after releasing the trigger, and runs in unintended directions.

Reason for Recall: The cable may cause the electric handpiece to self-activate.

Reason for Recall: This device may increase the resistance of the flow of air into the lungs, resulting in ineffective ventilation and the inability to verify the correct placement of a breathing tube when inserting it into the windpipe.

Due to a manufacturing error, the catheters may contain pin holes and exposed wire braids which may result in a brain clot or a blood vessel puncture, and this may lead to possible death.

Reason for Recall: These out-of-date devices may cause serious injury to infants or caregivers.