All Recalls

There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.

Devices which did not undergo thermoforming could deform and lose performance.

There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.

There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.

Devices which did not undergo thermoforming could deform and lose performance.

There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.

To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.

942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay to exchange devices or revision surgery.

Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.

Devices which did not undergo thermoforming could deform and lose performance.

To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.

Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.

A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.

Devices which did not undergo thermoforming could deform and lose performance.

Devices which did not undergo thermoforming could deform and lose performance.

There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.

A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.

Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result).

Devices which did not undergo thermoforming could deform and lose performance.

Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result).