Abbott

Software malfunction may occur during pacing capture threshold test of pacemaker resulting in programmer not successfully communicating the command to terminate the test.

It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product Instructions for Use.

Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results

Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results

Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results

Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results

Abbott Laboratories is recalling their Alinity ci-series System Control Module, a chemistry/immunoassay anayzer, by correction. The reason for the recall is potential performance issues found in the Alinity ci-series System software versions 3.6.1. and lower that could lead to erroneous results for multiple analytes. The issue was identified by Abbott during the internal testing of complaint investigations.

Software issue for hq analyzer results in system not visibly applying appropriate flagging to results when saturation is present which may result in incorrect results.

There is a potential issue affecting Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Generators (IPGs), Model 32400 and Liberta RC Deep Brain Stimulation (DBS) Implantable Pulse Generators (IPGs), Model 62400 . These devicess may experience a loss of communication with the Clinician Programmer (CP) and/or the Patient Controller (PC).

There is a potential issue affecting Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Generators (IPGs), Model 32400 and Liberta RC Deep Brain Stimulation (DBS) Implantable Pulse Generators (IPGs), Model 62400 . These devicess may experience a loss of communication with the Clinician Programmer (CP) and/or the Patient Controller (PC).

Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.

Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.

Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.

Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.

Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.

Device may have a small breach in the proximal end of the shaft under the strain relief of the delivery system. Breach is not visibly detectable and may lead to prolonged procedure, blood loss, or air ingress with potential for air embolism.

Device may have a small breach in the proximal end of the shaft under the strain relief of the delivery system. Breach is not visibly detectable and may lead to prolonged procedure, blood loss, or air ingress with potential for air embolism.

Certain NT2000iX RF generators were serviced using a tool that was subsequently found to be out of tolerance and therefore may not have provided accurate results for potential capacitance failure.

There is an overall reported incidence rate of 0.77% related to observed or potential air embolism during procedures in which the ASDS product was used.