Medical Device Recalls: FDA Device Safety Alerts And Recall Notices

There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.

All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.

Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments

Whole-Body MR scanners used to produce images of the inside of the human body to aid diagnosis of disease may have been manufactured/serviced with ferrous (steel) fittings instead of non-ferrous (brass) fittings on the magnet rear and if system is accessed to perform service while the magnet is ramped, the magnetic field could attract the ferrous fittings potentially resulting in personnel injury.

Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential consequences associated with detachment of fragments from valve include foreign body in patient's tracheobronchial tree, which may require intervention for removal. Other potential consequences include inflammatory response, hypoxia, and prolongation of procedure.

Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.

Elevated endotoxin levels identified in affected lots. Issue may elicit strong inflammatory response if used, including local tissue irritation, delayed wound healing, or systemic effects such as fever and hypotension. In severe cases, septic shock may result.

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.

Due to the likely presence of contamination in well(s).

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

Probes may rupture/burst during activation

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Product labeling includes a fetal indication for use that is not cleared under its 510(k).

Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.

Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

A material mix-up had occurred during the manufacturing of Straumann¿ Custom Abutments. More specifically, a raw material bar of TAN-material (SAP #701924 / Lot 7130439) was incorrectly identified as a Titanium Bar Ti Gr4 D (SAP #701922 / Lot 7130430). As a result, RC Titanium abutments were manufactured using the TAN Bar material on Mill-from-Bar Machine 396-06.

The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. However, the individual surgical steps described in the surgical technique are correct.

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.