Medical Device Recalls: FDA Device Safety Alerts And Recall Notices

Retrospective review of servicing records identified AIC units requiring various hardware, firmware, and/or software update(s): 1. RFID firmware issue that may result in failure of the AIC to recognize the purge cassette during case setup or cassette change. This issue may result in delay in procedure or therapy. 2. Potential for the rotary push button (RPB) sticking and unreliable actuation impacting operator ability to select and confirm menu entries. This can result in loss of control of the console. 3. Potential AIC instability that could result in AIC start-up failure, inability to drive the pump, and the need for console exchange. 4. Software defect related to calculator process crash, leading to Negative Central Venous Pressure (CVP) values present in Pulmonary Artery Pressure (PAP) calculations.

Software problem has the potential for an inaccurate displayed longevity estimate.

Due to software issue, X-ray interventional system may experience internal error if F-Store or imagine acquisition is performed while clinical analysis function is use.

Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which may include reduced reliability over time such as loss of imaging functionality or motorized movement, a blank or black display, and/or the inability to store newly acquired images or access previously acquired images.

Retrospective review of servicing records identified AIC units requiring various hardware, firmware, and/or software update(s): 1. RFID firmware issue that may result in failure of the AIC to recognize the purge cassette during case setup or cassette change. This issue may result in delay in procedure or therapy. 2. Potential for the rotary push button (RPB) sticking and unreliable actuation impacting operator ability to select and confirm menu entries. This can result in loss of control of the console. 3. Potential AIC instability that could result in AIC start-up failure, inability to drive the pump, and the need for console exchange. 4. Software defect related to calculator process crash, leading to Negative Central Venous Pressure (CVP) values present in Pulmonary Artery Pressure (PAP) calculations.

Affected leads require additional engineering evaluation due to complaints regarding difficulty in achieving fixation during implantation. Potential harm of tissue trauma due to implant difficulty.

The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.

Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.

Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.

A routine stability studies have identified a stability drift affecting the Ammonia (NH4+) analyte in specific lots of Multichem AE quality control material. Additional testing confirmed that the labelled shelf-life performance claim for the Ammonia analyte can no longer be supported for the affected lots. This issue is limited to the Ammonia analyte only. The impacted device may cause delay of issuing results to the physician. Delayed recognition and diagnosis of elevated levels may impact in timely treatment of life-threatening levels described within medical toxicity intervention decision points.

The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.

Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.

The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.

Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.

Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.

Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.

Wrong lead or percutaneous extension selected. Use of an incompatible lead or percutaneous extension will prevent the system from working as intended and may result in delay of surgery or need for surgical replacement of the product.

The radiopaque material may detach from the marker. In some cases, artifact was noted and attributed to the detached material.

The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.

The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.

Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.

Implants were found in the field with orange sterilzation indicators which means implants were not exposed to sterilization.

The affected products bear an incorrect statement on the carton packaging indicating that the product is "Indicated for Extended Wear". However, this product is intended for daily wear, and the extended-wear statement should not have appeared on the affected carton labeling. This product is not approved by the U.S. Food and Drug Administration (FDA) for extended wear use.

Reports of problems with product being difficult to remove from patient and leaving adhesive residue on patient's skin.

The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.