Class I - Dangerous
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
Abbott
19 recalls • • Categories: Surgical Instruments, Infusion Pumps, Other Medical Devices, Implants & Prosthetics, Diagnostic Equipment
Class I - Dangerous
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
Class I - Dangerous
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
Class I - Dangerous
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
Class I - Dangerous
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
Class I - Dangerous
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.
Class I - Dangerous
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.
Class I - Dangerous
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.
Class I - Dangerous
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.
Class I - Dangerous
When connected to the EnSite Precision Navigation System, an affected TactiCath Contact Force Ablation Catheter, Sensor Enabled may present the error message: "invalid catheter,, or "expired catheter."
Class I - Dangerous
Incorrect product labeling.
Class I - Dangerous
Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the use of the single-use device.
Class I - Dangerous
Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the use of the single-use device.
Class I - Dangerous
Instructions for use were updated.
Class I - Dangerous
As a result of a manufacturing error, one (1) lot of Ultimum Hemostasis Introducer devices was manufactured with an incorrect hub and overall length. The devices manufactured were 12 cm in length instead of the intended 5 cm in length.
High rate of reported complaints for the loss of contact force information while using the TactiCath Quartz Contact Force Ablation Catheter
Internal testing of software identified software anomaly scenarios where if non-applicable shock energy value is selected, the device will continue to use the previously programmed energy level and the user will not be alerted that the selected value was not retained.
The device is unable to pair with the mobile app due to the device incorrectly determining the certificate has expired.
Reports of outflow graft twist occlusions. Patients whose devices experience outflow graft occlusions will experience a persistent low flow alarm. Outflow graft occlusions can result in serious adverse events such as hemodynamic compromise, thrombus, and death.