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June MedSun Newsletter
Recalls and Safety Alerts:
SpF PLUS-Mini and SpF XL IIB Implantable Spinal Fusion Stimulators by Zimmer Biomet: Class I Recall
Recall due to higher than allowed levels of potential harmful chemicals that were found during the company's routine monitoring procedure…
LeadCare Testing Systems (with Blood Obtained from a Vein) by Magellan Diagnostics: FDA Safety Communication
Affected devices may underestimate the blood lead levels (BLL) and give inaccurate results when processing venous blood samples…
HeartMate II LVAS Pocket System Controller by Abbott-Thoratec: Class I Recall
Patients may sometimes need to change to their backup back-up system controller during the course of ventricular assist therapy. The change should be done quickly and in the hospital, because it can present a significant challenge to patients that are elderly and/or untrained. For these patients, a slow or improper driveline changeover places them at risk of serious injury or death…
V60 Non-invasive Ventilator by Respironics: Class I Recall
Pins within the internal cable that connects the ventilator's motor to the control board may become loose over time due to low frequency vibration. The loose pins may prevent data to be transferred between the motor and the control board, triggering the ventilator to shut down unexpectedly and to sound an alarm...
Wingman35 Crossing Catheters by ReFlow Medical: Recall
Affected devices have been found to exhibit tip splitting or separation, which has resulted in two adverse events. Tip splitting has the potential to lead to loss of device function. Tip separation may require medical intervention to retrieve a separated segment or may occlude blood flow to end organs…
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