|
July MedSun Newsletter
Recalls and Safety Alerts:
System CS100, CS100i and CS300 Intra-Aortic Balloon Pumps by Datascope: Field Correction
Datascope Corp. is voluntarily performing a worldwide field correction of certain Intra-Aortic Balloon Pumps (IABPs) for a potential electrical test failure code. This field correction also applies to any System 98 or System 98XT IABP that was converted to a CS100i or CS300 IABP...
Frameless Stereotaxic Navigation Systems: FDA Safety Communication
The FDA is aware that some health care providers have experienced navigational accuracy errors during surgical procedures when using frameless stereotaxic navigation systems. Some of these errors have led to patient deaths, serious or life-threatening injuries, and inaccurate, aborted, or prolonged medical procedures...
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, which may be toxic to tissues and organs (cytotoxicity) and 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. Falsely lower test results may lead to improper patient management and treatment for lead exposure or poisoning...
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...
| This email was sent to list-fda@xxxxxxxxxxx using GovDelivery Communications Cloud on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 1-888-INFO-FDA (1-888-463-6332) |
 |
| 
