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Recalls and Safety Alerts:
EpiPen and and EpiPen Jr Auto-Injector: RecallExpanded voluntary recall of select lots of these devices due to a potential defect in a supplier component. The potential defect could make the device difficult to activate in an emergency...
Prelude Short Sheath Introducer by Merit Medical Systems: Class I Recall
Recall due to a defect which may cause the tip to separate from the sheath during the insertion procedure. If this occurs, the tip could enter the patient's bloodstream...
Recall due to a defect which may cause the tip to separate from the sheath during the insertion procedure. If this occurs, the tip could enter the patient's bloodstream...
HeartStart MRx Monitor/Defibrillator by Phillips Healthcare: Class I Recall
Recall due to electrical and battery connection issues that may prevent the device from powering up, charging, and delivering an electrical shock therapy...
Recall due to electrical and battery connection issues that may prevent the device from powering up, charging, and delivering an electrical shock therapy...
Breast Implants: Update - Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)
FDA has updated its understanding of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) to reflect the agency’s concurrence with the World Health Organization designation of BIA-ALCL as a rare T-cell lymphoma that can develop following breast implants. At this time, most data suggest that BIA-ALCL occurs more frequently following implantation of breast implants with textured surfaces rather than those with smooth surfaces...
FDA has updated its understanding of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) to reflect the agency’s concurrence with the World Health Organization designation of BIA-ALCL as a rare T-cell lymphoma that can develop following breast implants. At this time, most data suggest that BIA-ALCL occurs more frequently following implantation of breast implants with textured surfaces rather than those with smooth surfaces...
Absorb GT1 Bioresorbable Vascular Scaffold (BVS) by Abbott Vascular: Letter to Health Care Providers
The FDA is informing health care providers treating patients with Absorb GT1 Bioresorbable Vascular Scaffold (BVS) that there is an increased rate of major adverse cardiac events observed in patients receiving the BVS, when compared to patients treated with the approved metallic XIENCE drug-eluting stent...
The FDA is informing health care providers treating patients with Absorb GT1 Bioresorbable Vascular Scaffold (BVS) that there is an increased rate of major adverse cardiac events observed in patients receiving the BVS, when compared to patients treated with the approved metallic XIENCE drug-eluting stent...
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