Search Results for 'recalls'

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Cardiovascular

Abbott Recalls Ellipse ICDs

The ICDs were recalled due to exposed aluminum wires that may prevent defibrillation therapy.

U.S. Food and Drug Administration 08.05.19
GE Healthcare Recalls Giraffe and Panda i-Res Infant Warmers

The bedside panels and latch areas on the beds may crack, break, or become damaged if the unit is not properly used.

GE Healthcare 07.11.19
BD Recalls SmartSite Syringe Administration Set Due to Risk of Leaks

Leaks could result in under-infusion, delay or interruption, and/or contamination.

U.S. Food and Drug Administration 07.02.19
Edwards Recalls Intra-Aortic Occlusion Device Over Balloon Rupture Risk

The IntraClude balloon bursting may cause serious adverse health consequences related to increased time the patient is on cardiopulmonary bypass.

U.S. Food and Drug Administration 07.02.19
Cardiovascular | Surgical

Cook Recalls PTA Balloon Catheters Due to Balloons Bursting

Multiple complaints were received for balloons in Cook's Advance Enforcer 35 Focal Force PTA Balloon Catheter bursting below the rated burst pressure.

U.S. Food and Drug Administration 06.19.19
Cardiovascular | Surgical

Terumo Recalls Two Sheaths Over Dislodgment Risk

The company has acknowledged a potential for the tip to dislodge from the outer rim of the sheath.

U.S. Food and Drug Administration 05.30.19
Surgical

Vyaire Recalls Tri-Flo Subglottic Suction System Due to Risk of Device Breakage

There is a risk that the distal soft tip of the catheter may break off and enter the patient's lungs.

U.S. Food and Drug Administration 09.05.18
Cardiovascular | Surgical

Abbott Recalls HeartMate 3 LVAD Due to Potential Graft Occlusion

Malfunction in the device's outflow graft assembly may cause the outflow graft to twist and close up over time.

U.S. Food and Drug Administration 05.23.18
Electronics

Oscor Recalls Extension Cables Due to Risk of Cable Separation from Connector

Detachment of extension cable and connectors can result in a delay and/or failure of cardiac pacing therapy for the patient.

U.S. Food and Drug Administration 07.24.17
Software & IT

Proactive Risk Management to Reduce Recalls in the Life Sciences

Recalls are serious issues that plague the life sciences industry with many potential negative consequences. They can cost organizations large amounts of time and money, as well as negatively impact brand image and customer trust. At their worst, imp…

Alexa Sussman, Content Marketing Writer, EtQ 10.12.16