Class I - Dangerous
Not manufactured to specification
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Implants & Prosthetics
🏥 Medical Devices • 4,589 recalls
Class I - Dangerous
Not manufactured to specification
Class I - Dangerous
Not manufactured to specification
Class I - Dangerous
Not manufactured to specification
Class I - Dangerous
Not manufactured to specification
VICI VENOUS STENT System Product Usage: is intended for the treatment of obstructions and occlusions in the venous vasculature.
Boston Scientific
Class I - Dangerous
The firm has received reports of stent migration after implantation
the firm discovered that, starting on April 1, 2020, a 3/8 dowel pin was used in place of the 5/8 pin. Over time, the shorter pin may not engage in either the upper or lower body, causing the cord to come loose or slip which could result in the loss of suspension.
Class I - Dangerous
The Gore post market surveillance team received a complaint that a GORE¿ VIABIL¿ Biliary Endoprosthesis appeared shorter than the labeled length.
Class I - Dangerous
The firm has received reports of stent migration after implantation
Class I - Dangerous
One batch of the ELUVIATM Drug Eluting Vascular Stent System incorrect placement of some 6x40mm ELUVIA stents into 6x100mm packaging.
Cobalt HF Quad MRI SureScan Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D) - Product Usage: are multiprogrammable cardiac devices that monitor and regulate a patient s heart rate by providing single- or dual chamber rate responsive bradycardia pacing, cardioversion, and defibrillation therapies.
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class I - Dangerous
The device may contain a manufacturing defect of a missing resistance spot weld (RSW).
ENDURITY Pulse Generator REF PM**** SN ********* St. Jude Medical Cardiac Rhythm Assurity and Endurity pacemakers are intended to provide single-chamber or dual-chamber bradycardia pacing.
St. Jude Medical, Cardian Rhythm Management Division
Class I - Dangerous
Due to a manufacturing issue associated with the mixing process of the epoxy used in the manufacture of pacemaker from years 2015 through 2018, the affected devices may malfunction caused by moisture ingress through the device header and feedthrough
Class I - Dangerous
Catheters may experience difficulty in flushing, infusion, and/or aspiration, and septum dislodgements.
Class I - Dangerous
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
Class I - Dangerous
Catheters may experience difficulty in flushing, infusion, and/or aspiration, and septum dislodgements.
Class I - Dangerous
Catheters may experience difficulty in flushing, infusion, and/or aspiration, and septum dislodgements.
ASSURITY Pulse Generator REF PM**** SN ********* ST. JUDE MEDICAL Assurity and Endurity pacemakers are intended to provide single-chamber or dual-chamber bradycardia pacing.
St. Jude Medical, Cardian Rhythm Management Division
Class I - Dangerous
Due to a manufacturing issue associated with the mixing process of the epoxy used in the manufacture of pacemaker from years 2015 through 2018, the affected devices may malfunction caused by moisture ingress through the device header and feedthrough
CareLink SmartSync Device Manager (24970A). used to interrogate cardiac implantable electronic devices (CIED).
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class I - Dangerous
There is a SmartSync software issue that results in an overestimation in the displayed longevity of these devices during an approximate 6-month window of time before the device triggers its Recommended Replacement Time (RRT).
DJO EMPOWR KNEE Femoral Sizer
Encore Medical
Class I - Dangerous
Incorrect assembly of a subcomponent by a vendor and as a result, the windows provided to show the size are facing the opposite direction.
Class I - Dangerous
There is a potential for unintended heating that can occur with the Intellis Model 97755 Recharger.