Product Recall

The FDA has designated a recall of a peripheral catheter system as class I, the most serious kind.

Abiomed is recalling specific left ventricular assist device sets used for people with cardiomyopathy due to customer complaints about purge fluid leaking from the sidearm of the pump, according to an FDA press release.

A recall of Medtronic’s Heartware ventricular assist device batteries has been designated as class I — the most serious type.

The FDA has designated Medtronic’s recall of its ventricular assist device batteries due to electrical faults causing battery failure as class I, the most serious type.

CorneaGen issued product recalls for certain corneal and scleral patch grafts, according to press releases from the FDA.

Medtronic has announced a recall of the delivery catheter component in the company’s transcatheter pulmonary valve system due to risk for capsule break during use.

Cardiovascular Systems Inc. announced a recall of its embolic protection device due to complaints of filter breakage during retrieval of lower limb blood clots associated with atherectomy procedures in lower limbs.

The FDA announced it designated a recall of intra-aortic balloon pumps due to problems related to fluid leak as class 1, the most serious type.

The FDA has classified Zimmer Biomet’s recall of a robotic platform for neurosurgeons as Class 1, the most serious type of recall.

Lupin is voluntarily recalling batches of irbesartan and irbesartan/hydrochlorothiazide tablets after an analysis revealed that certain tested active pharmaceutical ingredient batches had too much N-nitrosoirbesartan.