Medical Device Recall
FDA recalls Mercury Medical T-piece resuscitator due to ventilation control component
The FDA has recalled Mercury Medical’s Neo-Tee T-Piece Resuscitator, a gas powered resuscitator intended primarily for emergency use, due to an undersized spring in the ventilation control component.
Medtronic recalls MiniMed insulin pumps due to shorter-than-expected battery life
Medtronic has issued an urgent medical device correction letter warning users of the MiniMed 600 and 700 series of insulin pumps of an increased risk for shorter-than-expected battery life, according to an FDA press release.
Premarket research not conducted for many CV devices subject to class I recall
Many recently recalled cardiovascular devices did not undergo premarket testing prior to FDA approval, and postmarket studies of the devices were slow and infrequent, researchers reported.
FDA designates recall of catheter for large blood vessel clot removal as class I
Inari Medical has issued a recall and update to the instructions for use of its 30 mm thrombectomy catheter due to risk for injury and death from device entrapment and pulmonary emboli.
FDA designates recall of automated chest compression device as class I
Defibtech has issued a recall of its automated continuous chest compression device due to risk for the device to halt compressions during use.
FDA designates recall of display used with LV assist system as class I
Abbott issued a recall and correction for its left ventricular assist system monitor due to atypical behavior of the device screen that may cause unintentional pump stop.
Two intra-aortic balloon catheter kits recalled; three deaths reported
Teleflex and its subsidiary Arrow International issued a recall of its intra-aortic balloon catheter kits due to a manufacturing error that may cause the balloon to become overtwisted.
LVAD obstruction linked to 14 deaths; FDA designates recall as class I
Abbott/Thoratec Corp. issued a recall of two of its left ventricular assist devices due to risk for obstruction from the long-term buildup of biological material during use.
FDA designates recall of radial artery and arterial line catheterization kits as class I
Arrow International, a subsidiary of Teleflex, has issued a recall of its radial artery and arterial line catheterization kits due to increased resistance that may cause injury to the vessel wall, vasospasm, embolism or death.
FDA designates recall of left-sided blood pumps as class I
Abiomed has issued a recall of the instructions for use for its left-sided blood pumps, as the pump catheter may perforate the wall of the left ventricle or cause free wall rupture, hypertension, lack of blood flow or death.