On the heels of a permanent injunction from the Department of Justice that resulted in the cease of manufacturing at one of Maquet's facilities, the suspension of 5 of its devices from the market and a $6 million fine, the FDA just warned practitioners that the company's Flow-i Anesthesia Systems have a problem that "may cause anesthesia gas to leak and could prevent the ventilator from providing breathing support if not corrected immediately."
Teleflex Medical is in the process of recalling 9,333 units of its Hudson RCI manual ventilator for emergency resuscitation because "the intake port may be blocked which can cause the bag to fail to fill," according to the FDA's recall database.
HeartWare will replace the controllers of all 3,747 of its artificial blood pumps, marking its fifth corrective action of the year deemed a Class 1 recall by the FDA. Class 1 recalls are reserved for situations in which the agency believes there is a reasonable probability that use of or exposure to the device "will cause serious adverse health consequences or death."
The FDA added three Class 1 recalls to its database this week, reserved for situations in which the agency believes exposure to the faulty device "will cause serious adverse health consequences or death."
Baxter has recalled a patch used in peripheral vascular reconstruction surgeries. The move to recall almost 4,000 of these products in the U.S. is due to a new packaging configuration that is confusing users as to how to orient the patch correctly.
CareFusion's Avea ventilator was just hit with a Class 1 recall from the FDA, meaning the agency believes there is a reasonable probability that exposure to or use of the 15,905 violative devices "will cause serious adverse health consequences or death."
Medtronic's Covidien was hit with a recall of 1,661 units of its VenaSeal Sapheon Closure System, a procedural delivery system for an adhesive that treats venous reflux disease by closing the affected veins in the lower leg.
The FDA halted the manufacture of Medtronic's SynchroMed II Implantable Infusion Pump Systems, citing repeatedly failing to correct violations of the agency's quality system regulations in a consent decree filed against company CEO Omar Ishrak and Senior Vice President Thomas Tefft.
On the heels of a permanent injunction from the Department of Justice that resulted in the cease of manufacturing at one of its facilities, the suspension of 5 of Germany's Maquet Holding's devices from the market and a $6 million fine, the FDA announced the recall of all 4,154 units of its stroke-fighting TigerPaw System II left atrial appendage closure device.
There were 426 medical device recalls in the first quarter of this year, according to FDA's recall database, down from a record high of 968 in Q4 2014.