Minnesota medical device giant Medtronic (NYSE:MDT) was the 1st to notify doctors of potential issues with certain of its deep-brain stimulation implants, but the FDA’s response to the warning may have been something of an overreaction, according to some observers.
Recalls
FDA gives Covidien recall highest-risk label
The FDA this week put its highest-risk label on medical device maker Covidien’s (NYSE:COV) recent ventilator battery recall, warning that the device may cause patients harm.
Medtronic warns on wire damage risk with deep-brain stimulation implants
Medtronic (NYSE:MDT) warned physicians of the potential for the wires used with its deep-brain stimulation implants to be damaged during implantation, prompting the FDA to label Medtronic’s "Urgent Medical Device Correction" as a Class I recall – denoting a device with the potential to cause severe injury or death.
Hospira slides after taking $134M charge on infusion pump phase-out
Medical device recalls for April 2013
Class I recalls
Recalling Manufacturer, Date Posted, Trade Name/Product, Reason for Recall
Recall: FDA issues Class 1 recall for Hospira’s GemStar infusion system battery
Another Alaris recall for CareFusion
The FDA classified the recall of CareFusion‘s (NYSE:CFN) Alaris PC software as Class I, the federal watchdog agency’s most serious recall level denoting the risk of serious injury or death.
The problem occurs with CareFusion’s Alaris 8015 running the 9.12 software version, with affected units displaying communication errors when attached to EtCO2 or SpO2 modules.
Update: Cook Medical recalls Zilver PTX delivery system following patient death
Updated April 25, 2013 with additional comments from Cook Medical.
Cook Medical recalled all sizes, diameters and lot numbers of its Zilver PTX drug-eluting stents after receiving reports of 1 death and 1 patient injury possibly associated with a breakage in the catheter delivery system. It’s not clear when the devices will be back on the market, according to a company spokesman.
Recall, DoJ probe push Stryker’s Q1 profits down 13%
Stryker (NYSE:SYK) said the recall of some of its hip implant components and a U.S. Justice Dept. probe into its OtisKnee device helped push 1st-quarter profits down 13%, but still managed to beat Wall Street analysts’ expectations.
Kalamazoo, Mich.-based Stryker posted profits of $304 million, or 79¢ per share, on sales of $2.19 billion during the quarter, amounting to 1.3% sales growth.
There’s an app for that: FDA crowd-sources adverse event reporting
GE warns on certain Giraffe infant care systems | MassDevice.com On Call
MASSDEVICE ON CALL — GE Healthcare (NYSE:GE) warned that some of its Giraffe Incubator and OmniBed systems contain a faulty component that may pose a risk to patients.