MASSDEVICE ON CALL — Medtech giant Philips Healthcare (NYSE:PHG) got renewed attention for its troubled HeartStart automated external defibrillators after the FDA this week issued a new warning letter over potentially faulty electrical components.
Recalls
Diabetes: Abbott recalls blood glucose test strips
Abbott Diabetes Care (NYSE:ABT) said it issued a recall of its FreeStyle blood glucose test strips after reports of falsely low results.
Another Class I recall for Hospira’s GemStar infusion system
Preventing medical device recalls: What’s expected for internal audits?
Nancy Singer for Sparta Systems
Johnson & Johnson confirms $2.5B hip lawsuit settlement, consumers group wants more
Medtronic’s guidewire recall gets FDA’s highest-risk label | MassDevice.com On Call
MASSDEVICE ON CALL — Medical device titan Medtronic (NYSE:MDT) announced late last week that the FDA had put its highest-risk label on a company recall of certain guidewires. The agency deemed the recall a "Class I" issue, reserved for device defects that could "cause serious adverse health consequences or death."
Maker of recalled breast implants on the hook for damages | MassDevice.com On Call
MASSDEVICE ON CALL — A French court this week ruled in favor of a slate of patients that a medical device inspection services provider must repay patients affected by a high-profile recall over sub-par breast implants.
Report: Johnson & Johnson to settle DePuy ASR claims for $4B
Johnson & Johnson (NYSE:JNJ) is said to be close to settling the thousands of pending and future lawsuits involving its recalled DePuy ASR metal-on-metal hip implants, according to Bloomberg.
Anti-Essure movement grows online as women slam Bayer’s implant | MassDevice.com On Call
MASSDEVICE ON CALL — The anti-Essure movement, launched by women who claim the permanent contraceptive implant left them with severe pain and injuries, doesn’t look likely to die down, having spawned Facebook support pages, Twitter campaigns and lots of media attention.
The movement has attached itself to the Twitter hashtag ‘#EssureRally’, through which women are calling on Bayer to recall the device, posting pictures of the ralliers in action and organizing real-world events, including street-corner picketing and conference calls with famed consumer advocate Erin Brockovich.
FDA: Baylis Medical recall is Class I
The FDA put a Class I label on Baylis Medical’s recall of its TorFlex transseptal guiding sheath kit, the federal watchdog agency announced.
The recall was issued because the sheath could remove particulate of less than 5mm from the dilator and the particulate could end up in the bloodstream, the FDA said.