Stryker (NYSE:SYK) recently issued a safety notice involving its Star total ankle replacement in which it warned of higher than expected risk of polyethylene fracture. The safety communication, dated Oct. 11, involved STAR total ankle replacements distributed before Aug. 1, 2014 — about the same time that Stryker acquired Small Bone Innovations and STAR (Scandinavian Total […]
Cardinal Health issues urgent field safety notice for Genius 2 and 3 thermometers
Cardinal Health (NYSE:CAH) has issued an urgent field safety notice to notify customers of a potential issue with the calibration of its Genius 2 and Genius 3 thermometers. The company said in the Oct. 30 notice that all Genius 2 tympanic thermometers manufactured after Oct. 1, 2016 were affected, along with all Genius 3 tympanic thermometers […]
Philips issues urgent field safety notice for V60 ventilators
Royal Philips (NYSE:PHG) issued an urgent field safety notice for its V60 ventilators after issues arose surrounding unresponsive touchscreens. In August, the Amsterdam-based company warned that the V60 ventilator’s touchscreen designed for changing certain therapy settings experienced problems with failure to respond to touch commands. The frozen screen can result in an inability to make changes […]
FDA puts Class I label on Zimmer Biomet’s Rosa Brain robot software recall
The FDA has given a recall on the Zimmer Biomet (NYSE:ZBH) Rosa Brain 3.0 devices for robot-assisted neurosurgery procedures a Class I designation, the most serious type of recall. Zimmer Biomet warned in September of the problem, in which a sequence workflow can trigger “a discrepancy between initial skin marking on the skull and instrument trajectory,” […]
Abbott recall of CentriMag circulatory support system designated as Class I
Updated Nov. 6 after FDA edited its notice to update on injury and fatality numbers. The U.S. FDA today issued a Class I designation — its most serious — over Abbott’s recall of its CentriMag circulatory support system. By the time Abbott (NYSE:ABT) initiated a recall in August 2019, there were already reports 44 injuries related […]
Coating snafu prompts recall of some Boston Scientific balloon catheters
Boston Scientific (NYSE:BSX) is voluntarily recalling certain dilation and extension catheters after finding that specific batches may have missed the hydrophilic coating step in the manufacturing process. That step is supposed to create a lubricious surface on the devices. Use of a catheter affected by the missed step could boost friction during delivery and withdrawal, delaying […]
Internal probe finds major problems at Ra Medical
Ra Medical Systems (NYSE:RMED) said yesterday that an internal investigation found failures surrounding its Dabra laser catheters among other shortcomings. The Carlsbad, Calif.-based company announced the investigation in August after allegations were raised by an employee and additional issues were uncovered over time. In the same announcement, the company ousted CEO, co-president & CTO Dean Irwin […]
Ethicon recalls Echelon Flex Endopath staplers
Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon yesterday issued a Class I recall of its Echelon Flex Endopath staplers after the product failed to completely form staples. Ethicon recalled the devices due to an out-of-specification component within the jaw of the stapler in some devices, which could lead to malformed staplers. If a problem isn’t recognized or addressed, […]
FDA warns on two more Endologix stent grafts
Updated on Oct. 29 with comments from Endologix. Endologix (NSDQ:ELGX) shares plummeted today after the FDA issued a warning for patients using the company’s AFX endovascular stent grafts for the treatment of abdominal aortic aneurysms. The AFX with Duraply and AFX2 were all mentioned by the FDA as stent grafts with a risk of endoleaks, along […]
Philips recalls defibrillators tied to 2 patient deaths
Philips has issued two separate recalls for its HeartStart XL+ defibrillator/monitor which may delay therapy and endanger patients. One recall relates to the device’s potential to fail to start or to unexpectedly try to restart and affects only devices sold outside the U.S. and Canada. It is associated with 588 customer complaints since 2011 and […]
Medtronic recalls certain Synchromed II pain pumps
This article has been updated with comments from Medtronic. Medtronic (NYSE:MDT) is recalling an unspecified number of its SynchroMed II implantable drug infusion pumps because of the possibility of malfunction. In a global urgent field notice to healthcare providers, the company said it received complaints about the pumps’ motors stalling permanently. A company investigation determined […]
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