The United Kingdom issued a warning on potential failures with the therapy selector switch for the HeartStart XL defibrillator from Royal Philips (NYSE:PHG). According to a notice from the U.K. government, Philips’ defibrillator’s rotary therapy selector switch (energy select knob) may fail, resulting in unexpected device behavior that may include not switching on, not performing the […]
Endologix recall of abdominal stent graft system is Class I
Endologix (NSDQ:ELGX) is warning customers that material weakness during the manufacturing process is causing polymer leaks during implantation of its Ovation iX abdominal stent graft system. The FDA today gave the recall a Class I designation — its most serious level. Out of 12,763 Ovation iX systems sold between August 2015 and May 2020, there were […]
Abbott shares take hit after Goldman Sachs lowers rating
Abbott (NYSE:ABT) shares took a hit this week after Goldman Sachs reduced its rating on the stock to sell, from neutral. The dip also comes on the back of an urgent field safety notice warning on issues with the TactiCath quartz contact force ablation catheter. According to The Street, Goldman Sachs advised investors on June 1 […]
FDA issues Class 2 recall of da Vinci SP surgical system
The FDA confirmed that its recall of the da Vinci SP robotic surgical system from Intuitive Surgical (NSDQ:ISRG) is a Class 2 recall. Sunnyvale, Calif.-based Intuitive Surgical initiated its recall of 17 versions of device on April 1, 2019. According to the FDA database, the company became aware that the da Vinci SP system may trigger […]
Abbott issues urgent field safety notice over ablation catheter
Abbott (NYSE:ABT) has issued an urgent field safety notice to notify users of complaints about the TactiCath quartz contact force ablation catheter. The notice out of Germany, dated May 28, warns on complaints regarding a loss of contact force information while using the TactiCath product. This issue could cause ineffective ablation that could lead to atrial […]
Medtronic recall of DBS placement software is Class I
FDA said today that a Medtronic (NYSE:MDT) recall of software used to help place deep brain stimulation systems is Class I, the agency’s most serious level. The company in August 2019 recalled the auto-registration feature of its StealthStation DBS software due to inaccuracies caused by minor patient movements during the auto-registration process when used with NexFrame […]
Four deaths linked to Medtronic HeartWare recall
FDA has designated a Medtronic (NYSE:MDT) recall of its HeartWare HVAD Pump Outflow Graft and Outflow Graft Strain Relief as Class I — its most serious level. Medtronic, according to FDA, said the outflow graft of the HVAD Pump could tear and the strain relief screw may break during assembly prior to implant, but might not be […]
FDA labels Applied Medical catheter recall as Class I
The FDA announced today that the Applied Medical recall of multiple kinds of its catheters is designated as Class I, the most serious type of recall. The Python embolectomy catheters, Bard embolectomy catheters and the OTW Latis cleaning catheters were the types recalled by Applied Medical. A total of 19,400 devices were recalled in the […]
BD’s CME America suspends distribution of recalled infusion pumps
Becton Dickinson (NYSE:BDX) subsidiary CME America notified customers that it is suspending distribution of its recalled BodyGuard infusion pump system. In March, the FDA designated the CME America BodyGuard microset infusion sets recall as Class I — its most serious level — after complaints of under-infusion related to the sets. CME America initiated the U.S. recall […]
Vascular Solutions recall of Langston dual lumen catheter is Class I
The FDA issued a notice today warning that its recall of the Vascular Solutions Langston dual lumen catheter is identified as Class I, the most serious kind of recall. Vascular Solutions, a Teleflex (NYSE:TFX) subsidiary, designed the Langston dual lumen catheter for the rapid delivery of dye into blood vessels during medical imaging tests, allowing physicians to […]
Teleflex warns on Pilling Clear Advantage aortic punch
The United Kingdom today issued a safety notice to warn on the Pilling Clear Advantage aortic punch manufactured by Teleflex (NYSE:TFX). Teleflex recalled the Pilling Clear Advantage aortic punch in January after discovering the potential for compromised device packaging. If the packaging is compromised, the sterility of the device can’t be guaranteed, meaning use could result […]
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