Boston Scientific has issued a warning letter recalling some of its Hurricane RX biliary balloon dilation catheters. Marlborough, Massachusetts-based Boston Scientific issued the recall because of complaints received for pinholes in the balloon. The balloon could rapidly lose pressure or fail to maintain pressure due to the issue. The recall … [Read more...] about Boston Scientific recalls Hurricane RX biliary balloon dilation catheters
OmniVision launches cable modules for single-use endoscopes, catheters
OmniVision Technologies today announced that it has launched its OVMed OCHSA and OCHTA cable modules for single-use endoscopes and catheters. The Santa Clara, California-based company designed the medical-grade imaging subsystems with a small diameter camera module that is fully integrated with OVMed cables and mini-LED … [Read more...] about OmniVision launches cable modules for single-use endoscopes, catheters
Cook Medical issues voluntary recall for transseptal needles, transseptal needles with catheter
Cook Medical this week announced a global voluntary recall of its Transseptal Needle and Transseptal Needle with catheter. Bloomington, Indiana-based Cook Medical issued the recall due to complaints of rust on the products. The use of both products could result in increased procedural time and inflammatory reactions, including systemic reactions … [Read more...] about Cook Medical issues voluntary recall for transseptal needles, transseptal needles with catheter
Cordis recalls some Smart Flex vascular stent systems
Cordis recently issued a warning letter regarding an issue with its Smart Flex vascular stent system. Santa Clara, California-based Cordis's field safety correction action informs users that some of its Smart Flex vascular stents have the potential for distal tip dislodgment or separation due to inadequate adhesive application. The recall … [Read more...] about Cordis recalls some Smart Flex vascular stent systems
Pentax Medical expands Vizient contract to include pediatric endoscopes
Pentax Medical today announced it has expanded its contract with Vizient to include pediatric endoscopes. The contract will give Pentax Medical the ability to offer endoscopes to Vizient member hospitals through the Vizient Pediatric Program. The agreement also includes other value-added offerings, education opportunities and best … [Read more...] about Pentax Medical expands Vizient contract to include pediatric endoscopes
Stereotaxis touts positive results in robotic cardiac ablation study
Stereotaxis this week announced positive outcomes of an independent study assessing its robotic cardiac ablation system in pediatric patients. The St. Louis-based company's robotic technology demonstrated superior safety and efficacy in treating atrioventricular reentry tachycardia (AVRT) and atrioventricular nodal reentry tachycardia (AVNRT) in … [Read more...] about Stereotaxis touts positive results in robotic cardiac ablation study
Cook Medical warns on some Flexor Check-Flo introducer sheaths
Cook Medical recently issued a warning letter regarding an issue with its Flexor Check-Flo introducer catheters. Bloomington, Indiana-based Cook Medical's field safety corrective action informs users that some of its introducer sheaths may be manufactured incorrectly and that the radiopaque marker band may be located just below the Check-Flo … [Read more...] about Cook Medical warns on some Flexor Check-Flo introducer sheaths
Potrero Medical appoints medtech vet Steve Okland as chief commercial officer
Potrero Medical today announced that it has appointed Steve Okland as chief commercial officer. Prior to joining the sensory integrated foley catheter company, Okland has served on the leadership teams at Second Sight Medical and DryShield. He has also held sales and marketing leadership roles at Miramar Labs, Medivance, Spectranetics and Boston … [Read more...] about Potrero Medical appoints medtech vet Steve Okland as chief commercial officer
Boston Scientific announces positive data for Eluvia stent
Boston Scientific this week announced positive data for its Eluvia drug-eluting vascular stent system. Data presented this week included one-year results from the company's Eminent trial, which showed superiority of the Eluvia stent compared to self-expanding bare metal stents (BMS) to treat patients with peripheral artery disease (PAD) and … [Read more...] about Boston Scientific announces positive data for Eluvia stent
FDA clears expanded indications for BD’s Rotarex atherectomy system
BD this week announced that it has received FDA 510(k) clearance for expanded indications for its Rotarex atherectomy system. Franklin Lakes, N.J.-based BD designed the Rotarex as a rotational excision device that removes and aspirates varying lesion morphologies in the peripheral arteries. "The Rotarex atherectomy system is quick and … [Read more...] about FDA clears expanded indications for BD’s Rotarex atherectomy system
