FDA recalls Maquet, Millar vascular devices

April 1, 2011 By MassDevice staff

The FDA recalled vascular devices made by Maquet Cardiovascular LLC and Millar Instruments Inc.

The federal watchdog agency classified the recalls as Class I, its most serious level of product clawback, indicating a reasonable probability that the use of the recalled product "will cause serious adverse health consequences or death."

The recalled Marquet device is the Heartstring II proximal seal system, model number HS-1045, for which the company sent out an "Urgent Device Removal" letter on May 5, 2010. The FDA posted the Class I recall notice on its website yesterday. The recall affects lot numbers 12895788, 12946718, 25002866, 25004647, 13029141, 25005045 and 25005622, distributed from Sept. 2009 through April 2010, according to the FDA.

The Wayne, N.J.-based company’s Heartstring II is designed to help control the flow of blood in the aorta during coronary artery bypass surgery. It gives surgeons the ability to create an important connection between blood vessels (proximal anastomosis) without the use of an aortic clamp, according to the FDA. The device was recalled because its deployment tube may detach during use.

Millar pulled its Mikro-Tip angiographic catheter off the shelves and notified its customers of a possible defect in the device earlier this month.

The Houston-based company found that the lumen component of models SPC-454D and SPC-454F of its angiographic catheter contain particulates that could enter the blood stream and cause heart attack, stroke, limb ischemia and death.

A total of 965 catheters were distributed internationally and 115 catheters were distributed to Millar customers in California, Washington, D.C., Massachusetts, Michigan, Minnesota, New York and Pennsylvania.

The FDA also posted the Class I recall notice for the Millar catheter March 31.

Steris wins second EUA to decontaminate up to 30m respirators per day
Steris (NYSE:STE) has won an FDA emergency use authorization (EUA) for a new steam sterilization method to decontaminate used N95 respirators. The EUA covers the new Steris Steam Decon cycle to decontaminate 3M 1860, 3M 1860S, and 3M 1804 NIOSH-approved N95 respirators that are or might be contaminated with SARS-CoV-2 and other pathogenic microorganisms. The FDA… […]
Raumedic supplies adhesive for production of thousands of ventilators
When the federal government tapped Hamilton Medical to produce tens of thousands of ventilators for COVID-19 patients, the company turned to its long-term partner Raumedic for a special silicone adhesive. The adhesive is solvent- and plasticizer-free, easy to use and bonds silicones to each other and to other materials, such as metal or plastics, according… […]
FDA signals PPE shortage, issues EUA for more
The FDA has issued a call for manufacturers to produce more non-surgical gowns and other personal protective equipment (PPE) as the coronavirus pandemic makes its way across the country. The emergency use authorization issued Friday also listed conductive shoes and shoe covers, operating room shoes and shoe covers, surgical helmets and caps and other surgical accessories. The… […]
Ga. warehouse workers sue Sterigenics, ConMed over EtO exposure
Fifty-three people who worked in an Atlanta-area warehouse that stored medical devices sterilized by ethylene oxide (EtO) filed suit this week against Sterigenics and its parent company over exposure to the gas. The plaintiffs or their families claim that long-term EtO exposure to the sterilized devices, which they unloaded, handled, warehoused and distributed, caused multiple… […]
FDA eases regs on certain device changes during pandemic
The FDA will allow limited changes to certain devices so medtech companies can address manufacturing and supply chain issues due to COVID-19-related disruptions. In a guidance released yesterday, the agency said it would allow changes to devices approved through its premarket approval (PMA) and humanitarian device exemption (HDE) pathways as long as those changes do… […]
15 heart devices that could boost their manufacturers’ sales
Before the coronavirus pandemic hit, medtech companies large and small were making notable news with a number of innovative heart devices. Some of these same companies took a big hit to their bottom lines when the danger of spreading COVID-19 and using up precious personal protective equipment convinced hospitals to limit non-urgent procedures. Now hospitals… […]
This wearable could help people practice safe distancing amid COVID-19
Imec spinoff Lopos, with the Ghent University (Belgium) announced the Lopos SafeDistance wearable for promoting safety during the COVID-19 pandemic. As businesses attempt to return to in-person activities, the collaboration designed the wearable device to warn employees through an audible or haptic alarm when they are violating social distancing guidelines as they approach each other.… […]
FDA launches COVID-19 research initiative
The FDA has entered an agreement with healthcare analytics company Aetion to research urgent questions about COVID-19. The New York City-based company said the research will support FDA objectives to explore the natural history of the disease, as well as treatment and diagnostic patterns using relevant, novel data sources and analyzing these data according to well-established principles.… […]
Medtronic execs see quick recovery, increased M&A
If Medtronic’s troubling Q4 report offers a snapshot of a company hit hard by COVID-19, the next image in the sequence may show a faster-than-expected recovery and increased merger-and-acquisition of smaller companies. In the quarterly call on Thursday morning, Medtronic CEO Geoff Martha and CFO Karen Parkhill expressed optimism that the company’s businesses already are showing signs… […]
Webinar: How COVID-19 is changing medical device regulation, clinical trials and reimbursement
Tuesday, June 23, 2020 11:30 a.m. eastern time / 8:30 a.m. pacific time As the life sciences industry works to contain the COVID-19 outbreak, it is clear that the dynamics of the medical device and digital health industries are being disrupted. Going virtual is the new normal and executives of medtech and healthtech… […]
IMDRF recommends UL 2900 compliance for medical device cybersecurity
By Stewart Eisenhart, Emergo Group Recent guidance published by the International Medical Devices Regulators Forum (IMDRF) that covers medical device cybersecurity best practices includes recommendations that manufacturers comply with the UL 2900 set of standards for network-connectable devices. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post… […]