A Medical Device Daily
Guidant (Indianapolis), which has already recalled thousands of its pacemakers and defibrillators since last summer, reported that it is voluntarily cautioning physicians to check the voltage on certain Contak Renewal 3 RF and Contak Renewal 4 RF models of its implantable defibrillators.
Guidant said that the FDA may classify the notification to doctors as a product recall – decidedly not welcome news for a company trying to clean up its image and to complete its $27.2 billion merger with buyer Boston Scientific (Natick, Massachusetts), scheduled to happen in the first week of April.
The company said it received 39 reports from doctors saying that devices tested before being implanted had a lower-than-expected battery voltage. However, it noted that none of the devices were put into patients.
Guidant said about 4,000 of the affected devices have already been implanted, but it has not received any reports related to this particular issue for these implanted devices.
The company noted that an engineering investigation has confirmed that the observed decline in battery voltage is related to an unexpected, sustained, low-level current that can only occur during storage/shipment mode prior to implant.
The advisory reminded doctors to check their inventory for the defect and to always perform the voltage check before implanting the device.
In another regulatory action:
• BioSphere Medical (Rockland, Massachusetts) reported that it has instituted a voluntary recall of its HepaSphere Microspheres in Europe and Japan to correct a packaging defect that the company identified while conducting aging studies routinely performed on all its product packaging. This product began shipping in late 2005.
HepaSphere Microspheres, which are designed for hepaticarterial embolization, are contained in a prefilled vial that is in turn packaged inside a paper pouch.
The company determined that a defect in the paper pouch may compromise the sterility of the outside of the vial. If the sterility of the outside of the vial is not maintained, there is the risk that a physician's hands can become contaminated when handling the vial.
“This is strictly a packaging issue, not a product performance issue,“ said Gary Saxton, the company's executive vice president and COO. “We will correct the package defect as soon as possible to ensure that our HepaSphere Microspheres meet the highest standards of quality.“
The company said it is not aware of any adverse events resulting from the defects in the paper packaging and that sales of HepaSphere Microspheres outside of the U.S are expected to resume once a new packaging design is produced and validated.
BioSphere develops minimally invasive diagnostic and therapeutic applications based on bioengineered microsphere technology. Its principal focus is the treatment of symptomatic uterine fibroids using a procedure called uterine fibroid embolization.
Web site supports reducing catheter infections
A new online resource is now available – www.FirstDoNoHarm.com – for medical professionals concerned about reducing the incidence of catheter-related bloodstream infections (CRBSI). The web site is sponsored by Arrow International (Reading, Pennsylvania), a provider of central venous catheter products.
FirstDoNoHarm.com provides medical professionals access to news, clinical studies and research on topics related to catheter safety and CRBSI reduction, as well as access to current safety guidelines and standards. Arrow also has initiated “Catheter Mythbusters,“ a monthly e-mail bulletin.
“Arrow feels this online tool can help hospitals and healthcare workers reduce patient infection risk and increase safety in the critical care environment,“ said Richard Eagle, vice president of Arrow International's venous access unit.