Updated June 12, 2012, at 9:30 p.m. with comments from Cordis.
Johnson & Johnson (NYSE:JNJ) subsidiary Cordis Corp. launched an urgent product recall for a single lot of its Fire Star Rx PTCA dilation catheters over concerns that the devices may not deflate properly.
The affected lot of Fire Star catheters may exhibit "slow deflation or no deflation," according to a notice sent to healthcare providers in Hong Kong.
The recalled lot involves 292 units that were distributed in China, India, Indonesia, South Korea and Taiwan, Cordis spokeswoman Sandy Pound told MassDevice.com today.
The defect were reported to the FDA’s MAUDE database, with at least 4 adverse events logged for April and another 4 for March relating to difficulties deflating the Fire Star device.
"When the physician inflated the Fire Star balloon he could not deflate it," according to a report dated March 6, 2012. "So he had to use force to withdraw the balloon from the patient."
There have been no reported patient injuries or deaths, Pound told us. She later confirmed that the reports in the MAUDE database were the same events that spurred the recall in Asia and the affected devices came from the same lot included in the Hong Kong warning.
The new recall appeared similar to a U.S. withdrawal conducted in January 2008 which the FDA then dubbed "Class I," a category representing "the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death," according to the federal watchdog agency.
Pound noted that the new recall is not related to the same issue that preceded withdrawal in 2008.
"Cordis felt the prudent thing to do was to remove this lot from the field given its higher deflation complaint rate while we investigate the cause," she told MassDevice.com in an email.
"This has been reported as the same issue, but the limited numbers of complaint units returned to date have not shown any signs of obstruction or other reason for the slow deflation," Pound told us. "We are continuing to investigate further."
Pound added that the issue that preceded the new recall is not the same as the defect noted in 2008.
In the 2008 recall, Cordis noted that a swath of Fire Star Rx and Dura Star Rx devices had "a potential for slow deflation or no deflation of the angioplasty balloon when inserted into the artery or other blood vessels."
"This may potentially result in a total blockage of the artery or blood vessels, resulting in a change in the heart rate or heart rhythm, injury to the heart artery, a heart attack, need for a surgical procedure or death," according to the FDA recall notice.
That recall affected all lots of the Fire Star and Dura Fire devices manufactured in Mexico from February 2007 through December 2007, which were distributed worldwide from March 2007 through January 2008, according to the report.
Balloon catheters are used to open narrowed or blocked blood vessels or arteries in the heart during a procedure known as percutaneous transluminal coronary angioplasty.
Representatives at Cordis Corp. did not immediately respond to requests for comment.