Updated to reflect that there were 38 lot numbers identified in the recall, not part numbers.
The Chicago, Ill.-based company said that risks associated with the device include prolonged procedure times, the need to use another device or manual compression to achieve hemostasis.
The issue is due to exchange sheath material variations with a higher sheath split force which could result in difficulty or failure to deploy the device, according to the company. A total of 38 specific lot numbers internationally and 29 lot numbers in the U.S. were named in the recall, which is dated for Feb. 10.
Abbott said that there have been no long term or irreversible patient effects reported, and clarified that the recall does not affect patients who’ve successfully undergone procedures using the device.
The company said that customers with the device should contact the company to replace affected units, and that it was in contact with the appropriate regulatory bodies.
Last week, Abbot said that the FDA approved its RealTime ZIKA test to detect Zika virus in whole blood for emergency use. This is the 1st molecular test made by a commercial manufacturer that the federal watchdog has authorized to detect Zika in whole blood samples, the company touted.
Research suggests that Zika virus can be detected in whole blood for a longer period of time and at higher levels compared to serum and urine sample types, according to Abbott.