Abbott has recalled some of its coronary catheters, following reports of difficulty in removing their protective balloon sheath. The problem may have led to one patient’s death.
Products named Abbott’s catheter recall include the company’s:
As many as 449,661 lots could be affected by the recall. Those included were manufactured between January 1, 2015 – January 2, 2017, and were distributed between January 13, 2015 – March 14, 2017. A complete list of lot numbers can be found in Abbott’s March 22nd Field Safety Notice.
According to an alert dated May 16th, the U.S. Food & Drug Administration (FDA) has identified Abbott’s action a Class I recall. Class I is the agency’s most serious recall category, and indicates that a medical device poses a risk of serious injury or death.
“Potential risks associated with balloon inflation and deflation difficulties include air embolism, additional intervention, thrombosis, and myocardial infarction,” the FDA said. “In one reported case, failure to deflate the balloon necessitated surgery, which resulted in multiple post-surgical complications leading to death.”
“The cumulative frequency of reported events in difficulty of removing the sheath and inflation and deflation of the balloon is 0.12%,” Abbott said in a press release issued on May 12th. “This recall does not affect patients who have successfully undergone cardiac procedures using these devices.”
The company noted that corrective actions have already been taken to ensure the catheters perform as intended. Abbott’s customers were notified to cease using the products and have confirmed that they are no longer in use.
Abbott’s catheter recall comes nearly two years after Cook Medical, Inc. recalled thousands of Beacon Tip Catheters due to an issue with tip splitting and separation. Tip splitting could cause the device to stop functioning as intended, while splitting or separation could allow the catheter to enter the patient’s blood stream. Prior to the recall, Cook Medical had received 26 reports of catheter malfunction, 14 of which resulted in adverse events.
The FDA also designated the Beacon Tip Catheter recall a Class I recall. Affected devices included:
Some 90,000 catheters were subjected recall. The affected devices were manufactured from May 9, 2013, to September 1, 2014, and distributed from June 6, 2013, to June 25, 2015. A complete list of lot numbers can be found here.
Adverse events or complications that may be related to either of these catheter recalls can be reported to: www.fda.gov/MedWatch/report.