FDA shares new safety concern with Medtronic catheters—warns of possible shortage in months ahead
The U.S. Food and Drug Administration (FDA) is warning the public about ongoing safety issues with a series of cannulae used to vent the left side of the heart during cardiopulmonary bypass surgery procedures. The agency’s alert includes dozens of lots of Medtronic’s DLP Left Heart Vent Catheters with malleable bodies and vented connectors.
The FDA put this early alert in place after receiving multiple reports of the catheters “resisting shape retention when being bent.” The devices were specifically designed to be easy to bend, holding their shape in a way that helps clinicians work in safe, efficient manner. When the devices fail to retain their shape, however, it can cause delays in care while a replacement catheter is located.
“If the issue is not identified prior to use and the clinician uses the cannula, it may lead to abrasion and perforation (cuts),” according to the FDA’s advisory. “Perforation of critical heart tissue may potentially lead to death if it is complicated, unnoticed or untreated.”
This issue has been linked to three serious injuries as of July 28. No patient deaths have been reported.
One of Medtronic's DLP Left Heart Vent Catheters. Image courtesy of the FDA.
Medtronic is requesting that customers quarantine all unused devices in their inventory and then return them to the company. While this issue has been corrected going forward, Medtronic did note that there may be “limited product availability for these items over the next few months.”
“If the product is unavailable, you may work with your sales representative to explore potential replacement options that Medtronic can offer,” according to the FDA’s advisory. “Alternatively, Medtronic will issue a credit note if a suitable replacement is not available.”
An ongoing trend
The FDA has been busy this season staying on top surgical device issues. Both Medtronic and Edwards Lifesciences have had to recall cannulae due to potential safety risks in the last few months.
As far as this latest issue is concerned, the FDA has not yet finished reviewing the available evidence. It is not yet clear if this will be ruled a Class I recall by the agency or not.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.