Update: FDA announces new Class I recalls due to safety issue with Medtronic catheters
The U.S. Food and Drug Administration (FDA) has announced three new Class I recalls related to safety concerns with multiple cannulae used during cardiopulmonary bypass surgery procedures. The recalls include dozens of lots of Medtronic’s DLP Left Heart Vent Catheters with malleable bodies and vented connectors.
The FDA first warned the public about this issue in August after receiving reports of these 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 they fail to retain their shape, it can delay care while a replacement catheter is located.
The three Class I recalls cover more than 101,000 Medtronic catheters. As of July 28, three serious injuries had been linked to these concerns.
One of Medtronic's DLP Left Heart Vent Catheters. Image courtesy of the FDA.
Medtronic is urging customers to review their inventory for any products that may be part of these recalls. Any unused, listed products should be immediately quarantined.
“Although the issue has been corrected for newly manufactured lots, please be aware that Medtronic will have limited product availability for these items over the next few months,” according to the recalls. “If the product is unavailable, you may work with your sales representative to explore potential replacement options that Medtronic can offer. Alternatively, Medtronic will issue a credit note if a suitable replacement is not available.”
The FDA has determined that these recalls are a result of "process change control." Additional details from the agency are available here, here and here.
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.