Medline recalls surgical kits due to safety concern with Medtronic catheters
Medline is recalling certain surgical kits as a response to ongoing safety issues with multiple cannulae used during cardiopulmonary bypass graft (CABG) surgery procedures, according to a new update from the U.S. Food and Drug Administration (FDA).
The surgical kits in question contain a mix of accessories, including Medtronic’s DLP Left Heart Vent Catheter. Medtronic recalled those catheters, however, after receiving multiple reports that they were “resisting shape retention when being bent.” As of July 28, 2025, Medtronic has received 41 complaints due to this problem. It has also been linked to three serious patient injuries.
The FDA first warned the public about this risk in August. The agency later announced three new Class I recalls due to the issue.
“The potential harm when identified prior to use is procedure delay while another cannula is located,” according to the new advisory. “If this is not identified prior to use, and the clinician uses the cannula, the potential harms are abrasion and perforation (major or critical). Medtronic has not received any complaints resulting in patient death; however, perforation of critical heart tissue—if complicated, unnoticed, or untreated—may lead to the potential risk of death.”
What should customers do?
Medline has emphasized that these Medtronic catheters should not be used to treat patients. In addition, any unused surgical kits containing the catheters should be set to the side so that they can eventually be destroyed.
“If you are a distributor, or if you have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication,” according to the new advisory. “Please request that customers destroy any affected product. You should include your customers’ quantities on your response form.”
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.