Reprocessed EP catheters recalled due to contamination risk
Medline Industries, an Illinois-based manufacturer and distributor of medical supplies, is recalling specific lots of several electrophysiology (EP) catheters due to significant health risks. The devices, originally made by a variety vendors, may contain small traces of residual material that could potentially harm a patient.
“If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism or deep vein thrombosis,” according to the recalls.
The source of this residual material is still being evaluated by Medline Industries.
There are seven recalls in total, covering more than 1,800 catheters. The U.S. Food and Drug Administration (FDA) has categorized these as Class I recalls, which means using the devices is associated with a risk of serious injury or even death.
Unlike some recalls, the FDA is not asking that these devices be returned. Instead, customers are urged to destroy them immediately.
Medical devices included in these recalls:
- ViewFlex ICE Catheters – originally made by Abbott/St. Jude Medical
- Soundstar eco Diagnostic Ultrasound Catheter – originally made by Johnson & Johnson MedTech/Biosense Webster
- Acuson AcuNav Ultrasound Catheter – originally made by Siemens
- Inquiry Steerable Diagnostic Catheter – originally made by Abbott
- Livewire Steerable Electrophysiology Catheter – originally made by Abbott/St. Jude Medical
- Medline ReNewal Webster CS Catheter – originally made by Johnson & Johnson MedTech/Biosense Webster
- Supreme and Response Diagnostic Electrophysiology Catheters – originally made by Abbott/St. Jude Medical
Reprocessed single-use medical devises are a major part of the Medline Industries business model. The company estimates that this diverts more than 1 million pounds of waste from landfills each year. In addition to EP catheters, Medline Industries also reprocesses vessel sealers, compression sleeves and air transfer mattresses.
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.