FDA Rates Medline Reprocessed Heart Catheter Removal Class I and Expands Product List

The US Food and Drug Administration said on March 5 that Medline Industries' removal of certain reprocessed electrophysiology and ultrasound catheters is a Class I recall, the agency's most serious type, and published a second notice covering an expanded set of products, according to the FDA's updated recall notice and its notice on the expansion, read in its March 6 version via the Internet Archive.

The catheters carry the names of other manufacturers and were reprocessed by Medline, which the FDA lists as Medline ReNewal devices. The FDA says use of the affected devices "may cause serious injury or death."

What the notices cover

The original notice lists reprocessed St. Jude Medical Livewire, Response and Supreme diagnostic electrophysiology catheters, the St. Jude ViewFlex ultrasound catheter, the Abbott Inquiry electrophysiology catheter, the Webster CS electrophysiology catheter and the AcuNav 8F ultrasound catheter. The FDA first flagged the problem in an Early Alert on August 6, 2025, and updated the page on March 5 to add affected products and the Class I classification, according to the page's timeline.

Medline sent customers an "Urgent Medical Device Recall" letter on July 14, 2025, and an updated letter to previously notified and additional customers on August 13, the FDA said. Those customers are told to quarantine affected lots, complete a response form and return the product to Medline.

The expansion notice covers lots named in a letter Medline sent on December 22. It adds the Biosense Webster SoundStar ultrasound catheter and the ACUSON AcuNav 10F ultrasound catheter to the list of affected Medline ReNewal devices. Unlike the earlier lots, product in the expansion is to be destroyed on site once the customer has completed the recall response, rather than returned.

Residual particulates

Medline stated that specific lots of the reprocessed catheters "may contain small residual particulates," according to both FDA notices. The FDA summarises the company's assessment of the risk: particulates on patient-contacting surfaces could lead to an inflammatory response or systemic infection, and particulate that dislodges into circulating blood or the heart may produce a granulomatous reaction or thrombus formation, which may lead to cerebral or pulmonary embolism or deep vein thrombosis.

As of December 12, Medline had not reported any serious injuries or deaths associated with the issue, the FDA said.

Electrophysiology diagnostic catheters are used for mapping, stimulation and recording of cardiac arrhythmias from inside the heart and blood vessels, according to the device-use section of the notices.

Recall records

The FDA links both notices to three recall events in its enforcement report and recall database, numbered RES98277, RES97496 and RES97357. Distributors that resold or transferred affected product are required by FDA regulations to pass on the recall communication to their own customers, the notice says.

Medline directs customers with questions about the recall to its recalls team, the FDA notices say.