Medline Industries, Lp: Catheter, Recording, Electrode, Reprocessed

Recall Summary St. Jude Medical reprocessed electrophysiology catheters (model numbers 401206RH and 401305RH) are being recalled because some lots may have small particles of residual material left on surfaces that contact patients. These particles could cause inflammation, infection, blood clots, or other serious complications if they enter the bloodstream or heart during use. The affected devices were distributed nationwide.

Recalling firm: Medline Industries, LP
Product: Reprocessed Electrophysiology Catheters and Ultrasound Catheters Item no. 401206RH, St. Jude Medical Response" Diagnostic Electrophysiology Catheter 4 Elec. 10mm; Item no. 401305RH, St. Jude Medical Response" Diagnostic Electrophysiology Catheter 10 Elec. 2-5-2mm.
Reason: Expansion of RES 98277. Specific lots of reprocessed catheters may contain small particles of residual material. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection. If particulate were to dislodge during use and contact circulating blood or the heart, it may produce a granulomatous reaction or thrombus formation, which may lead to cerebral or pulmonary embolism, or deep vein thrombosis.
Classification: Class II
Category: medical device recall
Country: United States
Agency: FDA-DEVICES
Recall date: 2026-05-15
Status: Open, Classified
Areas affected: AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
Distribution: US Nationwide distribution in the state of TX.

Recall details on Nibble Recalls: https://trynibble.app/recalls/22a4c258-6122-48d1-9658-0609de162a90