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.
FDA Recall Z-2615-2026 · Posted 2026-07-02
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Recalling FirmMedline Industries, LP
Recall StatusOpen, Classified
Product CodeNLH
Date Initiated2026-05-15
Product Quantity3
Reason for Recall
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.
Firm Action
This is an expansion of recall RES 98277. On May 15, 2026, firm notified affected consignee via letter titled "URGENT MEDICAL DEVICE RECALL". All affected product has expired.
The consignee was instructed to quarantine all affected product and destroy it.
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide distribution in the state of TX.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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