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Open, Classified

Reprocessed St. Jude Supreme and Response Diagnostic Electrophysiology Catheters: St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 2-5-2mm 401211RH 401222RH 401223RH 401226RH 401227RH 401260RH 401261RH 401306RH 401309RH 401312RH 401430RH 401433RH 401435RH 401441RH 401442RH 401443RH 401448RH 401449RH 401450RH 401451RH 401474RH 401860RH 401877RH 401878RH 401890RH 401891RH 401994RH; St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 5-5-5mm 402012RH; St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 5mm 402004RH; St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 6 Elec. 2-5-2mm 402010RH; St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 6 Elec. 5-5-5mm 402008RH 402009RH

FDA Recall Z-1322-2026 · Posted 2026-02-06

Recalling FirmMedline Industries, LP
Recall StatusOpen, Classified
Product CodeNLH
Date Initiated2025-12-22
Product Quantity48

Reason for Recall

These lots of reprocessed catheters may contain small particles of residual material. 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. Expansion of recall Z-2610/2614-2025

Firm Action

On December 22, 2025, the firm issued Urgent Medical Device Recall letters as a follow-up to an earlier action in 2025 for the same issue, but newly identified item numbers and lots of previously identified item numbers. Notably, the products associated with the new/updated action are to be destroyed by the customer on-site for credit, and not returned to the manufacturer. ***Updated 5/18/26*** The firm issued an expanded notification on 5/15/26 which expanded the action to include on additional lot of product. These devices were not expired at the time of the original notification but have since expired.

Root Cause

Under Investigation by firm

Distribution Pattern

Distribution US nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K241156Medline ReNewal Reprocessed St. Jude Medical Response Electrophysiology Catheter, Supreme Electrophysiology Catheter (401150, 401206, 401207, 401210, 401211, 401212, 401222, 401223, 401226, 401227, 401228, 401260, 401261, 401271, 401305, 401306, 401309, 401310, 401311, 401312, 401317, 401353, 401357, 401381, 401392, 401399, 401400, 401425, 401430, 401433, 401434, 401435, 401436, 401438, 401441, 401442, 401443, 401444, 401445, 401448, 401449, 401450, 401451, 401453, 401466, 401468, 401Surgical Instrument Service and Savings, Inc. · 2024-09-14

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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