Recall of reprocessed St. Jude Supreme and Response Diagnostic Electrophysiology Catheters due to potential residual material causing infection or inflammation. Affected units include specific model numbers and lots.
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
Medline Industries is recalling certain reprocessed St. Jude Supreme and Response Diagnostic Electrophysiology Catheters. These devices may contain small particles of residual material that could cause infections, inflammation, or serious blood clots if used.
Reprocessed catheters may have small particles of residual material that, when used, can cause an inflammatory response, infection, or blood clots. This could lead to serious complications like pulmonary embolism or deep vein thrombosis.
Healthcare professionals who use these catheters for diagnostic procedures are most at risk. Patients receiving these devices during procedures may also be affected.
Check for model numbers like 401211RH, 401222RH, or 402012RH with specific lot numbers (EP250317, EP250307) from the list provided in the recall notice.
Look for model numbers such as 401211RH, 401222RH, or 402012RH on the catheter packaging or label.
Reach out to Medline Industries for confirmation of affected units and instructions on next steps.
These reprocessed catheters may contain small particles of residual material that could cause inflammation, infection, or blood clots leading to serious complications like pulmonary embolism or deep vein thrombosis.
Affected models include 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, 402004RH, 402008RH, 402009RH, 402010RH, and 402012RH with specific lot numbers.
The recall does not require immediate discontinuation; healthcare professionals should check model numbers and contact Medline Industries for guidance.
We’ve drafted a message you can send St. Jude Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1322-2026 — St. Jude Medical St. Jude Medical Hello, I own a St. Jude Medical that is covered by recall Z-1322-2026 from St. Jude Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
