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FDA-Device2026-02-18Class IPROCESSING DEFECT

Medline reprocessed St. Jude Supreme diagnostic electrophysiology catheters recalled for residual particles

Medline
OTHERNationwide distribution

Stop using affected St. Jude Supreme catheters

Certain lots of reprocessed St. Jude Supreme and Response diagnostic electrophysiology catheters distributed by Medline may contain small particles of leftover material from reprocessing. If used in patients, these particles could cause blood clots, infection, or inflammatory reactions that may lead to serious complications including stroke or blood clots in the lungs or legs.

  • Check your facility's inventory against the affected lot numbers (EP250307 and EP250317)
  • Stop using any affected catheters immediately
  • Contact Medline or your hospital's medical device coordinator for instructions on device removal and patient notification
  • Report any patient injuries or complications to the FDA MedWatch program
Hazard

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

Sold states
Distribution US nationwide.
Affected count
48
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1322-2026

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