Reprocessed St. Jude Supreme and Response Diagnostic Electrophysiology Catheters: St. Jude Medica
Pending LLM rewrite. Source: FDA_DEVICE Z-1322-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
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
The recalled product
- Product
- 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 40143
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 401211RH UDI-DI 10197344043736 Lot EP250317
- 401222RH UDI-DI 10197344043712 Lot EP250317
- 401223RH UDI-DI 10197344043705 Lot EP250317
- 401226RH UDI-DI 10197344043699 Lot EP250307 EP250317
- 401227RH UDI-DI 10197344043682 Lots EP250307 EP250317
- 401260RH UDI-DI 10197344043668 Lot EP250317
- 401261RH UDI-DI 10197344043651 Lot EP250317
- 401306RH UDI-DI 10197344043620¿ Lot EP250317
- 401309RH UDI-DI 10197344043613 Lot EP250317
- 401312RH UDI-DI 10197344043583¿ Lot EP250307
- 401430RH UDI-DI 10197344043491 Lots EP250307 EP250317
- 401433RH UDI-DI 10197344043484 Lots EP250307 EP250317
- 401435RH UDI-DI 10197344043460 Lots EP250307 EP250317
- 401441RH UDI-DI 10197344043439 Lots EP250307 EP250317
- 401442RH UDI-DI 10197344044245 Lot EP250307
- 401443RH UDI-DI 10197344044252 Lots EP250307 EP250317
- 401448RH UDI-DI 10197344044283 Lot EP250307
- 401449RH UDI-DI 10197344044290 Lot EP250307
- 401450RH UDI-DI 10197344044306 Lots EP250307 EP250317
- 401451RH UDI-DI 10197344044313 EP250307 EP250317
Distribution
Distributed nationwide across the United States.
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