[pending] Reprocessed St. Jude Supreme and Response Diagnostic Electrophysiology Catheters: St. Jude Medica
Pending LLM rewrite. Source: FDA_DEVICE Z-1322-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
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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