Reprocessed electrophysiology catheters recalled over residual material particles
Medline is recalling 48 reprocessed St. Jude Supreme and Response diagnostic electrophysiology catheters because these lots may contain small particles of residual material.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: Scored 5 because the FDA has classified this action as Class I, which the rubric maps directly to Critical.
Plain-English summary
Reprocessed St. Jude Supreme and Response Diagnostic Electrophysiology Catheters are being recalled by Medline Industries, LP. The record lists the affected catalog numbers, beginning 401211RH, 401222RH, 401223RH, 401226RH and 401227RH, with the full list set out in the enforcement record.
The record states these lots of reprocessed catheters may contain small particles of residual material. It states that 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. The record notes this is an expansion of recall Z-2610/2614-2025.
The record lists 48 units, with UDI-DI codes and lot numbers recorded in the enforcement record. Distribution was nationwide in the United States. The FDA has classified the action as Class I, its most serious category.
Facilities should quarantine affected stock and follow Medline's instructions.
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…
- Manufacturer
- Medline Industries, LP
- Affected units
- 48
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.
Part of a larger recall action
This product is one of 7 recalled by Medline Industries, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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