Reprocessed Inquiry Steerable Diagnostics Catheter for electrogram recording and cardiac stimulation
Pending LLM rewrite. Source: FDA_DEVICE Z-2612-2025.
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
Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection, and if particulate were to dislodge during use and contact circulating blood and/or the heart, it may produce a granulomatous reaction or thrombus formation, which may lead to cerebral or pulmonary embolism, or deep vein thrombosis.
The recalled product
- Product
- Reprocessed Inquiry Steerable Diagnostics Catheter for electrogram recording and cardiac stimulation during diagnostic electrophysiologic studies; Medline Item Numbers 81102RH 81104RH 81107RH 81174RH 81402RH 81404RH 81405RH 81472RH 81473RH 81474RH 81531RH 81532RH
- 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 (13)
- Item Number/UDI-DI 81102RH 10197344133239
- 81104RH 10197344133246
- 81107RH 10197344133260
- 81174RH 10197344133291
- 81402RH 10197344133352
- 81404RH 10197344133376
- 81405RH 10197344133383
- 81472RH 10197344133413
- 81473RH 10197344133420
- 81474RH 10197344133437
- 81531RH 10197344133512
- 81532RH 10197344133529
- LOTS EP250212 EP250214
Distribution
Distributed nationwide across the United States.
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