Reprocessed Electrophysiology Catheters Recalled for Residual Particulate Risk
Medline is recalling over 7,900 reprocessed electrophysiology catheters due to potential residual particulates on patient-contacting surfaces that could cause infection or blood clots.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This recall is classified as Severe due to its FDA Class I designation, which establishes a minimum severity threshold of 4. The absence of reported deaths or illnesses prevents classification as Critical (5).
Plain-English summary
Medline Industries, LP is recalling reprocessed Inquiry Steerable Diagnostics Catheters used for electrogram recording and cardiac stimulation during diagnostic electrophysiologic studies. The recall affects approximately 7,913 units from lots EP250212 and EP250214, with item numbers 81102RH, 81104RH, 81107RH, 81174RH, 81402RH, 81404RH, 81405RH, 81472RH, 81473RH, 81474RH, 81531RH, and 81532RH.
The recalled catheters may contain small residual particulates on patient-contacting surfaces. If used, these devices pose a potential risk of inflammatory response or systemic infection. If particulates dislodge during use and contact circulating blood or the heart, they may produce a blood clot (thrombus) or trigger a granulomatous reaction, potentially leading to cerebral embolism, pulmonary embolism, or deep vein thrombosis—serious, life-threatening complications.
The affected catheters were distributed domestically throughout the United States. Patients and healthcare providers currently using these devices should discontinue use immediately and contact Medline Industries, LP for replacement devices or further instructions.
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
- Hazard
- residual-particulates
- infection
- thrombus
- embolism
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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