FDA Medical Device Recalls (openFDA)
Medline Industries, LP: 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
- Recall number
- Z-2612-2025
- Recalling firm
- Medline Industries, LP
- 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
- Status
- Open, Classified
- Initiated
- 2025-07-31
- Posted
- 2025-09-26
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Under Investigation by firm
- Action
- On July 31, 2025, the firm notified customers via first class mail and email of the potential product issue. An updated letter was sent to customers on 8/13/25 with additional item and lot numbers. Affected products are to be returned for credit. Customers were instructed to immediately identify and quarantine all affected product within their possession. Once they have completed and returned the response form listing their affected inventory, they will receive return labels and RGA information. Customers will receive credit when the returned product is received.
- Quantity
- 7913 eaches
- Distribution
- Domestic US distribution nationwide. International distribution pending. No international distribution.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K242225"]
- PMA numbers
- not on file
- Product code
- NLH
- Firm FEI
- 1417592
- Firm city
- Northfield
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28