HIGH

Medline Recalled 7,913 Reprocessed ACUSON AcuNav Ultrasound Catheters for Intracardiac Imaging

Medline Industries recalled 7,913 reprocessed ACUSON AcuNav ultrasound catheters nationwide in the United States. The recall cites residual particulates on patient-contacting surfaces as the hazard. Consumers should stop use and follow manufacturer instructions for recall actions.

Quick Facts at a Glance

Recall Date
July 31, 2025
Hazard Level
HIGH
Brand
Medline Industries, LP
Category
Health & Personal Care
Sold At
Unknown
Geographic Scope
1 states
At-Risk Groups
GENERAL, PREGNANT, INFANTS

Hazard Information

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.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Medline Industries, LP or your healthcare provider for instructions. Notification method: Letter

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About This Product

Reprocessed ACUSON AcuNav ultrasound catheters are used for intracardiac and great vessel visualization during interventional procedures. They provide imaging guidance.

Why This Is Dangerous

Residual particulates on patient-contacting surfaces may trigger inflammatory responses or infections. Particulates could dislodge and cause emboli.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

High risk to patients during procedures; immediate stop-use required; potential for serious embolic events and infection.

Practical Guidance

How to identify if yours is affected

  1. Check the device lot numbers EP241021, EP241114, EP241226, EP250213, EP240731, EP240814, EP240826, EP240903, EP240916, EP241003, EP241014, EP241028, EP241104, EP241112, EP241202, EP241209A, EP241219, EP241224, EP250114, EP250116, EP250204, EP250219 on the device or documentation.
  2. Confirm GE or Siemens compatibility per model numbers 10135910RH and 10135936RH.
  3. Verify item numbers 10135910RH and 10135936RH.

Where to find product info

FDA recall page Z-2614-2025 and Medline communications.

What timeline to expect

Recall notifications will specify steps for replacement or refund; processing times vary by manufacturer.

If the manufacturer is unresponsive

  • Document all communications with Medline and healthcare providers.
  • Escalate to FDA through MedWatch if necessary.

How to prevent similar issues

  • Enhance supplier lot-traceability for reprocessed devices.
  • Verify cleanliness and absence of particulates in reprocessed catheters before use in future purchases.

Documentation advice

Keep all recall notices, lot numbers, and healthcare communications as part of medical device incident records.

Product Details

Brand: Medline Industries, LP. Product: Reprocessed ACUSON AcuNav Ultrasound Catheter for intracardiac and intra-luminal visualization. Item numbers referencing use with GE and Siemens systems. Lots EP241021, EP241114, EP241226, EP250213; EP240731, EP240814, EP240826, EP240903, EP240916, EP241003, EP241014, EP241028, EP241104, EP241112, EP241202, EP241209A, EP241219, EP241224, EP250114, EP250116, EP250204, EP250219. Quantity: 7913 eaches. Distribution: Domestic US nationwide. International distribution pending, none reported.

Reported Incidents

No explicit incident counts provided in the notice. The FDA enforcement report indicates a Class I recall with high hazard level.

Key Facts

  • 7,913 units recalled
  • Lots EP241021, EP241114, EP241226, EP250213, EP240731, EP240814, EP240826, EP240903, EP240916, EP241
  • For GE and Siemens systems compatibility: 10135910RH 10197344026500; 10135936RH 10197344026517
  • Active status as of 2025-10-08
  • Distribution within the United States; international distribution pending
View Original Recall on FDA - Medical Devices

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Safety Assessment

Risk LevelHIGH
Severity Score
9/ 10
Affected Groups
GENERALPREGNANTINFANTSELDERLYPETS
Injury Types
ELECTRICALLACERATIONPOISONINGFALLSUFFOCATIONCRUSHINGOTHERBURN

Product Classification

Product TypeUltrasound Catheter
Sold At
Unknown

Product Details

Model Numbers
10135910RH (for GE Systems) 10197344026500
10135936RH (for Siemens Systems) 10197344026517
LOTS EP241021 EP241114 EP241226 EP250213 EP240731 EP240814 EP240826 EP240903 EP240916 EP241003 EP241014 EP241028 EP241104 EP241112 EP241202 EP241209A EP241219 EP241224 EP250114 EP250116 EP250204 EP250219
Affected States
ALL
Report Date
October 8, 2025
Recall Status
ACTIVE

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