Reprocessed cardiac ultrasound catheters recalled due to residual particulates
Medline is recalling reprocessed ACUSON AcuNav ultrasound catheters that may have residual particulates, creating risk of infection, blood clots, or embolism.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: FDA designated this as a Class I recall, which is explicitly listed in the severity rubric as a criterion for Critical severity score.
Plain-English summary
Medline Industries is recalling 7,913 reprocessed ACUSON AcuNav ultrasound catheters distributed nationwide in the United States. These catheters are used to guide imaging during cardiac procedures. Certain lots may contain small residual particles on the surfaces that contact patients.
If present, these particles pose risks of inflammatory response or infection. If particles dislodge during use and contact the patient's blood or heart, they may form blood clots or trigger serious inflammatory reactions. Potential complications include blood clots in the lungs or brain, or deep vein thrombosis.
Healthcare facilities using these catheters should verify their inventory against the affected lot numbers and discontinue use of recalled units. Patients who have undergone procedures with these catheters should contact their healthcare provider if they develop symptoms such as chest pain, shortness of breath, or leg swelling.
Medialine Industries can provide information on device retrieval or replacement options.
The recalled product
- Product
- Reprocessed ACUSON AcuNav Ultrasound Catheter for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. For imaging guidance only, not treatment delivery, during cardiac interventio
- Manufacturer
- Medline Industries, LP
- Hazard
- residual-particulates
- thrombosis
- embolism
- infection
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 (2)
- Item Number/UDI-DI 10135910RH (for use on GE Systems) 10197344026500
- 10135936RH (For use on Siemens Systems) 10197344026517
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- HighGE CARESCAPE Telemetry Server may lose patient ECG and oxygen saturation monitoring
FDA (Devices) · 2026-06-03
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- HighPhilips Azurion and Allura Imaging Systems Recalled for Hard Drive Degradation
FDA (Devices) · 2026-06-03