Recall Z-0574-2026 ยท OWQ Reprocessed Intravascular Ultrasound Catheter
Sterilmed, Inc.
Brand Name: Sterilmed Reprocessed Imaging Catheter Product Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR FOR USE WITH SIEMENS SYSTEM Model/Catalog Number: ACU10135936 Software Version: N/A Product Description: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR FOR USE WITH SIEMENS SYSTEM Component: N/A
| Date | Nov 20, 2025 (initiated Oct 8, 2025) |
| Status | Open, Classified |
| Reason | Affected catheters were reprocessed beyond validated cycles. This may compromise device sterility or mechanical integrity of the device and can lead to severe adverse events such as infection, vascular injury or embolism. |
| Root cause | Reprocessing Controls |
| Action | Initial phone call notification was performed 10/10/2025 to affected customers. Customers were instructed to immediately stop use of identified devices. Affected products should be segregated. Follow-up written notification was sent to customers on 10/17/25 which included instructions on how to return affected products. |
| Quantity | 4 |
| Distribution | United States Only: Kentucky, Maryland, Massachusetts, Mississippi, New Jersey, Pennsylvania, Texas, Utah |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043453 | STERILEMED REPROCESSED IVUS IMAGING CATHETER Sterilmed, Inc., Mar 1, 2005 |