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U.S. Department of Health and Human Services

Class 2 Device Recall ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM

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 Class 2 Device Recall ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEMsee related information
Date Initiated by FirmOctober 08, 2025
Date PostedNovember 20, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0573-2026
Recall Event ID 97803
510(K)NumberK043453 
Product Classification Reprocessed intravascular ultrasound catheter - Product Code OWQ
ProductBrand Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Product Name: CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Model/Catalog Number: ACU10135910 Software Version: N/A Product Description: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Component: N/A
Code Information Lot Code: GTIN/UDI: 10888551004725 LOT# SERIAL #: 2196112 999253 2200877 937157 2219499 1182771 2219926 1048031 2220881 1126584 2234882 2304200759
FEI Number 3011276773
Recalling Firm/
Manufacturer		 Sterilmed, Inc.
5010 Cheshire Pkwy N Ste 2
Plymouth MN 55446-4101
For Additional Information ContactMelissa Schultz
763-488-3400
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Reprocessing Controls
ActionInitial 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 in Commerce6
DistributionUnited States Only: Kentucky, Maryland, Massachusetts, Mississippi, New Jersey, Pennsylvania, Texas, Utah
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = OWQ
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