Avanta Fluid Management Injection System, Avanta… recallZ-1199-2010 · Medrad Inc · initiated Jan 6, 2010
Terminated All recalls posted in March 2010
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medrad Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The product may be defective resulting in a reduction of the saline delivery rate and inadequate air purging.
FDA root cause category: Nonconforming Material/Component
What the company is doing
The recalling firm issued an Urgent Medical Device Recall letter dated 1/6/10 to all customers that received the affected lots. The customers were instructed to determine whether or not they had the affected product lots. Customers are to discontinue use and contact MEDRAD Customer Support or their MIP Rep to make arrangements for return of the recalled product. Any affected product returned will be replaced at no charge to the customer. Customers are also to complete and sign the attached form and fax it back to the firm. Questions concerning this recall are to be directed to Deb Easler, Product Manager, at 412-767-2400.
Recall details
- Recall number
- Z-1199-2010
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jan 6, 2010
- Posted by the FDA
- Mar 23, 2010
- Recalling firm
- Medrad Inc
- Quantity
- 2625 pieces
- Product code
- DXT
- FDA submissions
- K050456
- Distribution
- Worldwide Distribution -- USA, including stated of AL, AZ, CA, DC, FL, GA, IL, KS, MD, MO, NM, NY, OH,OK, PA, TN, TX, and WI. and countries of Belgium, Germany, and Italy.
Product description
Avanta Fluid Management Injection System, Avanta Multi-Patient Disposable Set (MPAT) High Pressure Check Valve, Catalog number AVA 500 MPAT, Material number 3018231.
Code information (models, lots, serial numbers)
Lot numbers 820007 and 820008
Other devices under the same FDA submission
3 devices cleared under K050456 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- MEDRAD® Avanta Fluid Management Injection SystemBayer Medical Care Inc. · Injector And Syringe, Angiographic1 death5 reports
- MEDRAD® Avanta Fluid Management Injection SystemBayer Medical Care Inc. · Injector And Syringe, Angiographic1 death3 reports
- MEDRAD® Avanta Single Patient Disposable Set – Transducer Compatible AVA 500 SPAT LBayer Medical Care Inc. · Injector And Syringe, Angiographic1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page