The OptiVantage DH Injection System is a contrast delivery… recallZ-1694-2008 · Mallinckrodt Inc · initiated Apr 7, 2008
Terminated All recalls posted in August 2008
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 Mallinckrodt 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
Screws can begin to loosen and shear off to the point of the J-Bow falling from the suspension system. This may cause injury to patients or hospital staff.
FDA root cause category: Component design/selection
What the company is doing
On April 18, 2008, Mallincrodt Inc. issued an Urgent Device Correction letter informing customers to check their inventory, and determine if they have any defective system units. If they observe any loose screws, sheared screws and/or elongated opening(s) around the screws, they are to immediately take the system out of service and contact the firm's service representative. Covidien's customers were all asked to inspect their inventories and to complete an 'Effectiveness Check Return Form' whether or not the product is defective. However, only those system units observed to have loose screws, sheared screws, and/or elongated openings around the screws, will be scheduled to receive correction by a Covidien Service Representative.
Recall details
- Recall number
- Z-1694-2008
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Apr 7, 2008
- Posted by the FDA
- Aug 15, 2008
- Recalling firm
- Mallinckrodt Inc
- Quantity
- 783 Units
- Product code
- IZQ
- FDA submissions
- K063503
- Distribution
- Product is distributed in the US throughout the following states: AL, AR, AZ, CA, CO ,CT, DC, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI, and WV.
Product description
The OptiVantage DH Injection System is a contrast delivery system and is designed to inject radiopaque contrast media into a patient's vascular system to obtain diagnostic images when used with computed tomography equipment. The J-Bow component is used to connect the powerhead to a suspension system.
Code information (models, lots, serial numbers)
Catalog #V8400, Part No. 241078 & Catalog #V8402, Part #241079
Other devices under the same FDA submission
2 devices cleared under K063503 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
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.
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