Mallinckrodt Inc 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Mallinckrodt Inc
Lot Codes / Batch Numbers
Catalog #V8400, Part No. 241078 & Catalog #V8402, Part #241079
Products Sold
Catalog #V8400, Part No. 241078 & Catalog #V8402, Part #241079
Mallinckrodt Inc is recalling The OptiVantage DH Injection System is a contrast delivery system and is designed to inject radiopaq due to 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 s. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NV, NJ, NM, NY, NC, OH, OR, PA, RI, SC, SD, TN, TX, VA, WA, WV, WI, DC
Page updated: Jan 10, 2026