Z-1694-2008

The OptiVantage DH Injection System is a contrast delivery system and is designed to inject radiopaque...

Name: Z-1694-2008 The OptiVantage DH Injection System is a contrast delivery system and is designed to inject radiopaque...
Creator: Mallinckrodt Inc
Published: 2008-04-07
License: https://open.fda.gov/license/

Mallinckrodt, Inc. / initiated 2008-04-07 / Terminated / root cause: design

FDA source

Mallinckrodt Inc began a recall of 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... on 2008-04-07. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1694-2008
Status: Terminated
Initiated: 2008-04-07
Posted: 2008-08-15
Terminated: 2011-05-20
Recalling firm: Mallinckrodt, Inc.
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.
Product code: IZQ Injector, Contrast Medium, Automatic
Reason for recall: 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.
Root cause tag: design
FDA root cause: Component design/selection
Action: 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.
Quantity in commerce: 783 Units
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 codes and lots: Catalog #V8400, Part No. 241078 & Catalog #V8402, Part #241079

Product code IZQ

K063503Class IIOptivantage Dh Injector System with Enhanced CommunicationMallinckrodt Inc., Liebel-Flarsheim Business / cleared 2007-04-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)