Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Dragonfly OpStar Imaging Catheter Recalled by Abbott Vascular Due to There is a potential that the proximal marker...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Abbott Vascular directly.
Affected Products
Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.014 in, 135 cm, STERILE EO
Quantity: 14,544 UNITS
Why Was This Recalled?
There is a potential that the proximal marker may separate from the imaging catheter
Where Was This Sold?
This product was distributed to 43 states: AL, AZ, AR, CA, CO, CT, DE, FL, GA, HI, IL, IN, IA, KS, KY, ME, MD, MA, MI, MN, MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VT, VA, WA, WI, DC
About Abbott Vascular
Abbott Vascular has 37 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report