FDA-Device2022-05-25Class I
Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.014 in, 135 cm, STERILE EO
Abbott Vascular
Hazard
There is a potential that the proximal marker may separate from the imaging catheter
Sold states
US:AL AR AZ CA CO CT DC FL GA HI IA IL IN KS KY MA MD ME MI MN MO MT NC NE NH NJ NM NV NY OH OK OR PA PR RI SC TN TX UT VA VT WA WI, PR OUS: AE, AT, AW, BE, CA, CH, DE, DK, IT, JP, LU, NL, NO, NZ, PL, EE, ES, FI, FR, GB, HK, HU, IE, PT, RO, SE, SG, SI, TH
Affected count
14,544 UNITS
Manufactured in
26531 Ynez Rd, N/A, Temecula, CA, United States
Products
Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.014 in, 135 cm, STERILE EO
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1095-2022Don't want to check this manually?
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