FDA recall Z-1095-2022

Product

Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.014 in, 135 cm, STERILE EO

Reason for recall

There is a potential that the proximal marker may separate from the imaging catheter

Distribution

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

Key facts

Status

Ongoing

Initiation date

2022-03-30

Report date

2022-05-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Temecula, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1095-2022