Recall Z-1095-2022 · DQO Catheter, Intravascular, Diagnostic
Abbott Vascular
Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.014 in, 135 cm, STERILE EO
| Date | May 19, 2022 (initiated Mar 30, 2022) |
| Status | Open, Classified |
| Reason | There is a potential that the proximal marker may separate from the imaging catheter |
| Root cause | Under Investigation by firm |
| Action | On April 11, 2022, Abbott issued a "Urgent: Medical Device Recall" Notification to all affected consignees. On June 6, 2022, Abbott issued a updated Urgent Medical Device Recall notification to provide new information concerning the recall product. Abbott ask consignees to take the following actions: 1. Immediately stop using devices from affected lots 2. Return all unused affected devices to Abbott (if not already completed per previous communication) 3. Review this updated notification letter 4. Complete and return the provided Effectiveness Check Form 5 Share this notification with rele |
| Quantity | 14,544 UNITS |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K192019 | Dragonfly OpStar Imaging Catheter, AptiVue Software version E.5.1 ABBOTT MEDICAL, Nov 8, 2019 |