Dragonfly OpStar Imaging Catheter — Class I medical device recall Z-1095-2022
Ongoing recall by Abbott Vascular, reported 2022-05-25, distributed in AL, AR, AZ, CA, CO, CT, DC, FL…. There is a potential that the proximal marker may separate from the imaging catheter
| Recall number | Z-1095-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Vascular, Temecula, CA, United States |
| Recall initiated | 2022-03-30 |
| Classified | 2022-05-19 |
| Reported by FDA | 2022-05-25 |
| Distributed | 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 |
| Quantity | 14,544 units |
| UPC / GTIN / UDI-DI | 05415067031112, 05415067031129 |
| Lot numbers | 8010027, 8010043, 8010047, 8010052, 8111644, 8127930, 8127931, 8127932, 8127934, 8131360, 8131361, 8131362, 8131363, 8131364, 8131365, 8131366, 8131367, 8131369, 8131370, 8147186, 8147188, 8147191, 8153815, 8153816, 8157505, 8157506, 8184979, 8184980, 8184981, 8184982, 8185100, 8185101, 8192782, 8192783, 8192784, 8192786, 8192787, 8192788, 8192789, 8192791 and 38 more |
| Model numbers | 0.014, 0.068, 1014651, 1014651/1014652, 1014652, 135 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1095-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.