Z-1095-2022Class I

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

Name: Z-1095-2022 Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.014 in, 135 cm, STERILE EO
Creator: Abbott Vascular
Published: 2022-03-30
License: https://open.fda.gov/license/

Abbott Vascular / initiated 2022-03-30 / Open, Classified

FDA source

Abbott Vascular began a recall of Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.014 in, 135 cm, STERILE EO on 2022-03-30. FDA classified it as Class I and gives the reason as "There is a potential that the proximal marker may separate from the imaging catheter". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1095-2022
Classification: Class I
Status: Open, Classified
Initiated: 2022-03-30
Posted: 2022-05-19
Recalling firm: Abbott Vascular
Product: Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.014 in, 135 cm, STERILE EO
Product code: DQO Catheter, Intravascular, Diagnostic
Reason for recall: There is a potential that the proximal marker may separate from the imaging catheter
FDA 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 relevant personnel in your organization. 6If you have further distributed/transferred the affected products, notify those customers. 7. Report any occurrence of product performance issues or patient adverse event to Abbott. 8. Reports may also be sent to the FDA's MedWatch Adverse Event Reporting program by completing Form FDA 3500 online at www.fda.gov or calling 1-800-FDA-1088 or submit by mail or fax to 1-800-FDA-0178
Quantity in commerce: 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
Product codes and lots: Model 1014651 - GTIN: (01)05415067031129 Lot #: 8010027 8147191 8010043 8153815 8010047 8153816 8010052 8211505 8127930, 8211506, 8127931, 8211507, 8127932, 8220671, 8127934, 8220672, 8131366, 8220673, 8131367, 8220675, 8131369, 8257085, 8131370, 8257087, 8147186, 8274128 8147188, 8294077 Model 1014652 - GTIN: (01) 05415067031112 Lot #:8111644, 8192796, 8131360, 8211508, 8131361, 8211509, 8131362, 8211510,8131363 8211511, 8131364, 8211512, 8131365, 8211513, 8157505, 8211514, 8157506, 8211515 8184979, 8211516, 8184980, 8211517, 8184981, 8211518, 8184982, 8211519, 8185100 8211520, 8185101, 8211521, 8192782, 8220680, 8192783, 8220681, 8192784, 8220684, 8192786, 8220685, 8192787, 8220686, 8192788, 8256952, 8192789, 8256953, 8192791 8256954, 8192793, 8274133, 8192795, 8294003

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1095-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1095-2022	Class I	Ongoing	Voluntary: Firm initiated	2022-05-25	2022-05-19

Product code DQO

K192019Class IIDragonfly OpStar™ Imaging Catheter, AptiVue™ Software version E.5.1Abbott Medical / cleared 2019-11-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)