Recall archive / FDA device enforcement
Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.014 in, 135 cm, STERILE EO — FDA record Z-1095-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Mar 30, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.014 in, 135 cm, STERILE EO
- Reason
- There is a potential that the proximal marker may separate from the imaging catheter
- Classification
- Class I
- Recalling firm
- Abbott Vascular
- Quantity
- 14,544 UNITS
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1095-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
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
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Illinois
- Kansas
- Kentucky
- Massachusetts
- Maryland
- Michigan
- Minnesota
- Missouri
- Montana
- North Carolina
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Pennsylvania
- Rhode Island
- South Carolina
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
Dates in the source
- Report date
- May 25, 2022
- Recall initiation date
- Mar 30, 2022
- Center classification date
- May 19, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.