Dragonfly OpStar Imaging Catheter recall
Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.014 in, 135 cm, STERILE EO
Why was Dragonfly OpStar Imaging Catheter recalled?
There is a potential that the proximal marker may separate from the imaging catheter
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.014 in, 135 cm, STERILE EO
- Recalling firm
- Abbott Vascular
- 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
- Recall date
- May 25, 2022
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)