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

Is my product affected?

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

• UPC 05415067031129
• UPC 05415067031112

Check against the official notice below — it lists the full affected range.

What happened

Abbott Vascular is recalling 14,544 units of Dragonfly OpStar Imaging Catheter (models 1014651 and 1014652) because the proximal marker may separate from the imaging catheter. The affected catheters were distributed in the United States, Puerto Rico, and multiple other countries including Canada, Japan, the United Kingdom, and various European nations. The recall involves specific lot numbers for each model.

The recall record does not specify a remedy for consumers who have this product.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

There is a potential that the proximal marker may separate from the imaging catheter

Details from the source

Reason for recall: There is a potential that the proximal marker may separate from the imaging catheter 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 Quantity: 14,544 UNITS Lot/code info: 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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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