Class 1 Device Recall Dragonfly Opstar Imaging Catheter

• Date Initiated by Firm: March 30, 2022
• Date Posted: May 19, 2022
• Recall Status: Open, Classified
• Recall Number: Z-1095-2022
• Recall Event ID: 90002
• 510(K)Number: K192019
• Product Classification: Catheter, intravascular, diagnostic - Product Code DQO
• Product: Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.014 in, 135 cm, STERILE EO
• Code Information: 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
• Recalling Firm/ Manufacturer: Abbott Vascular; 26531 Ynez Rd; Temecula CA 92591-4630
• For Additional Information Contact: Alicia Swanson; 224-845-3427
• Manufacturer Reason for Recall: There is a potential that the proximal marker may separate from the imaging catheter
• FDA Determined 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = DQO and Original Applicant = Abbott Medical