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

FDA device recall Z-1095-2022 · posted 2022-05-19 · Open, Classified

Recall details

Recalling firm

Abbott Vascular

Reason for recall

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

Action taken

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

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

DQO

Quantity affected

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,

Date initiated

2022-03-30

Date posted

2022-05-19

Location

Temecula, CA

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