—#206674

Product

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL1 (5PK), REF H74908526962; cardiac catheter

FDA product code: DQO — Catheter, Intravascular, Diagnostic
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K152605
Affected lot / code info: UDI/DI 08714729187936, Batch Numbers: 60438199, 60453733, 60472577, 60486300, 60500754, 60513563, 60438660, 60459203, 60473158, 60491662, 60507655, 60529457, 60440956, 60465786, 60477280, 60495526, 60507656, 60533641, 60445923, 60465788, 60477281, 60495527, 60511179, 60538216, 60448986, 60467041, 60477282, 60498225, 60511181, 60538217, 60449233, 60467087, 60486299, 60498226, 60512377

Why it was recalled

An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Boston Scientific issued an Urgent Medical Device Removal notice to its consignees on 03/21/2024 via overnight delivery. The notice explained the issue, the potential risk, and requested the removal of the affected products. Distributors were directed to notify their consignees.

Recalling firm

Firm: Boston Scientific Corporation
Address: 1 Scimed Pl, Maple Grove, Minnesota 55311-1565

Distribution

Distribution pattern: Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.

Timeline

Recall initiated: 2024-03-21
Posted by FDA: 2024-05-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #206674. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.