—#199581

Product

WATCHDOG Hemostasis Valve Kit, UPN H74939343A022 (outer package), UPN H74939343A020 (inner package)

FDA product code: DTL — Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K172453
Affected lot / code info: GTIN 08714729996019 (outer package), GTIN 08714729965794 (inner package), Batch numbers: 30272850,30542947,30661041,30845826, 30935565

Why it was recalled

The firm received complaints of the Insertion Tool component being occluded, resulting in the inability to pass a guidewire through the tool.

Root cause (FDA determination)

Process control

Action the firm took

Boston Scientific issued an URGENT MEDICAL DEVICE PRODUCT REMOVAL notice on 04/05/2023 by overnight mail. The notice explained the issue and the hazard and requested the consignee segregate the devices pending return. Medical facilities who distributed the devices and distributors were directed to send the notice to their customers.

Recalling firm

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

Distribution

Distribution pattern: Worldwide

Timeline

Recall initiated: 2023-04-05
Posted by FDA: 2023-05-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #199581. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.