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Open, Classified

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

FDA Recall Z-1592-2023 · Posted 2023-05-16

Recalling FirmBoston Scientific Corporation
Recall StatusOpen, Classified
Product CodeDTL
Date Initiated2023-04-05
Product Quantity1300 units

Reason for Recall

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

Firm Action

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.

Root Cause

Process control

Distribution Pattern

Worldwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K172453WATCHDOG Hemostasis Valve KitBoston Scientific Corporation · 2017-11-09

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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