WATCHDOG recallZ-1592-2023 · Boston Scientific Corporation · initiated Apr 5, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Boston Scientific Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-1592-2023
- Status
- Open, Classified
- Initiated by the company
- Apr 5, 2023
- Posted by the FDA
- May 16, 2023
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 1300 units
- Product code
- DTL
- FDA submissions
- K172453
- Distribution
- Worldwide
Product description
WATCHDOG Hemostasis Valve Kit, UPN H74939343A022 (outer package), UPN H74939343A020 (inner package)
Code information (models, lots, serial numbers)
GTIN 08714729996019 (outer package), GTIN 08714729965794 (inner package), Batch numbers: 30272850,30542947,30661041,30845826, 30935565
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- WATCHDOG™ H74939343A020Boston Scientific Corporation · Wire, guide, catheter2 recalls2 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 92072).
- Z-1593-2023 · Open, ClassifiedWATCHDOG ACCESSORY KIT (20-PACK), UPN H74939343A021 (outer package), UPN H74939343A020 (inner package)
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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