The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1593-2023·Announced 2023-05-24

Watchdog Accessory Kit 20-Pack Recalled for Insertion Tool Occlusion

Boston Scientific's Watchdog Accessory Kit is being recalled because the insertion tool component can become occluded, preventing guidewire passage. The recall affects 10,833 units distributed worldwide.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II medical device recall with no reported illnesses or injuries. The insertion tool occlusion represents a risk-of-harm condition where the product cannot function as intended, but injury has not been reported, fitting the rubric criterion for High severity.

Plain-English summary

Boston Scientific Corporation is recalling the Watchdog Accessory Kit (20-pack) due to complaints of the insertion tool component becoming occluded. When the insertion tool is occluded, a guidewire cannot be passed through it, affecting the device's intended functionality.

Approximately 10,833 units have been distributed worldwide. The affected product units can be identified by batch numbers and product codes as referenced in the recall notice.

The recalled product

Product
WATCHDOG ACCESSORY KIT (20-PACK), UPN H74939343A021 (outer package), UPN H74939343A020 (inner package)
Manufacturer
Boston Scientific Corporation
Category
Medical Device — Interventional / Insertion Tools
Hazard
Affected units
10,833

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • GTIN 08714729965770 (outer package)
  • GTIN 08714729965794 (inner package)
  • Batch numbers: 30319836
  • 30359588
  • 30368418
  • 30392647
  • 30409465
  • 30421836
  • 30442123
  • 30522919
  • 30564343
  • 30577971
  • 30593836
  • 30600837
  • 30600839
  • 30601021
  • 30616553
  • 30620297
  • 30625219
  • 30638465

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 2 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Boston Scientific Corporation

See all →

Same hazard · device occlusion

See all →

Similar recalls