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.
What this means for you
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
- 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.
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