WATCHDOG Hemostasis Valve Kit recalled for insertion tool occlusion
Boston Scientific recalls 1,300 WATCHDOG Hemostasis Valve Kits due to insertion tool occlusion that prevents guidewire passage. Affected units were 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 FDA Class II recall involves a medical device with a functional defect that prevents proper use. No reported injuries or illnesses. It qualifies as a risk-of-harm product with unreported injury, meeting the High severity criterion.
Plain-English summary
Boston Scientific Corporation is recalling 1,300 units of the WATCHDOG Hemostasis Valve Kit due to complaints of a defect in the insertion tool component. The recalled units are identified by outer package UPN H74939343A022, inner package UPN H74939343A020, and batch numbers 30272850, 30542947, 30661041, 30845826, and 30935565.
The insertion tool component has been reported to become occluded, resulting in the inability to pass a guidewire through the tool. This defect was documented in complaints received by Boston Scientific Corporation.
The affected kits were distributed worldwide to healthcare providers and medical facilities.
The recalled product
- Product
- WATCHDOG Hemostasis Valve Kit, UPN H74939343A022 (outer package), UPN H74939343A020 (inner package)
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 1,300
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 (7)
- GTIN 08714729996019 (outer package)
- GTIN 08714729965794 (inner package)
- Batch numbers: 30272850
- 30542947
- 30661041
- 30845826
- 30935565
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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