Boston Scientific Pediatric Snare Recalled for Extension Difficulty
Boston Scientific is recalling Profile Single-Use Pediatric Snares due to difficulty extending the snare loop from the catheter.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity score.
Plain-English summary
Boston Scientific Corporation is recalling 2,760 units of the Profile Single-Use Pediatric Snare 11mm. The recall involves specific lot numbers: 14951476, 14951479, 14987882, and 15068203. The product is identified by Outer Box M00562531 and Inner Pouch M00562530.
The reason for the recall is difficulty in extending the snare loop from the catheter. The device is a single-use polypectomy snare consisting of a flexible wire cable loop that extends and retracts from a flexible outer sheath using a three-ring handle. It is designed to deliver monopolar electrical current to cut and cauterize tissue when passed through an endoscope.
The affected units were distributed worldwide, including the United States (nationwide), Canada, Australia, Austria, Belgium, France, Great Britain, Germany, Italy, the Netherlands, Qatar, Spain, Sweden, and Switzerland. Healthcare providers and facilities should stop using the affected devices and contact Boston Scientific for instructions on return or replacement.
The recalled product
- Product
- Boston Scientific Profile Single-Use Pediatric Snare 11mm UPN Outer Box M00562531 Inner Pouch: M00562530 , The single-use Profile Polypectomy Snare consists of a flexible wire cable loop which can be extended and retracted from the snare's flexible outer sheath using a…
- Manufacturer
- Boston Scientific Corporation
- Hazard
- Affected units
- 2,760
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 (4)
- Lot Numbers: 14951476
- 14951479
- 14987882
- 15068203
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 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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