Boston Scientific Recalls Pediatric Polypectomy Snares Due to Extension Difficulty
Boston Scientific is recalling 1,340 Profile Single-Use Pediatric Snares because the loop may be difficult to extend 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 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: The recall is classified as FDA Class II, and the hazard involves a functional defect in a medical device that could lead to adverse health consequences during a procedure, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Boston Scientific Corporation is recalling 1,340 units of the Profile Single-Use Pediatric Snare 27mm. The recall is due to a defect where the snare loop may be difficult to extend from the catheter. The affected product is identified by Lot Number 14974048, with Outer Box UPN M00562571 and Inner Pouch UPN M00562570.
The device is a single-use polypectomy snare consisting of a flexible wire cable loop that extends and retracts from a flexible outer sheath. It is designed to be passed through an endoscope to deliver monopolar electrical current for cutting and cauterizing tissue. The recall covers units distributed worldwide, including the United States, Canada, Australia, Austria, Belgium, France, Great Britain, Germany, Italy, the Netherlands, Qatar, Spain, Sweden, and Switzerland.
The FDA has classified this recall as Class II, which means the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. Users 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 27mm UPN Outer Box: M00562571 Inner Pouch: M00562570 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
- 1,340
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 (1)
- Lot Number: 14974048
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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