The Recall Desk
HighFDA (Devices)·Z-1852-2012·Announced 2012-06-27

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.

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: 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 three
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.

See all 3 products in this recall →