The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1851-2012·Announced 2012-06-27

Boston Scientific Pediatric Snare Recalled for Extension Difficulty

Boston Scientific is recalling 1,970 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 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 recall involving a functional defect without reported harm.

Plain-English summary

Boston Scientific Corporation is recalling 1,970 units of the Profile Single-Use Pediatric Snare 13mm. The recall is due to a defect where the snare loop may be difficult to extend from the catheter. The affected product consists of a flexible wire cable loop that is used to cut and cauterize tissue during endoscopic procedures.

The affected lots are 14951482, 14951484, and 15068143. The product was distributed worldwide, including the United States, Canada, Australia, Austria, Belgium, France, Great Britain, Germany, Italy, the Netherlands, Qatar, Spain, Sweden, and Switzerland. The outer box product number is M00562551 and the inner pouch product number is M00562550.

Healthcare providers should stop using the affected devices and contact Boston Scientific for instructions on how to return or dispose of the product. Patients who have had procedures using these devices should contact their healthcare provider if they have concerns.

The recalled product

Product
Boston Scientific Profile Single-Use Pediatric Snare 13mm UPN Outer Box: M00562551 Inner Pouch: M00562550 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
Category
Medical Device — Endoscopic Instruments
Hazard
Affected units
1,970

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 (3)

  • Lot Numbers: 14951482
  • 14951484
  • 15068143

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 →

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