PlainRecalls
FDA Devices Moderate Class II Terminated

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-ring handle. When passed through an endoscope and activated, the snare delivers a monopolar electrical current to cut and cauterize tissue with the loop

Reported: June 27, 2012 Initiated: May 16, 2012 #Z-1852-2012

Product Description

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-ring handle. When passed through an endoscope and activated, the snare delivers a monopolar electrical current to cut and cauterize tissue with the loop

Reason for Recall

Difficulty in extending snare loop from the catheter

Details

Units Affected
1340 units
Distribution
Worldwide Distribution - USA (nationwide) and the countries of Canada, Australia, Austria, Belgium, France, GB, Germany, Italy, Netherlands, Qatar, Spain, Sweden, and Switzerland
Location
Marlborough, MA

Frequently Asked Questions

What product was recalled?
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-ring handle. When passed through an endoscope and activated, the snare delivers a monopolar electrical current to cut and cauterize tissue with the loop. Recalled by Boston Scientific Corporation. Units affected: 1340 units.
Why was this product recalled?
Difficulty in extending snare loop from the catheter
Which agency issued this recall?
This recall was issued by the FDA Devices on June 27, 2012. Severity: Moderate. Recall number: Z-1852-2012.