Recall Z-1851-2012— Boston Scientific Corporation

Name: FDA recall Z-1851-2012
Creator: U.S. Food and Drug Administration
Published: 2012-05-16

Class II · Terminated

Class II FDA medical device recall by Boston Scientific Corporation, initiated 2012-05-16, terminated 2013-02-28. It names one FDA 510(k) clearance: K941750. 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 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: Difficulty in extending snare loop from the catheter.

Recalling firm: Boston Scientific Corporation
Classification: Class II
Status: Terminated
Initiated: 2012-05-16
Terminated: 2013-02-28
Firm location: Marlborough, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K941750 — PROPOSED TRADEMAN MICROVASIVE POLYPECTOMY SNARESBoston Scientific Corp·cleared 1994-11-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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 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

Data sourced from openFDA. This site is unofficial and independent of the FDA.