Boston Scientific Profile Single-Use Pediatric Snare 11mm UPN Outer Box M00562531 Inner Pouch: M00562530 , 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
FDA Recall Z-1850-2012 · Posted 2012-06-21
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Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeFDI
Date Initiated2012-05-16
Date Terminated2013-02-28
Product Quantity2760 units
Reason for Recall
Difficulty in extending snare loop from the catheter
Firm Action
Boston Scientific issued an Urgent Medical Device Recall Action letter via Federal Express Priority mail on May 16, 2012. The notification instructs the account to check their inventory, remove any affected product from their inventory, and return it to Boston Scientific. The notification also requests the completion of a Reply Verification Tracking Form. Scan and fax to 508-683-5578.
For questions regarding this recall call 508-683-8000.
Root Cause
Process control
Distribution Pattern
Worldwide Distribution - USA (nationwide) and the countries of Canada, Australia, Austria, Belgium, France, GB, Germany, Italy, Netherlands, Qatar, Spain, Sweden, and Switzerland
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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