Boston Scientific Clipping Device, Resolution Clip, working length 155 cm, working channel 2.8 mm, Manufactured for Boston Scientific Corporation, Natick, MA; Product codes M00522600 (1 clip) and M00522602 (20 clips). The Resolution Clip Device is a pre-loaded single-use clip on a flexible delivery system. It is placed into the gastrointestinal tract for the purpose of endoscopic marking, hemostasis, anchoring jejunal tubes and closure of lumenal perforations.
FDA Recall Z-1895-2009 · Posted 2009-09-02
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Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeFHN
Date Initiated2009-06-17
Date Terminated2010-10-08
Product Quantity217
Reason for Recall
The clip may not deploy or, if deployed, the clip may not release from the tissue.
Firm Action
Consignees were notified by an "Urgent Recall Letter " dated June 17, 2009 and instructed to cease using the product because the calibration of equipment used to manufacture these products was not in control. This may potentially result in an inability to deploy or release the clip from the catheter. Consignees were instructed to return a business reply form for return authorization. Please contact Cindy Finney, Field Action Team Lead at 1-508-683-4678 for assistance.
Root Cause
Process control
Distribution Pattern
Nationwide, France, Germany, Great Britain, Italy, Netherlands, Spain and Sweden.
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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