Z-1896-2009

Boston Scientific Clipping Device, Resolution Clip, working length 235 cm, working channel 2.8 mm...

Name: Z-1896-2009 Boston Scientific Clipping Device, Resolution Clip, working length 235 cm, working channel 2.8 mm...
Creator: Boston Scientific Corporation
Published: 2009-06-17
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2009-06-17 / Terminated / root cause: manufacturing process

FDA source

Boston Scientific Corporation began a recall of Boston Scientific Clipping Device, Resolution Clip, working length 235 cm, working channel 2.8 mm, Manufactured for Boston Scientific Corporation, Natick, MA... on 2009-06-17. The reason FDA records is "The clip may not deploy or, if deployed, the clip may not release from the tissue". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1896-2009
Status: Terminated
Initiated: 2009-06-17
Posted: 2009-09-02
Terminated: 2010-10-08
Recalling firm: Boston Scientific Corporation
Product: Boston Scientific Clipping Device, Resolution Clip, working length 235 cm, working channel 2.8 mm, Manufactured for Boston Scientific Corporation, Natick, MA; Product codes M00522610 (1 clip) and M00522612 (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.
Product code: FHN Ligator, Hemorrhoidal
Reason for recall: The clip may not deploy or, if deployed, the clip may not release from the tissue.
Root cause tag: manufacturing process
FDA root cause: Process control
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.
Quantity in commerce: 4269
Distribution: Nationwide, France, Germany, Great Britain, Italy, Netherlands, Spain and Sweden.
Product codes and lots: Product code M00522610, lots 0ML9042004, 0ML9042101, 0ML9042102, 0ML9042702, 0ML9050401 and 0ML9051201. Product code M00522612, lots 0ML9042005, 0ML9042006, 0ML9042204, 0ML9042705, 0ML9042706, 0ML9050402, 0ML9050403, 0ML9051205 and 0ML9051206.

Product code FHN

K040148Class IIResolution Hemostasis Clipping DeviceBoston Scientific Corp / cleared 2004-04-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)