Z-3056-2011

The Resolution II Clip, 155 cm size and 235 cm size, Boxes of 1, 10, and 20 clips consists of a pre-loaded...

Name: Z-3056-2011 The Resolution II Clip, 155 cm size and 235 cm size, Boxes of 1, 10, and 20 clips consists of a pre-loaded...
Creator: Boston Scientific Corporation
Published: 2011-07-19
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2011-07-19 / Terminated

FDA source

Boston Scientific Corporation began a recall of The Resolution II Clip, 155 cm size and 235 cm size, Boxes of 1, 10, and 20 clips consists of a pre-loaded, radiopaque single use clip on a flexible delivery... on 2011-07-19. The reason FDA records is "Boston Scientific has received reports where, following clip deployment, the alignment of the clip and delivery system does not allow for the withdrawal of the delivery system away from the clip, resulting in tissue...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-3056-2011
Status: Terminated
Initiated: 2011-07-19
Posted: 2011-08-22
Terminated: 2012-06-22
Recalling firm: Boston Scientific Corporation
Product: The Resolution II Clip, 155 cm size and 235 cm size, Boxes of 1, 10, and 20 clips consists of a pre-loaded, radiopaque single use clip on a flexible delivery system. Endoscopic Clipping Device, Hemorrhoidal Ligator. The device is used for clip placement within the GI tract for hemostatis ( mucosal defects, bleeding ulcer, arteries, polyps); endoscopic marking; and anchoring to affix jejunal feeding tubes to the wall of the small bowel, as a supplementary method for closure of GI tract luminal perforation <20 mm that can be treated conservatively.
Product code: FHN Ligator, Hemorrhoidal
Reason for recall: Boston Scientific has received reports where, following clip deployment, the alignment of the clip and delivery system does not allow for the withdrawal of the delivery system away from the clip, resulting in tissue trauma, increased bleeding and the clip being pulled off tissue as the delivery system is withdrawn.
FDA root cause: Other
Action: Boston Scientific sent an URGENT MEDICAL DEVICE RECALL letter dated August 12, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to forward the Medical Device Recall to their customers. Customers were instructed to: Immediately discontinue use of any affected product. Complete and return the Reply Verification Tracking Form by fax to 508-683-5578. Package and return any affected product to: Boston Scientific Corporation Distribution Center Attn: QA Returns 500 Commander Shea Blvd Quincy, MA 02171 For questions regarding this recall call 508-683-5578.
Quantity in commerce: 14, 093 boxes of both 155 cm and 235 cm size clips
Distribution: Worldwide Distribution - including USA (nationwide)
Product codes and lots: Catalog M00522500: Lot 1ML1013103, ML00000004, ML00000129, Catalog M00522501: Lot 1ML1013104, ML00000071, ML00000148, Catalog M00522502: Lot 1ML1013102, ML00000042, ML00000131, Catalog No. M00522501: Lot 1ML1011201, 1ML1013101, 1ML1020202, 1ML1021402, 1ML1022202, ML1022213,ML00000013, ML00000019, L00000058,ML00000073, ML00000098, ML00000120, Catalog No. M00522511: Lot 1ML1010605, 1ML1012602, 1ML1013105, 1ML1020203, 1ML1021403, 1ML1022203,1ML1022214, ML00000014, ML00000020,ML00000043, ML00000059, ML00000074,ML00000099, ML00000119, Catalog No. M00522512: Lot 1ML1011905, 1ML1020201, 1ML1021401, 1ML1022201, 1ML1022215, ML00000018,ML00000032, ML00000040, ML00000072,ML00000097, ML00000135, and ML00000137

Product code FHN

K102764Class IIResolution II ClipBoston Scientific Corporation / cleared 2010-12-22

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)