Resolution 360 Clip M00521230Recalls & reported problems
Boston Scientific Corporation · Working Length 235cm, Working Channel 2.8mm · Class 2 · Implant
Quick summary
This Boston Scientific Resolution 360 clip is a metal clip used to stop bleeding in the digestive tract during endoscopy. Its 2,276 reports often describe the clip not deploying, releasing or staying in place, and some describe clips breaking or deploying too early. They mention 76 injuries and 4 deaths, and some mention bleeding. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 2,291
- Deaths reported
- 3
- Injuries reported
- 72
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2,291 adverse event reports that list this exact device (DI 08714729875628), received between Dec 21, 2016 and Sep 30, 2026 — classified as 3 deaths, 72 injuries, 2,216 malfunctions.
The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (2,004 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Activation, Positioning or Separation Problem2,004
- Break210
- Adverse Event Without Identified Device or Use Problem208
- Difficult to Open or Close158
- Premature Activation154
- Human-Device Interface Problem78
- Entrapment of Device67
- Detachment of Device or Device Component61
Patient problems
- No Clinical Signs, Symptoms or Conditions1,307
- No Consequences Or Impact To Patient783
- No Known Impact Or Consequence To Patient135
- Hemorrhage/Blood Loss/Bleeding65
- Unspecified Tissue Injury23
- Insufficient Information22
- No Code Available7
- Perforation6
Recent adverse event reports
The 25 most recent of 2,291 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Entrapment of Device; Difficult to Remove; Difficult to Advance; Material Integrity Problem
It was reported to Boston Scientific Corporation that a Resolution 360 Clip was used during a colonoscopy procedure on (b)(6)2026 for treatment of a lower gastrointestinal bleed.During the procedure, the Resolution 360 Clip was opened and closed. The staff then determined that the clip was not required due to the presence of excessive debris in the colon. During retrieval of the clip from the scope, the clip was no longer attached and was later found within the scope during the cleaning process. The scope was sent for repair.There were no reported patient complications. The procedure was completed, without the use of the Resolution 360 Clip, as the clip was determined not to be required.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946691 ↗MalfunctionSep 23, 2026Break; Activation, Positioning or Separation Problem
It was reported to Boston Scientific Corporation that a Resolution 360 Clip was used during an unknown procedure on (b)(6) 2026. During the procedure, the Resolution 360 Clip had the spring come out of the handle and became difficult to deploy. The clip was able to be attached to the mucosa and be deployed. A second clip was used, and the same issue was observed. There were no reported patient complications. The procedure was completed but it is unknown what was used to complete the procedure. Note: This is the second clip of two clips used in the same procedure.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50868385 ↗MalfunctionSep 23, 2026Break; Activation, Positioning or Separation Problem
It was reported to Boston Scientific Corporation that a Resolution 360 Clip was used during an unknown procedure on (b)(6) 2026.During the procedure, the Resolution 360 Clip had the spring come out of the handle and became difficult to deploy. The clip was able to be attached to the mucosa and be deployed. A second clip was used, and the same issue was observed.There were no reported patient complications. The procedure was completed with another of the same device.Note: This is the first clip of two clips used in the same procedure.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50868382 ↗MalfunctionSep 23, 2026Break; Activation, Positioning or Separation Problem
It was reported to Boston Scientific Corporation that a Resolution 360 Clip was used during an endoscopic clipping procedure on (b)(6) 2026 for treatment of a small bleed.During the procedure, the Resolution 360 Clip upon attaching to the tissue would not release and the spring from the handle had come out, however, the staff was able to manage to release the clip by wiggling it. There were no reported patient complications. The procedure was completed with another of the same device.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50868381 ↗MalfunctionSep 18, 2026Activation, Positioning or Separation Problem
It was reported to Boston Scientific Corporation that a Resolution 360 Clip was used in the colon during an Endoscopic Mucosal Resection (EMR) procedure performed on (b)(6)2026.During the procedure, the clip could not be deployed. The procedure was completed with another of the same device. There were no patient complications reported as a result of this event. The patient's condition at the conclusion of the procedure was reported to be stable.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50820537 ↗MalfunctionSep 18, 2026Activation, Positioning or Separation Problem; Human-Device Interface Problem
It was reported to Boston Scientific Corporation that a Resolution 360 Clip was used during a polypectomy procedure performed on (b)(6)2026.During the procedure, the clip was not completely release from the catheter during deployment, it remained partially attached to the activation wire. The clip was pulled on for complete release, and at that moment it was detached from the mucosa. There were no patient complications reported as a result of this event.Boston Scientific has been unable to obtain additional information regarding the procedure details to date, despite good faith efforts.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50819351 ↗MalfunctionSep 18, 2026Activation, Positioning or Separation Problem
It was reported to Boston Scientific Corporation that a Resolution 360 Clip was used in the colon during a colonoscopy procedure performed on (b)(6)2026 for the treatment during a biopsy.During the procedure, the clip was able to grasp and lock onto tissue but failed to deploy. The procedure was completed with another device of a different size. There were no patient complications reported as a result of this event. The patient's condition at the conclusion of the procedure was reported to be stable.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50819151 ↗MalfunctionSep 18, 2026Activation, Positioning or Separation Problem; Human-Device Interface Problem
It was reported to Boston Scientific Corporation that a Resolution 360 Clip was used on an unknown anatomical location during a polypectomy procedure performed on(b)(6)2026. During the procedure, after the hemoclip was positioned, the device was activated and closed; however, the hemoclip was not completely released from the device, remaining partially attached to the activation wire, making it necessary to pull on it for complete release. At that moment, the hemoclip detached from the mucosa. No information regarding the procedure outcome was provided. No patient complications were reported as a result of this event. Boston Scientific has been unable to obtain additional information, despite good faith efforts.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50817737 ↗MalfunctionSep 17, 2026Activation, Positioning or Separation Problem
It was reported to Boston Scientific Corporation that a Resolution 360 Clip was used during a procedure.During the procedure, when the clip was deployed it failed to release from the catheter. There were no patient complications reported as a result of this event.Boston Scientific has been unable to obtain additional information regarding the procedure details to date, despite good faith efforts.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50803379 ↗MalfunctionSep 17, 2026Activation, Positioning or Separation Problem
It was reported to Boston Scientific Corporation that a Resolution 360 Clip was used during a procedure.During the procedure, when the clip was deployed it failed to release from the catheter. There were no patient complications reported as a result of this event.Boston Scientific has been unable to obtain additional information regarding the procedure details to date, despite good faith efforts.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50803378 ↗MalfunctionSep 17, 2026Activation, Positioning or Separation Problem
It was reported to Boston Scientific Corporation that a Resolution 360 Clip was used during a procedure.During the procedure, when the clip was deployed it failed to release from the catheter. There were no patient complications reported as a result of this event.Boston Scientific has been unable to obtain additional information regarding the procedure details to date, despite good faith efforts.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50803374 ↗MalfunctionSep 17, 2026Activation, Positioning or Separation Problem
It was reported to Boston Scientific Corporation that a Resolution 360 Clip was used during a procedure.During the procedure, when the clip was deployed it failed to release from the catheter. There were no patient complications reported as a result of this event.Boston Scientific has been unable to obtain additional information regarding the procedure details to date, despite good faith efforts.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50803372 ↗MalfunctionSep 16, 2026Activation, Positioning or Separation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796515 ↗MalfunctionSep 16, 2026Activation, Positioning or Separation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50792363 ↗MalfunctionSep 4, 2026Break; Activation, Positioning or Separation Problem; Difficult to Advance; Human-Device Interface Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50600729 ↗MalfunctionSep 4, 2026Activation, Positioning or Separation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50600721 ↗MalfunctionSep 4, 2026Activation, Positioning or Separation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50600335 ↗MalfunctionSep 4, 2026Activation, Positioning or Separation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50600333 ↗MalfunctionSep 4, 2026Break; Activation, Positioning or Separation Problem; Difficult to Advance
Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury
MAUDE report 50600118 ↗MalfunctionSep 3, 2026Activation, Positioning or Separation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50599925 ↗MalfunctionSep 3, 2026Difficult to Open or Close; Human-Device Interface Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50599888 ↗MalfunctionSep 1, 2026Activation, Positioning or Separation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50550088 ↗MalfunctionAug 21, 2026Break; Positioning Failure; Difficult to Open or Close; Human-Device Interface Problem; Material Integrity Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50379355 ↗MalfunctionAug 21, 2026Break; Positioning Failure; Difficult to Open or Close; Human-Device Interface Problem; Material Integrity Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50379217 ↗MalfunctionAug 20, 2026Premature Activation
It was reported to Boston Scientific Corporation that a Resolution 360 Clip was used during an unknown procedure on (b)(6)2026 for treatment of irregular tissue of the digestive tract.During the procedure, when opening the packaging, it was noted that the Resolution 360 Clip had already been released inside of the packaging prior to any handling or any attempted deployment.There were no reported patient complications. The procedure was completed with another of the same device.No further information has been obtained despite Good Faith Efforts.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50354611 ↗
Other Hemostatic metal clip for the GI tract devices
- Resolution Clip M00522610Boston Scientific Corporation · Hemostatic metal clip for the GI tract1,116 reports
- Instinct G58010Cook Incorporated · Hemostatic metal clip for the GI tract1 recall1,017 reports
- Resolution 360™ ULTRA Clip M00521400Boston Scientific Corporation · Hemostatic metal clip for the GI tract3 deaths496 reports
- Instinct G18343Cook Incorporated · Hemostatic metal clip for the GI tract244 reports
- MANTIS™ Clip M00521420Boston Scientific Corporation · Hemostatic metal clip for the GI tract195 reports
- Single Use Repositionable Clip HX-202UROlympus Medical Systems Corp. · Hemostatic metal clip for the GI tract1 recall118 reports
- colonic FTRD Set 14Ovesco Endoscopy AG · Hemostatic Metal Clip For The Gi Tract2 deaths95 reports
- Single Use Repositionable Clip HX-202UROlympus Medical Systems Corp. · Hemostatic metal clip for the GI tract87 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.