Resolution 360 ClipRecalls & reported problems across all models
Boston Scientific Corporation · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2,308
- Deaths reported
- 3
- Injuries reported
- 72
- Recalls
- 0
We found 2 models of Resolution 360 Clip by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 2,308 adverse event reports in the FDA's MAUDE database, received between Dec 21, 2016 and Sep 30, 2026 — classified as 3 deaths, 72 injuries, 2,233 malfunctions.
The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (2,018 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Resolution 360 Clip problems
Device problems
- Activation, Positioning or Separation Problem2,018
- Adverse Event Without Identified Device or Use Problem213
- Break211
- Difficult to Open or Close160
- Premature Activation155
- Human-Device Interface Problem80
- Entrapment of Device68
- Detachment of Device or Device Component63
Patient problems
- No Clinical Signs, Symptoms or Conditions1,319
- No Consequences Or Impact To Patient785
- No Known Impact Or Consequence To Patient138
- Hemorrhage/Blood Loss/Bleeding65
- Unspecified Tissue Injury23
- Insufficient Information22
- No Code Available7
- Perforation6
Resolution 360 Clip models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Resolution 360 Clip M00521230Hemostatic metal clip for the GI tract3 deaths2,291 reports
- Resolution 360 Clip M00521240Hemostatic metal clip for the GI tract17 reports
Recent Resolution 360 Clip adverse event reports
The 15 most recent reports across all models, 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 ↗
Other Boston Scientific Corporation products
- INGEVITY MRI7 models · 16,601 reports
- INGEVITY+3 models · 16,054 reports
- EMBLEM S-ICD4 models · 13,295 reports · 1 recall
- WATCHMAN25 models · 8,024 reports · 6 recalls
- AMS 800 Artificial Urinary Sphincter31 models · 7,515 reports · 2 recalls
- ENDOTAK RELIANCE SG9 models · 6,540 reports · 2 recalls
- RELIANCE 4-FRONT11 models · 5,739 reports
- FINELINE II EZ Sterox6 models · 5,633 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page