Single Use Repositionable Clip HX-202LR (UDI 04953170385919)Recalls & reported problems
Olympus Medical Systems Corp. · Class 2 · Implant
All models of Single Use Repositionable Clip (7)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Recalls naming this device
- May 4, 2023Class IIOpen, Classified
Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deploy incorrectly, potentially causing harms to patients. The complaints include reports that: 1) the clip arm does not open when the user pushes the slider, 2) the clip arm does not close when the user pulls the slider and 3) the clip detaches from the target tissue earlier than expected, after being deployed in a procedure.
Z-1987-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Other Hemostatic metal clip for the GI tract devices
- Resolution 360 Clip M00521230Boston Scientific Corporation · Hemostatic metal clip for the GI tract3 deaths2,291 reports
- 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
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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