Single Use Rotatable Clip Fixing Device HX-201UR-135 (REF N4540930)Recalls & reported problems
Olympus Medical Systems Corp. · Single Use Rotatable Clip Fixing Device · Class 2 · Implant
All models of Single Use Rotatable Clip Fixing Device (9)
Data updated Oct 18, 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 18, 2026.
Recalls naming this device
- Feb 23, 2023Class IIOpen, Classified
There have been complaints that the clip did not come out of the tube sheath during the procedure.
Z-1418-2023 · Root cause: Process change control · Recall details · FDA record ↗
Other Ligator, esophageal devices
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- Saeed G22692Cook Incorporated · Ligator, esophageal295 reports
- Saeed G22553Cook Incorporated · Ligator, esophageal289 reports
- SINGLE USE LIGATING DEVICE HX-400U-30Olympus Medical Systems Corp. · Ligator, Esophageal1 recall239 reports
- Saeed G31917Cook Incorporated · Ligator, esophageal123 reports
- SINGLE USE LIGATING DEVICE HX-400U-30Olympus Medical Systems Corp. · Ligator, Esophageal97 reports
- Single Use Rotatable Clip Fixing Device HX-201UR-135Olympus Medical Systems Corp. · Ligator, esophageal1 recall1 death10 reports
- Single Use Rotatable Clip Fixing Device HX-201UR-135LOlympus Medical Systems Corp. · Ligator, esophageal1 recall8 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 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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