RePlay 1170-02Recalls & reported problems
Diversatek Healthcare, Inc. · RePlay Hemostasis Clip, 16mm span · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00816734021491), received between Nov 22, 2023 and Dec 13, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Expulsion” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Expulsion1
- Material Integrity Problem1
- Mechanical Problem1
Patient problems
- Gastrointestinal Hemorrhage1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 13, 2024Mechanical Problem; Material Integrity Problem; Mechanical Problem; Material Integrity Problem
DURING A ROUTINE COLONOSCOPY, THE 16MM HEMOSTASIS CLIP MALFUNCTIONED UPON DEPLOYMENT, EXPOSING A PIECE OF WIRE AT THE END OF THE DEPLOYED CLIP. THE CLIP DEPLOYED AND HELD TISSUE AS INTENDED. THE CLIP WAS NOT REMOVED AFTER DEPLOYMENT PER THE DOCTOR, HE FELT IT WAS SAFER TO LEAVE THE CLIP AND LET IT PASS NATURALLY RATHER THAN REMOVE IT. THERE WAS NO PATIENT HARM, BUT THE PRODUCT PROBLEM RESULTED IN AN EXPOSED WIRE WITHIN THE GI TRACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20924614 ↗InjuryNov 22, 2023Expulsion; Adverse Event Without Identified Device or Use Problem; Expulsion; Adverse Event Without Identified Device or Use Problem
PATIENT HAD A COLONOSCOPY ON 10-27-2023. ONE 13MM POLYP WAS REMOVED IN THE CECUM AND THE RESECTED AREA WAS CLIPPED. ONE 12MM POLYP WAS REMOVED IN THE MID-ASCENDING COLON AND THAT RESECTED AREA WAS ALSO CLIPPED. THE CLIPS DEPLOYED PROPERLY AND THE EXAMINATION WAS NORMAL ON DIRECT AND RETROFLEXION VIEWS. ON (B)(6) 2023, THE PATIENT RETURNED TO THE ER WITH BLEEDING. ON (B)(6) 2023, THE PATIENT WAS RE-SCOPED. THAT EXAMINATION REPORTED THAT BOTH CLIPS HAD BEEN DISLODGED. NEW CLIPS WERE PLACED IN BOTH AREAS AND NO FURTHER INTERVENTION WAS NECESSARY.
Patient problems: Gastrointestinal Hemorrhage
MAUDE report 18191323 ↗
Other Hemostatic Metal Clip For The Gi Tract devices
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- 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 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- 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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