REFLEX 8735Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20653405037016), received between Jun 3, 2024 and Jul 7, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Failure to Eject” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 7, 2025Failure to Eject; Failure to Eject

  THE CUSTOMER REPORTED THAT THE THAT 8735, REFLEX TL, SKIN STAPLER WITH TISSUE LIFT, 35 WIDE DEVICE WAS BEING USED DURING A CLOSURE OF A LACERATION PROCEDURE ON APPROXIMATELY (B)(6) 2025 WHEN IT WAS REPORTED ¿STAPLE GUN JAMMED. THERE WAS NO PATIENT INJURY. JUST A SMALL DELAY IN THE PROCEDURE. GUN WAS DISPOSED OF.¿. FURTHER ASSESSMENT QUESTIONING FOUND THAT ¿IT GOT STUCK IN HIS HEAD AND THE PROVIDER HAD TO PRY THE DEVICE OFF.". THE PROCEDURE WAS COMPLETED AND THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22410604 ↗
• MalfunctionAug 20, 2024Failure to Disconnect; Failure to Disconnect

  THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE DEVICE, 8735, REFLEX TL, SKIN STAPLER WITH TISSUE LIFT, 35 WIDE, WAS BEING PRE-OP TESTED FOR AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE WHEN IT WAS REPORTED, ¿IT DIDN¿T RELEASE SO I HAD TO PLACE ANOTHER STAPLE IN ORDER FOR IT TO RELEASE.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20007514 ↗
• InjuryJun 3, 2024Failure to Eject; Failure to Eject

  A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE 8735, REFLEX TL, SKIN STAPLER WITH TISSUE LIFT, 35 WIDE DEVICE WAS BEING USED DURING A SCALP LACERATION REPAIR ON (B)(6) 2024, AND ¿THE STAPLER DID NOT RELEASE ONCE IN THE PATIENT'S SCALP¿. THROUGH FOLLOW-UP ASSESSMENT, THE PHYSICIAN STATED: ¿I HAD TO REMOVE THE STAPLES THAT STUCK TO THE SCALP AND STAPLER BECAUSE THEY STAPLED TO HIGH ABOVE THE SCALP. I HAD TO TRIGGER THE STAPLER AGAIN TO RELEASE THE FIRST ONE AND THEN THE SECOND ONE DID THE SAME THING AND I HAD TO JIGGLE AND MOVE AROUND THE STAPLER TO RELEASE THE SECOND ONE. EVENTUALLY AFTER MANIPULATION AND MOVING AROUND THE STAPLER WHILE STILL IN THE SCALP IT RELEASED. OUT OF THE 4 THAT WAS DEPLOYED I HAD TO REMOVE 2 OF THEM BEFORE USING THE SMALLER STAPLER DEVICE¿. THE PHYSICIAN DESCRIBED AN OUTCOME OF INJURY DUE TO THE PATIENT HAVING "HAD MORE PAIN WITH MOVING AROUND THE STAPLER DEVICE STUCK TO THE SCALP. HE HAD SOME BLEEDING FROM THE MANIPULATION THAT WAS ABLE TO BE STOPPED WITH PRESSURE.". THERE WAS NO REPORTED DELAY AND NO REPORT OF MEDICAL/SURGICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. THE PATIENT¿S CONDITION IS ¿STABLE¿. THIS REPO

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain

  MAUDE report 19447222 ↗