Reliamax GIA8048RLRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20884521168647), received between Jul 10, 2017 and Jan 5, 2022 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 5, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OPEN GASTROINTESTINAL ANASTOMOSIS PROCEDURE, THE DEVICE DID NOT FIRE. THE BLACK PUSHER THUMB PIECE CANNOT BE MOVED AT ALL. THE LOADING UNIT WAS REPLACED TO COMPLETE THE CASE AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13168935 ↗
• MalfunctionAug 4, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, ON AN OPEN ANTERIOR RESECTION, DURING RESECTION, A PART OF THE RELOAD DISENGAGED. ANOTHER RELOAD WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10365278 ↗
• MalfunctionMay 22, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A RIGHT HEMICOLECTOMY, DURING TRANSECTION OF COLON, THE DEVICE DID NOT FIRE. THEY OPENED ANOTHER R ELOAD TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8632390 ↗
• InjurySep 24, 2018Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING AN OPEN TRIPLE BYPASS AND SPECIMEN WAS TAKEN FROM THE PANCREATIC HEAD, THERE WAS A POOR STAPLE FORMATION AND BLEEDING FROM THE STAPLE LINE. THE STAPLE LINE WAS FIXED THRU OVER SEWING IN ORDER TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THE SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MINUTES.

  Patient problems: No Code Available

  MAUDE report 7902242 ↗
• MalfunctionJul 10, 2017Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER: OCCURRED DURING AN OPEN PARTIAL GASTRECTOMY. DURING THE DUODENAL STUMP AND STOMACH RESECTIONING, THE STAPLES DID NOT DEPLOY FROM THE LOADING UNITS. THERE WAS SURGICAL INTERVENTION REQUIRED BECAUSE THE TISSUE HAD TO BE HAND SUTURED. THERE WAS NO EXTENSION IN SURGICAL TIME.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 6697730 ↗