Maxon GMMT-540-MGRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10884523004434), received between Jun 24, 2022 and Jul 22, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (10 reports).

1 other recall cover devices cleared under the same FDA submission (K990951); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PREOPERATIVELY, ALL FIVE SUTURES HAD COME OFF. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22569036 ↗
• MalfunctionJul 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PREOPERATIVELY, ALL FIVE SUTURES HAD COME OFF. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22568992 ↗
• MalfunctionJul 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PREOPERATIVELY, ALL FIVE SUTURES HAD COME OFF. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22568835 ↗
• MalfunctionJul 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PREOPERATIVELY, ALL FIVE SUTURES HAD COME OFF. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22568669 ↗
• MalfunctionJul 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PREOPERATIVELY, ALL FIVE SUTURES HAD COME OFF. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22568642 ↗
• MalfunctionJun 4, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE AND THREAD WERE NOT FIRMLY ATTACHED AND TEND TO DETACH WHEN REMOVED FROM THE PACKAGE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22147106 ↗
• MalfunctionJun 3, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING GASTRECTOMY WITH ROBOT SUPPORT (DA VINCI XI), BEFORE THE SURGICAL INCISION CLOSURE, WHEN THE THREAD WAS PASSED THROUGH THE 8 MM PORT WOUND, AND THE FASCIAL SUTURE WAS PERFORMED, THE THREAD WAS TIGHTENED, AND THE THREAD BROKE ON THE CENTER PART IMMEDIATELY AND COULD NOT BE TIED. A NEW SUTURE WAS USED WITHOUT ANY PROBLEM. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22133305 ↗
• MalfunctionMay 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC DUODENAL PERFORATION, BEFORE PATIENT USE, THE SUTURE WAS EASILY DETACHED FROM THE NEEDLE SWAGE AND COULD NOT BE USED NORMALLY. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22094109 ↗
• MalfunctionMay 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A DA VINCI PANCREATIC HEAD TUMOR SURGERY, WHEN THE ABDOMEN WAS CLOSED, THE SUTURE EASILY GET DETACHED FROM THE NEEDLE SWAGE AND COULD NOT BE USED NORMALLY. THE OPERATION WAS COMPLETED WITHOUT ANY PROBLEMS BY TAKING OUT A NEW PRODUCT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22094062 ↗
• MalfunctionMay 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC DUODENAL PERFORATION CASE, IN ABDOMINAL CLOSURE (MUSCLE LAYER STITCHING), THE JUNCTION BETWEEN THE NEEDLE AND THREAD WAS WEAK AND DETACHED WITH JUST A TOUCH, SO IT WAS NOT USED IN THE SURGICAL FIELD. A NEW PRODUCT WAS TAKEN OUT AND THE SURGERY WAS PERFORMED, AND THE OPERATION WAS COMPLETED WITHOUT ANY PROBLEM. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22075104 ↗
• MalfunctionJun 24, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC TOTAL GASTRECTOMY, PRIOR TO USE IN PATIENT, WHEN THE NEEDLE WAS PULLED OUT FROM THE PACKAGE WITH THE NEEDLE HOLDER; THE NEEDLE CAME OFF FROM THE THREAD TWICE CONTINUOUSLY. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED.

  Patient problems: Insufficient Information

  MAUDE report 14806534 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K990951. One submission often covers many models, so check the product and lot details in each record.

• Z-2542-2017 · May 3, 2017 · Terminated
  Sutures. MAXON: MAXON 4/0 5X18" GREEN CV-24 D-TACH; Item Number: 8886621933; MAXON 5/0 5X18 GR CV-23 D-TACH; Item Number: XX2109; MAXON* 4/0 5X30 GREEN V-20 D*TACH; Item Number: