Maxon 8886 6245-61Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884523002492), received between Oct 11, 2017 and Mar 21, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 21, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A ROBOTIC ASSISTED HYSTERECTOMY, THE THREAD OF THE SUTURE BROKE AFTER THE CASE, AND THE OTHER NEEDLE BROKE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21661584 ↗
• MalfunctionSep 9, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING SUTURING, SUTURE MATERIAL DETACHED FROM THE NEEDLE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10511915 ↗
• MalfunctionMay 14, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE NEEDLE PULLED LOOSE FROM THE THREAD. THE SURGEON THEN USED ANOTHER DEVICE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE.

  Patient problems: No Information

  MAUDE report 10055585 ↗
• MalfunctionOct 30, 2017Break; Break

  ACCORDING THE REPORTER, DURING A PROCEDURE THE THREAD OF THE PRODUCT BROKE AND ON ANOTHER SUTURE, THE NEEDLE WAS DETACHED. A NEW SUTURE WAS OPENED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY NOTED DURING THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6987108 ↗
• MalfunctionOct 30, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING THE REPORTER, DURING A PROCEDURE, THE THREAD OF THE PRODUCT BROKE AND ON ANOTHER SUTURE, THE NEEDLE WAS DETACHED. A NEW SUTURE WAS OPENED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY NOTED DURING THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6987043 ↗
• MalfunctionOct 12, 2017Unraveled Material; Unraveled Material

  ACCORDING THE REPORTER, PRE-OPERATIVELY, THE THREAD PART OF THE PRODUCT WAS BROKEN AFTER 2-10 DAYS. THE SURGEON EMPLOYED CONTINUOUS SUTURE. THERE WAS A TEMPORARY INJURY TO THE PATIENT RELATED TO WOUND DEHISCENCE WITH OPEN ABDOMEN. REOPERATION WAS DONE APPROXIMATELY 3 DAYS POST OP WITH ABDOMINAL WASH AND RE-CLOSURE OF ABDOMINAL WALL WAS NECESSARY. THE PATIENT (DOG) WAS ALIVE WITH INJURY.

  Patient problems: Injury; No Code Available; Tissue Damage; Wound Dehiscence

  MAUDE report 6943775 ↗
• MalfunctionOct 11, 2017Unraveled Material; Unraveled Material

  ACCORDING THE REPORTER, PRE-OPERATIVELY, THE THREAD PART OF THE PRODUCT WAS BROKEN AFTER 2-10 DAYS. THE SURGEON EMPLOYED CONTINUOUS SUTURE. THERE WAS A TEMPORARY INJURY TO THE PATIENT RELATED TO WOUND DEHISCENCE WITH OPEN ABDOMEN. REOPERATION WAS DONE APPROXIMATELY 2 DAYS POST OP WITH ABDOMINAL WASH AND RE-CLOSURE OF ABDOMINAL WALL WAS NECESSARY. THE PATIENT (DOG) WAS ALIVE WITH INJURY.

  Patient problems: Injury; No Code Available; Tissue Damage; Wound Dehiscence

  MAUDE report 6940924 ↗

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: