Maxon 8886 6608-41Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10884523003963), received between Apr 2, 2018 and Nov 7, 2024 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 16, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE NEEDLE POPPED OFF.

  Patient problems: Insufficient Information

  MAUDE report 20633623 ↗
• MalfunctionAug 17, 2023Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, WITH THREE SUCCESSIVE PACKETS, THE SUTURES BROKE WITH LIGHT FORCE. THE FOURTH PACKET COULD BE USED WITHOUT ANY PROBLEMS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17566949 ↗
• MalfunctionJul 25, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A HERNIA REPAIR PROCEDURE, THE THREAD AND NEEDLE OF THE SUTURE BROKE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17390623 ↗
• MalfunctionAug 15, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PREOPERATIVELY, WHEN THE NEEDLE HOLDER WAS USED TO GRASP THE NEEDLE TO REMOVE IT FROM THE PACKAGING, THE NEEDLE DETACHED LEAVING THE SUTURE MATERIAL WITHIN THE PACKAGING. THE SAME OCCURRED WITH TWO MORE SUTURES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15228753 ↗
• MalfunctionJul 26, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE THREAD BROKE. ANOTHER SUTURE FROM THE SAME BOX WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15108751 ↗
• MalfunctionSep 17, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING WOUND CLOSURE DERMAL SUTURING AFTER TOTAL HYSTERECTOMY, WHEN THE ALUMINUM PACKAGE WAS OPENED IN ORDER TO USE THE REPORTED PRODUCT, THE NEEDLE AND THE THREAD WERE DISENGAGED AND COULD NOT BE USED. ANOTHER DEVICE FROM THE SAME LOT WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12487721 ↗
• MalfunctionAug 26, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PREOPERATIVELY, WHEN REMOVED FROM THE PACKAGING AND LOADED ON THE NEEDLE HOLDER, NEEDLES DETACHED FROM 11 SUTURES WITHOUT EXCESSIVE FORCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12372667 ↗
• MalfunctionJul 5, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE NEEDLE KEPT POPPING OF THE SUTURE.

  Patient problems: Insufficient Information

  MAUDE report 12119328 ↗
• MalfunctionJul 29, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING SUTURING, THE DEVICE BROKE.

  Patient problems: No Information

  MAUDE report 10339397 ↗
• MalfunctionJun 29, 2020Break; Break

  ACCORDING TO THE REPORTER, SEVERAL SUTURES FROM TWO BOXES HAVE BEEN BREAKING WHILE THE SURGEON WAS SEWING.

  Patient problems: No Information

  MAUDE report 10205435 ↗
• MalfunctionJun 29, 2020Break; Break

  ACCORDING TO THE REPORTER, SEVERAL SUTURES FROM TWO BOXES HAVE BEEN BREAKING WHILE THE SURGEON WAS SEWING.

  Patient problems: No Information

  MAUDE report 10205419 ↗
• MalfunctionFeb 25, 2020Break; Break

  ACCORDING TO THE REPORTER, AT THE FIRST STITCH DURING MASTECTOMY, THE NEEDLE BROKE AT NEEDLE SWAGE IN THE MIDDLE OF SUTURING. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9749532 ↗
• MalfunctionApr 2, 2018Component Missing; Detachment of Device or Device Component; Component Missing; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO USE, WHEN THE BOX WAS OPENED, ONE NEEDLE CAME OFF AND ONE SUTURE DIDN'T HAVE A NEEDLE ON IT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 7389072 ↗

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: