Maxon 8886 6605-31Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10884523003932), received between Apr 13, 2018 and Aug 7, 2024 — classified as 2 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (8 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

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

  ACCORDING TO THE REPORTER, DURING A HEPATECTOMY PROCEDURE, WHEN THE DEVICE WAS TAKEN OUT OF THE RETAINER AND PREPARING FOR SUTURING, THE THREAD AND NEEDLE SEPARATED. THIS ISSUE OCCURRED ON TWO DEVICES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19928017 ↗
• MalfunctionJul 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LOW ANTERIOR RESECTION PROCEDURE, WHILE SUTURING THE DERMAL TISSUE, THE THREAD CAME OUT OF THE NEEDLE IN THE MIDDLE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19793590 ↗
• InjuryApr 20, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A DERMAL SUTURE, THE NEEDLE AND THREAD CAME OFF WHEN THE NEEDLE WAS CLAMPED WITH A NEEDLE HOLDER DEVICE. IT WAS NOTED THAT AN X-RAY WAS PERFORMED FOR THE CLEAR PURPOSE OF SPECIFYING THE NEEDLE POSITION OR CONFIRMING THE POSITION OF ALL PARTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Radiation Exposure

  MAUDE report 16777463 ↗
• MalfunctionFeb 14, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING AN ORTHOPEDIC SURGERY, WHILE SUTURING, THE NEEDLE BROKE. THE SAME PRODUCT TYPE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13524835 ↗
• MalfunctionDec 22, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, WHEN THE PACKAGE WAS OPENED AND TRIED TO USE THE SUTURE, THE NEEDLE AND THREAD CAME OFF. ANOTHER NEW SUTURE USED WITHOUT ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13058168 ↗
• InjuryJun 7, 2021Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, IN THE LATTER HALF OF THE WOUND CLOSURE, THE NEEDLE PART HELD BY THE NEEDLE HOLDER BROKE. ANOTHER SUTURE FROM THE SAME LOT WAS USED TO COMPLETE THE CASE. AN X-RAY WAS PERFORMED FOR THE EXPRESS PURPOSE OF LOCATING THE NEEDLE OR CONFIRMING THAT ALL PIECES WERE LOCATED.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 11947946 ↗
• MalfunctionAug 20, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A GYNECOLOGICAL DERMIS SUTURE, THE PRODUCT WAS NOT USED ON THE PATIENT, THE NEEDLE BROKE FROM THE SWEDGE PART. AFTER THAT, A NEW PRODUCT WAS TAKEN OUT, AND THE OPERATION ENDED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 10430318 ↗
• MalfunctionApr 2, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC PARTIAL COLECTOMY, DURING DERMAL SUTURING, THE THREAD CAME OFF THE NEEDLE. THE NEEDLE WAS BURIED UNDER THE PATIENT'S SKIN AND THERE WAS DIFFICULTY IN TAKING THE NEEDLE OUT. THE NEEDLE WAS EVENTUALLY RETRIEVED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9916333 ↗
• MalfunctionNov 14, 2019Break; Break

  ACCORDING TO THE REPORTER DURING A PROCEDURE, THE THREAD OF THE DEVICE BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9325241 ↗
• MalfunctionJul 2, 2019Break; Break

  ACCORDING TO THE REPORTER, THE NEEDLE BROKEN DURING THE PROCEDURE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8756039 ↗
• MalfunctionApr 26, 2019Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, WHEN THE PACKAGE WAS OPENED FOR DERMAL SUTURING, THE END OF THE THREAD WAS FOUND TO BE TANGLED AND COULD NOT BE USED. THE EVENT OCCURRED DURING THE PROCEDURE BUT THE PRODUCT WAS NOT USED FOR PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8557212 ↗
• MalfunctionApr 10, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, WHEN THE SURGEON TRIED TO USED THE DEVICE FOR CLOSING THE DERMIS, THE NEEDLE DETACHED EASILY FROM THE THREAD. THE EVENT OCCURRED DURING THE PROCEDURE BUT THE PRODUCT WAS NOT USED FOR PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8500219 ↗
• MalfunctionJul 3, 2018Break; Detachment Of Device Component; Break; Detachment Of Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GYNECOLOGIC PROCEDURE, THE NEEDLE BROKE AND FELL INTO THE PATIENT'S CAVITY AND WAS RETRIEVED. A NEW DEVICE WAS USED TO COMPLETE THE CASE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7658962 ↗
• MalfunctionJul 3, 2018Break; Detachment Of Device Component; Break; Detachment Of Device Component

  ACCORDING TO THE REPORTER, IN A GYNECOLOGY PROCEDURE, THE SUTURE BROKE WHILE KNOTTING. THE SECOND DEVICE WAS USED BUT THE NEEDLE BROKE WHILE INSERTING. THE PART FELL INTO THE PATIENT'S CAVITY AND WAS RETRIEVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7658875 ↗
• MalfunctionApr 13, 2018Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE NEEDLE PHYSICALLY BROKE 1MM FROM THE CONNECTING PART, BUT NOTHING FELL INTO THE PATIENT CAVITY. THEY THEN USED ANOTHER DEVICE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7428952 ↗

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: