Maxon 8886 6213-11Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10884523002294), received between May 24, 2019 and Aug 14, 2026 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (13 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50251392 ↗
• MalfunctionAug 14, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50251376 ↗
• MalfunctionDec 15, 2025Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A PROCEDURE, WHILE SUTURING THE INCISION, THE SUTURE AND NEEDLE WERE DETACHED. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23812088 ↗
• MalfunctionDec 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING SUTURING THE INCISION, BOTH NEEDLE AND THREAD BROKE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23706542 ↗
• MalfunctionNov 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING AN OPEN PROCEDURE, WHILE EMPLOYING A CONTINUOUS SUTURING TECHNIQUE IN INCISION SUTURING, THE NEEDLE AND THREAD DETACHED. TO RESOLVE THE ISSUE, A NEW SUTURE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23566388 ↗
• MalfunctionNov 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A COSMETIC SKIN SUTURE, THE NEEDLE AND THREAD DETACHED.

  Patient problems: Insufficient Information

  MAUDE report 23487058 ↗
• MalfunctionNov 3, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, IN SKIN CLOSURE, THE TAIL END OF THE NEEDLE BROKE. THE BROKEN FRAGMENT WAS THEN LOCATED, AND A NEW SUTURE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23444599 ↗
• MalfunctionAug 19, 2025Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING AN OPEN INCISION SUTURE PROCEDURE, WHEN SUTURING USING A CONTINUOUS SUTURE TECHNIQUE, THE NEEDLE DETACHED FROM THE THREAD AS A WHOLE. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22846019 ↗
• MalfunctionJul 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE SUTURE WAS DISCONNECTED FROM THE NEEDLE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE.

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

  MAUDE report 22620780 ↗
• MalfunctionOct 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN ATRIAL SEPTAL DEFECT REPAIR PROCEDURE, WHEN THE SURGEON WAS USING THE SUTURE, IT WAS FOUND THAT THE NEEDLE AND THE THREAD HAD DETACHED. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20432077 ↗
• MalfunctionFeb 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY OF VETERINARY PROCEDURE, THE NEEDLE AND SUTURE CAME OFF. A NEW PRODUCT WAS OPENED AND USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16362765 ↗
• MalfunctionJan 19, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO PROCEDURE, WHEN THE PACKAGE OF THE SUTURE WAS OPENED BEFORE DEVICE WAS IMPLANTED, THE NEEDLE WAS FOUND SEPARATED FROM THE MONOFILAMENT AND WAS NOT USED BECAUSE NEEDLE FELL DOWN. THE SAME ISSUE OCCURRED WITH TWO SUTURES. THERE WAS AN ADDITIONAL SUTURE USED WITHOUT ISSUE THAT RESOLVED THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16203748 ↗
• MalfunctionOct 27, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO PROCEDURE, WHEN THE PACKAGE OF THE SUTURE WAS OPENED BEFORE DEVICE WAS IMPLANTED, THE NEEDLE WAS FOUND SEPARATED FROM THE MONOFILAMENT AND WAS NOT USED BECAUSE NEEDLE FELL DOWN. THE SAME ISSUE OCCURRED WITH TWO SUTURES. THERE WAS AN ADDITIONAL SUTURE USED WITHOUT ISSUE THAT RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15679391 ↗
• MalfunctionJan 11, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN EMERGENCY SURGERY, TRAUMA TO THE ARM OF THE CHILD, WHEN THE DOCTOR PREPARED TO SUTURE THE WOUND OF A CHILD, THREAD AND THE NEEDLE WERE FOUND DETACHED AND THE SUTURE WAS EASY TO BREAK FOR THREE CONSECUTIVE TIMES. AFTER REPLACING 3 PACKS, CONFIRMED THAT THE SUTURE HAD NO QUALITY PROBLEMS BEFORE USING IT ON THE CHILD. REPLACED WITH OTHER SUTURES TO RESOLVE THE ISSUE. IT DID NOT CAUSE HARM TO THE CHILD, BUT IT DELAYED TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11146909 ↗
• MalfunctionMay 24, 2019Device Slipped; Device Slipped

  ACCORDING TO THE REPORTER, DURING A RHINOPLASTY PROCEDURE, THE KNOT OF THE SUTURE KEEPS OPENING. THE PROBLEM WAS FIXED BY THROWING MORE THAN ONE NODE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8640113 ↗

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: