Maxon 8886621731-2Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10884521757820), received between Dec 9, 2022 and May 27, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2026Component Missing

  IT WAS REPORTED THAT DURING A PROCEDURE, THE NEEDLE WAS NOT ATTACHED. IT WAS NOT INCLUDED IN THE PACKET. THE DEVICE WAS NOT USED. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25299538 ↗
• MalfunctionJan 3, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PREOPERATIVELY OF A VETERINARY CASE, THE TWO NEEDLES DETACHED WHEN PULLING OUT FROM THE RETAINER AND PREPARING FOR SUTURING. A NEW SUTURE USED WITHOUT ANY PROBLEMS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23952855 ↗
• MalfunctionJan 3, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PREOPERATIVELY OF A VETERINARY CASE, THE TWO NEEDLES DETACHED WHEN PULLING OUT FROM THE RETAINER AND PREPARING FOR SUTURING. A NEW SUTURE USED WITHOUT ANY PROBLEMS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23952839 ↗
• MalfunctionApr 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING A PROCEDURE, WHILE PERFORMING A CONTINUOUS SUTURING TECHNIQUE ON THE SUBCUTANEOUS DERMAL, THE NEEDLE AND THREAD DETACHED. THE SURGEON HANDLED IT GENTLY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21901604 ↗
• MalfunctionJan 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING A ORTHOPEDIC PROCEDURE, THE NEEDLE WAS DETACHED, WHEN IT WAS BEING PULLED OUT FROM THE RETAINER AND PREPARING FOR SUTURING (BEFORE PATIENT USE). THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21232112 ↗
• MalfunctionJan 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING A ORTHOPEDIC PROCEDURE, THE NEEDLE WAS DETACHED, WHEN IT WAS BEING PULLED OUT FROM THE RETAINER AND  PREPARING FOR SUTURING (BEFORE PATIENT USE). THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21231628 ↗
• MalfunctionMar 16, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDECTOMY PROCEDURE, THE THREAD WAS CUT BY THE FORCE AFTER INTRACORPOREAL LIGATION, WHICH CANNOT BE CUT DURING NORMAL USE. A DIFFERENT PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16553316 ↗
• MalfunctionDec 9, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, BEFORE SUTURING, THE NEEDLE AND SUTURE WERE DISCONNECTED AFTER A FEW MINUTES WHEN THE PRODUCT WAS OPENED.

  Patient problems: Insufficient Information

  MAUDE report 15950266 ↗

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: