Maxon 8886 6059-41Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10884523001921), received between Oct 25, 2017 and May 6, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (9 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING A HERNIA PROCEDURE, WHEN WITHDRAWING FROM THE RETAINER AND PREPARING FOR SUTURING, THE SWAGE BROKE AND IT WAS NOTED THAT THERE WAS DIFFICULTY WITHDRAWING THE SUTURE FROM THE RETAINER. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21965633 ↗
• MalfunctionDec 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO A PROCEDURE, UPON OPENING THE PACKAGE, THE NEEDLE WAS FOUND DETACHED FROM THE THREAD. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18411431 ↗
• MalfunctionJun 20, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, ON AN OPEN ABDOMINAL GASTRIC RESECTION, DURING CLOSURE, PRIOR TO USING THE DEVICE, THE THREAD WAS FOUND TO HAVE COME OFF THE NEEDLE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14748865 ↗
• MalfunctionJun 16, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING TOTAL GASTRECTOMY, WHEN OPENING THE PRODUCT, THE NEEDLE WAS FOUND TO BE DISENGAGED FROM THE THREAD, SO THE PRODUCT WAS NOT USED. ANOTHER PACKET WAS OPENED. THE EVENT OCCURRED DURING THE PROCEDURE, BUT THE PRODUCT WAS NOT USED FOR PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10157469 ↗
• MalfunctionNov 12, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO LOW ANTERIOR RESECTION, WHEN THE PACKAGE WAS OPENED, THE NEEDLE AND THREAD WERE FOUND TO BE DISENGAGED. WHEN ANOTHER PACKAGE WAS OPENED, THERE WAS NO PROBLEM, SO THE OPERATION WAS CONTINUED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9313396 ↗
• MalfunctionJul 1, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE OPERATIVELY, WHEN THE PRODUCT WAS OPENED, THE NEEDLE AND THE THREAD WERE FOUND NOT TO BE CONNECTED. A NEW PRODUCT WAS OPENED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8750301 ↗
• MalfunctionJun 13, 2019Break; Material Twisted/Bent; Break; Material Twisted/Bent

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE NEEDLE WAS BENT EASILY AND THREAD BROKE EASILY. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8695718 ↗
• MalfunctionDec 18, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE FOR SUBCUTANEOUS SUTURING TO CLOSE THE WOUND, WHEN THE NEEDLE WAS TAKEN OUT OF THE PACKAGE, THE THREAD CAME OFF THE NEEDLE. THE PRODUCT WAS DISCARDED AND A NEW ONE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8177034 ↗
• MalfunctionJul 24, 2018Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, WHEN OPENING THE PACKAGE, THE NEEDLE WAS ALREADY DISENGAGED FROM THREAD. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE EVENT OCCURRED DURING THE PROCEDURE BUT THE PRODUCT WAS NOT USED FOR PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7714568 ↗
• MalfunctionOct 25, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER: THE NEEDLE CAME OFF THE THREAD EASILY. THE EVENT OCCURRED DURING THE PROCEDURE BUT THE PRODUCT WAS NOT USED ON THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT HARM. THE STATUS OF THE PATIENT IS NO PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6976177 ↗

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: