Maxon 8886613431-2Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10884521757783), received between May 20, 2021 and Dec 2, 2025 — 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.

• MalfunctionDec 2, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A WHIPPLE PROCEDURE, WHILE BEING USED ON THE ANASTOMOSIS, THE NEEDLE DETACHED FROM THE SUTURE LENGTH WHILE SUTURING AFTER PATIENT INCISION. THE NEEDLE FELL INTO THE PATIENT CAVITY AND WAS SUBSEQUENTLY FOUND IN THE PANCREAS. THE PROCEDURE WAS EXTENDED BY 20-30 MINUTES AS THE SURGEON SEARCHED FOR THE SUTURE NEEDLE, UTILIZING ULTRASOUND AND A CHOLEDOCHOSCOPE TO LOCATE IT. THE NEEDLE WAS RETRIEVED, AND AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23692492 ↗
• MalfunctionJan 6, 2025Break; Break

  IT WAS REPORTED THAT DURING A LAPAROTOMY PROCEDURE, TWO MAXON 4-0 SUTURES BROKE WHILE SUTURING. THE SURGEON USED ANOTHER SUTURE TO C OMPLETE THE PROCEDURE WITHOUT FURTHER ISSUES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21087238 ↗
• MalfunctionJan 6, 2025Break; Break

  IT WAS REPORTED THAT DURING A LAPAROTOMY PROCEDURE, TWO MAXON 4-0 SUTURES BROKE WHILE SUTURING. THE SURGEON USED ANOTHER SUTURE TO COMPLETE THE PROCEDURE WITHOUT FURTHER ISSUES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21087228 ↗
• MalfunctionNov 13, 2024Detachment of Device or Device Component; Difficult to Open or Remove Packaging Material; Detachment of Device or Device Component; Difficult to Open or Remove Packaging Material

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE WAS DIFFICULT TO WITHDRAW FROM THE RETAINER. ADDITIONALLY, WHILE WITHDRAWING THE DEVICE FROM THE RETAINER TO PREPARE FOR SUTURING, THE SUTURE WAS DISCONNECTED FROM THE SWAGE. THESE ISSUES OCCURRED ON TWO DEVICES. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20676063 ↗
• MalfunctionNov 13, 2024Detachment of Device or Device Component; Difficult to Open or Remove Packaging Material; Detachment of Device or Device Component; Difficult to Open or Remove Packaging Material

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE WAS DIFFICULT TO WITHDRAW FROM THE RETAINER. ADDITIONALLY, WHILE WITHDRAWING THE DEVICE FROM THE RETAINER TO PREPARE FOR SUTURING, THE SUTURE WAS DISCONNECTED FROM THE SWAGE. THESE ISSUES OCCURRED ON TWO DEVICES. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20675987 ↗
• MalfunctionJun 21, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, WHILE SUTURING THE NEEDLE OF THE DEVICE BROKE AND FELL INTO THE PATIENT'S CAVITY AND WAS RETRIEVED. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17176998 ↗
• MalfunctionFeb 3, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER INTRAOPERATIVELY, AFTER PULLING THE SUTURE OUT OF PACKAGE, THE NEEDLE POPPED OFF OF WITH THE SUTURE WHEN BEING LOADED INTO THE NEEDLE DRIVER. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 13442092 ↗
• MalfunctionMay 20, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A BOWEL RESECTION, THE NEEDLE DETACHED FROM THE SUTURE WHEN FORCE WAS APPLIED. ANOTHER SUTURE FROM THE SAME BOX WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11855036 ↗

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: