Maxon 8886 6618-51Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10884523001822), received between Mar 17, 2017 and May 8, 2024 — classified as 4 injuries, 6 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryMay 8, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A DEEP INFERIOR EPIGASTRIC PERFORATOR OPEN PROCEDURE, CLOSING THE INCISION, THE THREE NEEDLES BROKE AND ONE NEEDLE FELL INTO THE CAVITY OF THE PATIENT. AN X-RAY WAS PERFORMED, AND THE SURGICAL TIME WAS ALSO EXTENDED TO 30 MINUTES. IT WAS NOTED THAT NEEDLE WAS RETRIEVED. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 19268274 ↗
• InjuryMay 8, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A DEEP INFERIOR EPIGASTRIC PERFORATOR OPEN PROCEDURE, CLOSING THE INCISION, THE THREE NEEDLES BROKE AND ONE NEEDLE FELL INTO THE CAVITY OF THE PATIENT. AN X-RAY WAS PERFORMED, AND THE SURGICAL TIME WAS ALSO EXTENDED TO 30 MINUTES. IT WAS NOTED THAT NEEDLE WAS RETRIEVED. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 19268251 ↗
• InjuryMay 8, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A DEEP INFERIOR EPIGASTRIC PERFORATOR OPEN PROCEDURE, CLOSING THE INCISION, THE THREE NEEDLES BROKE AND ONE NEEDLE FELL INTO THE CAVITY OF THE PATIENT. AN X-RAY WAS PERFORMED, AND THE SURGICAL TIME WAS ALSO EXTENDED TO 30 MINUTES. IT WAS NOTED THAT NEEDLE WAS RETRIEVED. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 19268173 ↗
• MalfunctionApr 25, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A BREAST AUGMENTATION PROCEDURE, THE SWAGED PART OF THE NEEDLE/THREAD KEPT SEPARATING/BREAKING. ANOTHER SUTURE WAS USED BUT IT WOULD ALSO BREAK. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16808400 ↗
• MalfunctionMar 10, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE TEN SUTURES WERE BREAKING AT THE SWAGED PART.

  Patient problems: Insufficient Information

  MAUDE report 16525825 ↗
• MalfunctionFeb 8, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A BREAST AUGMENTATION PROCEDURE, THE SWAGED PART OF THE NEEDLE/THREAD KEPT SEPARATING/BREAKING. ANOTHER SUTURE WAS USED BUT IT WOULD ALSO BREAK. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16330376 ↗
• MalfunctionFeb 1, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN ABDOMINOPLASTY PROCEDURE, THE SWAGED PART OF THE NEEDLE/THREAD KEPT SEPARATING/BREAKING. ANOTHER SUTURE WAS USED, BUT IT WOULD ALSO BREAK. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16277864 ↗
• MalfunctionFeb 3, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC PROCEDURE, THE DEVICE NEEDLE BREAK OFF FROM THE THREAD. THE SURGEON THEN USED ANOTHER DEVICE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11272308 ↗
• MalfunctionNov 24, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PLASTIC SURGERY ON THE BREAST TISSUE, WHEN CLOSING, THE FOUR NEEDLES KEPT POPPING OFF THE STRAND WITH VERY LITTLE FORCE. IT OCCURRED WHILE THE SURGEON WAS USING AN INSTRUMENT BUT ALSO WHILE USING THE HANDS. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10896250 ↗
• InjuryMar 17, 2017Break; Detachment Of Device Component; Break; Detachment Of Device Component

  ACCORDING TO THE REPORTER; DURING A LAPAROSCOPIC PROCEDURE, THE NEEDLE OF THE SUTURE BROKE OFF AND AN X-RAY WAS UTILIZED TO SEARCH FOR THE FRAGMENT WHICH HAD FALLEN INTO THE FEMORAL ARTERY IN PROXIMITY OF THE VASCULAR SYSTEM AND RESULTING IN AN EXTENSION OF THE PROCEDURE BY AN HOUR. THE FRAGMENT WAS REMOVED FROM THE PATIENT AND NO DAMAGE WAS CAUSED BY THE FRAGMENT.

  Patient problems: Radiation Exposure, Unintended

  MAUDE report 6415506 ↗

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: