Maxon 8886 6618-41Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10884523004014), received between Jun 3, 2020 and Nov 13, 2024 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (18 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 13, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, AT THE MOMENT OF PASSING THE FIRST POINT, THE NEEDLE WAS DISASSEMBLED. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20675953 ↗
• MalfunctionJun 17, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, AFTER OPENING THE PACKAGE, IT TURNED OUT THAT THE THREAD WAS DETACHED FROM THE EIGHT NEEDLES. THE NEXT SUTURE WITH ANOTHER LOT NUMBER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19548968 ↗
• MalfunctionJun 17, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, AFTER OPENING THE PACKAGE, IT TURNED OUT THAT THE THREAD WAS DETACHED FROM THE EIGHT NEEDLES. THE NEXT SUTURE WITH ANOTHER LOT NUMBER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19548775 ↗
• MalfunctionJun 17, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, AFTER OPENING THE PACKAGE, IT TURNED OUT THAT THE THREAD WAS DETACHED FROM THE EIGHT NEEDLES. THE NEXT SUTURE WITH ANOTHER LOT NUMBER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19548575 ↗
• MalfunctionJun 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, AFTER OPENING THE PACKAGE, IT TURNED OUT THAT THE THREAD WAS DETACHED FROM THE EIGHT NEEDLES. THE NEXT SUTURE WITH ANOTHER LOT NUMBER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19544022 ↗
• MalfunctionJun 14, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, AFTER OPENING THE PACKAGE, IT TURNED OUT THAT THE THREAD WAS DETACHED FROM THE EIGHT NEEDLES. THE NEXT SUTURE WITH ANOTHER LOT NUMBER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19543216 ↗
• MalfunctionJun 14, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, AFTER OPENING THE PACKAGE, IT TURNED OUT THAT THE THREAD WAS DETACHED FROM THE EIGHT NEEDLES. THE NEXT SUTURE WITH ANOTHER LOT NUMBER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19540950 ↗
• MalfunctionJun 14, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, AFTER OPENING THE PACKAGE, IT TURNED OUT THAT THE THREAD WAS DETACHED FROM THE EIGHT NEEDLES. THE NEXT SUTURE WITH ANOTHER LOT NUMBER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19540873 ↗
• MalfunctionJul 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, BEFORE STARTING SUTURING, THE NEEDLE BROKE OFF THE THREAD. THE NEEDLE AND THREAD WERE NOT WELDED TOGETHER AND THE SUTURE WAS NOT USED. THREE SUTURES HAD THE ISSUE. THE SUTURES WERE NOT USED. ANOTHER BOX WITH DIFFERENT SUTURES WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17317944 ↗
• MalfunctionJun 30, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PREOPERATIVELY, THE ABSORBABLE SUTURE WAS NOT ATTACHED TO THE NEEDLE. ANOTHER SUTURE FROM THE SAME BATCH WAS OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17242969 ↗
• MalfunctionNov 30, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE NEEDLE DETACHED FROM THE STRAND.

  Patient problems: Insufficient Information

  MAUDE report 15886787 ↗
• MalfunctionNov 23, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE NEEDLE WAS DETACHED FROM THE STRAND. SOME NEEDLES WERE ALSO SEEN LAYING SEPARATE FROM THE STRAND IN THE PACKAGE. A NEW SUTURE FROM THE SAME BOX WAS USED 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 15859267 ↗
• MalfunctionOct 10, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, WHILE IN THE SCRUB TABLE, THE THREAD BROKE WHEN REMOVED FROM THE CONTAINER. THE THREAD SEPARATED FROM THE NEEDLE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO ISSUES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15570233 ↗
• MalfunctionJun 29, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A RADICAL PROSTATECTOMY WITH LYMPHADENECTOMY, THE NEEDLE CAME OFF THE THREAD WHEN THE PACKAGING WAS OPENED. A NEW SUTURE WAS OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14855920 ↗
• MalfunctionNov 17, 2021Break; Break

  ACCORDING TO THE REPORTER DURING AN OPEN MASTECTOMY/BILATERAL BREAST RECONSTRUCTION, WHILE USING RUNNING STITCH TECHNIQUE UPON CLOSING THE PROCEDURE, THE THREAD BROKE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 12828779 ↗
• MalfunctionApr 15, 2021Break; Break

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE STRAND BROKE WHEN BEING REMOVED FROM THE ENVELOPE. ANOTHER SUTURE WAS USED 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 11671900 ↗
• MalfunctionMar 4, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, AFTER OPENING THE PACKAGE, IT TURNED OUT THAT THE THREAD WAS DETACHED FROM THE EIGHT NEEDLES. THE NEXT SUTURE WITH ANOTHER LOT NUMBER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11413196 ↗
• MalfunctionFeb 22, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING THE REPORTER, PRE-OPERATIVELY, THE SUTURE'S ENVELOPE WAS OPENED AND WHEN THE PRODUCT WAS REMOVED, THE NEEDLE WAS DISASSEMBLED FROM THE STRAND. ANOTHER SUTURE UNIT OF THE SAME REFERENCES AND LOT WAS USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11361135 ↗
• MalfunctionNov 3, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE OPERATIVELY, THE NEEDLE WAS RELEASED, DETACHED FROM THE THREAD AND IT HAPPENED WITH FOUR IN A ROW. THE OPERATOR USED SUTURES FROM ANOTHER BOX TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10780395 ↗
• MalfunctionJun 3, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING WOUND CLOSURE AFTER SPAYING PROCEDURE, THE NEEDLE WAS DETACHED ONCE THE PACKAGE WAS OPENED. THE EVENT OCCURRED DURING THE PROCEDURE BUT WAS NOT USED TO THE PATIENT. SURGEON OPENED ANOTHER PACK OF SUTURE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10115570 ↗

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: