Maxon 8886 6217-31Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10884523002331), received between Feb 29, 2016 and Feb 26, 2026 — classified as 1 injury, 16 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (15 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 18, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 26, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A URETERAL ANASTOMOSIS, THE NEEDLES DETACHED FROM THE SUTURE THREAD WHILE SUTURING OR PREPARING THE SUTURE AFTER THE PATIENT INCISION. THE NEEDLE DID NOT FALL INTO THE PATIENT CAVITY. 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 24451909 ↗
• MalfunctionFeb 26, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A URETERAL ANASTOMOSIS, THE NEEDLES DETACHED FROM THE SUTURE THREAD WHILE SUTURING OR PREPARING THE SUTURE AFTER THE PATIENT INCISION. THE NEEDLE DID NOT FALL INTO THE PATIENT CAVITY. 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 24451902 ↗
• MalfunctionMay 1, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN UROLOGICAL PROCEDURE, AFTER REMOVING THE SUTURE AND USING ONE NEEDLE, THE CONNECTION BETWEEN THE NEEDLE AND THREAD BROKE. ANOTHER SUTURE WAS USED, BUT THE SAME ISSUE OCCURRED. A NEW SUTURE WAS THEN USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21946079 ↗
• MalfunctionJun 20, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO VETERINARY PROCEDURE, WHEN THE DEVICE WAS OPENED, THE SUTURE AND NEEDLE WERE DISCONNECTED. A NEW SUTURE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17162111 ↗
• MalfunctionDec 1, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE NEEDLE AND THREAD WAS BROKEN UPON OPENING. ANOTHER DEVICE WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12908262 ↗
• MalfunctionAug 22, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, IN THE ABDOMINAL CAVITY DURING A LAPAROSCOPIC UTERINE MYOMECTOMY, THE THREAD CAME OFF FROM THE PROXIMAL PART AND THE NEEDLE DISENGAGED FROM THE PATIENT CAVITY. AFTER SEARCHING UNDER THE ENDOSCOPE, IT WAS COLLECTED FROM THE TROCAR. THERE WAS NO PATIENT INJURY. THE SURGICAL PROCEDURE WAS EXTENDED FOR MORE THAN 30 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12352105 ↗
• MalfunctionApr 5, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE THREAD AND NEEDLE BROKE DURING SURGICAL PREPARATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11614268 ↗
• MalfunctionSep 18, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A COLECTOMY END TO END ANASTOMOSIS, THE FIRST PACKET, THE THREAD CONTINUED TO COME OFF FROM THE SWEDGE PART OF TWO SUTURES. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10552168 ↗
• MalfunctionJul 9, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN ANIMAL PROCEDURE, WHILE BEING USED IN CLOSING SURGICAL INCISION, WHEN OPENING THE PACKAGE, THE THREAD AND THE NEEDLE WERE NOTED TO BE DISENGAGED. THE EVENT OCCURRED DURING THE PROCEDURE BUT THE PRODUCT WAS NOT USED ON THE PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10250589 ↗
• MalfunctionApr 2, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE VETERINARY PROCEDURE, WHEN THE PRODUCT WAS OPENED (UNUSED), THE NEEDLE AND THE THREAD WERE FOUND TO BE DISENGAGED. THE EVENT OCCURRED DURING THE PROCEDURE, BUT THE PRODUCT WAS NOT USED FOR PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9915041 ↗
• MalfunctionFeb 20, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC RECTUM, WHEN OPENING THE PACKAGE, THE THREAD WAS FOUND TO BE BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE EVENT OCCURRED DURING THE PROCEDURE, BUT THE PRODUCT WAS NOT USED FOR PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9733916 ↗
• MalfunctionJan 9, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, NEEDLE AND THE THREAD WERE FOUND TO BE DISENGAGED. THE EVENT OCCURRED DURING THE PROCEDURE BUT THE PRODUCT WAS NOT USED FOR PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9571107 ↗
• MalfunctionJan 2, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE THREAD AND THE NEEDLE WERE FOUND TO BE DISCONNECTED WHEN THE PRODUCT WAS REMOVED FROM THE BAG. ANOTHER DEVICE WAS THEN USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9537819 ↗
• MalfunctionNov 22, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, WHEN THE NEEDLE AND THREAD WERE TRIED TO BE TAKEN OUT WITH NEEDLE FORCEPS, THE THREAD CAME OFF AND ONLY THE NEEDLE WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9364323 ↗
• MalfunctionSep 27, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING VETERINARY PROCEDURE, THE NEEDLE AND THREAD WERE FOUND TO BE DISENGAGED AT THE TIME OF OPENING. A NEW PRODUCT WAS OPENED AND USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9129147 ↗
• MalfunctionDec 3, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING ANASTOMOSIS ON AN OPEN PANCREATICODUODENECTOMY, THE NEEDLE GOT DETACHED FROM THE SUTURE WHEN THEY TOOK THE DEVICE OUT OF THE PACKAGE. IT WAS STATED THAT THE NEEDLE WAS NOT BROKEN INTO PIECES. THEY CHANGED THE SUTURE TO COMPLETE THE CASE. THERE IS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8124464 ↗
• InjuryFeb 29, 2016Detachment Of Device Component; Detachment Of Device Component; Device Or Device Fragments Location Unknown

  ACCORDING TO THE REPORTER: DURING THE EXTRACTION OF THE THREAD, THE NEEDLE DETACHED IN THE TROCAR AND WAS NOT FOUND. A INTRAOPERATIVE RADIOSCOPY WAS NEEDED.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 5466261 ↗

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: