Maxon 8886 6233-31Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10884523002416), received between Sep 18, 2017 and May 23, 2025 — classified as 1 injury, 21 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (17 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 23, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROTOMY WITH INTESTINAL ANASTOMOSIS PROCEDURE, THE SUTURE BROKE ON THE CONNECTION PART OF NEEDLE AND THREAD ON THE FIRST STITCH. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22079824 ↗
• MalfunctionFeb 4, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, IN A LAPAROTOMY, THE THREAD CAME LOOSE AND BROKE FROM THE NEEDLE DURING THE INTESTINAL ANASTOMOSIS. THE SURGEON USED A NEW SUTURE FROM THE SAME LOT AND CONTINUED THE OPERATION. T HERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21309670 ↗
• MalfunctionSep 15, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING CESAREAN SECTION, AT SUBCUTANEOUS SUTURE, THE NEEDLE PASSING THROUGH THE TISSUE WAS CLAMPED WITH A NEEDLE HOLDER AND WHEN PULLED, THE NEEDLE CAME OFF FROM THE THREAD. NO COMPONENT FELL INTO THE PATIENT. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17761180 ↗
• MalfunctionSep 6, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN CORONARY ARTERY BYPASS GRAFTING (CABG), THE THREAD CAME OFF FROM THE NEEDLE JUNCTION ABOUT FOUR TO FIVE TIMES. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17695045 ↗
• MalfunctionFeb 24, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN COLOSTOMY CLOSURE PROCEDURE, WHEN COLON ANASTOMOSIS, THE THREAD BROKE. IN ONE SUTURE, THE THREAD BROKE OUT OF THE NEEDLE AND FOR THE OTHER THREE, IT DID BREAK DURING KNOTTING WITH HANDS WITHOUT NEEDLE HOLDER. THE PROBLEM WAS AN INSTABLE SUTURE. NEEDLE ITSELF WAS OKAY. THE DEVICE HAD BEEN OPENED OR REMOVED FROM THE PACKAGING FOR 40 MINUTES. TO RESOLVE THE ISSUE, NEW SUTURE WAS USED AND WAS PUT IT TOGETHER WITH THE BROKEN ONE TO FINISH THE SUTURE LINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16436113 ↗
• MalfunctionFeb 24, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN COLOSTOMY CLOSURE PROCEDURE, WHEN COLON ANASTOMOSIS, THE THREAD BROKE. IN ONE SUTURE, THE THREAD BROKE OUT OF THE NEEDLE AND FOR THE OTHER THREE, IT DID BREAK DURING KNOTTING WITH HANDS WITHOUT NEEDLE HOLDER. THE PROBLEM WAS AN INSTABLE SUTURE. NEEDLE ITSELF WAS OKAY. THE DEVICE HAD BEEN OPENED OR REMOVED FROM THE PACKAGING FOR 40 MINUTES. TO RESOLVE THE ISSUE, NEW SUTURE WAS USED AND WAS PUT IT TOGETHER WITH THE BROKEN ONE TO FINISH THE SUTURE LINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16436032 ↗
• MalfunctionFeb 24, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN COLOSTOMY CLOSURE PROCEDURE, WHEN COLON ANASTOMOSIS, THE THREAD BROKE. IN ONE SUTURE, THE THREAD BROKE OUT OF THE NEEDLE AND FOR THE OTHER THREE, IT DID BREAK DURING KNOTTING WITH HANDS WITHOUT NEEDLE HOLDER. THE PROBLEM WAS AN INSTABLE SUTURE. NEEDLE ITSELF WAS OKAY. THE DEVICE HAD BEEN OPENED OR REMOVED FROM THE PACKAGING FOR 40 MINUTES. TO RESOLVE THE ISSUE, NEW SUTURE WAS USED AND WAS PUT IT TOGETHER WITH THE BROKEN ONE TO FINISH THE SUTURE LINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16435965 ↗
• MalfunctionOct 27, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN COLOSTOMY CLOSURE PROCEDURE, WHEN COLON ANASTOMOSIS, THE THREAD BROKE. IN ONE SUTURE, THE THREAD BROKE OUT OF THE NEEDLE AND FOR THE OTHER THREE, IT DID BREAK DURING KNOTTING WITH HANDS WITHOUT NEEDLE HOLDER. THE PROBLEM WAS AN INSTABLE SUTURE. NEEDLE ITSELF WAS OKAY. THE DEVICE HAD BEEN OPENED OR REMOVED FROM THE PACKAGING FOR 40 MINUTES. TO RESOLVE THE ISSUE, NEW SUTURE WAS USED AND WAS PUT IT TOGETHER WITH THE BROKEN ONE TO FINISH THE SUTURE LINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15683313 ↗
• MalfunctionAug 5, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN PLASTIC PROCEDURE, THE SUTURE COMES OFF THE NEEDLE AS IT PASSED THROUGH THE TISSUE. THE SURGEON USED ANOTHER SUTURE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15180122 ↗
• MalfunctionSep 14, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE 72 NEEDLES DETACHED FROM THE THREAD. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12471869 ↗
• MalfunctionMar 3, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING PARTIAL MASTECTOMY, WHEN PERFORMING A SUBCUTANEOUS SUTURE, THE THREAD BROKE WHEN PULLING THE THREAD THROUGH THE NEEDLE AND HOLDING THE THREAD ATTEMPTING TO TIE IT FOR THE FIRST TIME. IT WAS TRIED FOR SEVERAL TIMES, BUT THE SITUATION WAS NOT IMPROVED. ANOTHER PACKAGE WAS OPENED AND USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11405019 ↗
• MalfunctionMar 2, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN SUTURING THE ANASTOMOSIS, AFTER SEVERAL STITCH, THE PRODUCT WAS LEFT WITH THE NEEDLE WAS FOUND CAME OFF THE THREAD. A NEW PRODUCT WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11400719 ↗
• MalfunctionDec 30, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN ABDOMINAL SURGERY, THE NEEDLE CAME OFF. A NEW PRODUCT WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11096693 ↗
• MalfunctionOct 31, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A GASTRECTOMY PROCEDURE, THE NEEDLE AND SUTURE WERE FOUND TO BE SEPARATED ONCE THE PACKAGE WAS OPENED. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE AND COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 10767547 ↗
• MalfunctionOct 6, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROXIMAL PANCREATICODUODENECTOMY PROCEDURE, THE NEEDLE CAME OFF WITH A LIGHT RESISTANCE. A NEW SUTURE WITH THE SAME LOT NUMBER WAS USED BUT THE SAME ISSUE OCCURRED. A THIRD SUTURE WAS USED TO RESOLVE THE ISSUE AND COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10633944 ↗
• MalfunctionAug 17, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, WHEN THE PRODUCT WAS OPENED DURING SUB TOTAL GASTRECTOMY, WHEN THE NEEDLE WAS GRASPED AND TRIED TO BE PULLED OUT, THE THREAD AND THE NEEDLE WERE DISENGAGED AND THE SURGEON STOPPED USING THE DEVICE. 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 10413692 ↗
• MalfunctionApr 14, 2020Break; Break

  ACCORDING TO THE REPORTER, ON A PROCEDURE, WHILE PERFORMING LIGATION DURING CLOSURE, THE THREAD BROKE SEVERAL TIMES. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9960993 ↗
• MalfunctionApr 4, 2019Break; Break

  ACCORDING TO THE REPORTER, POST OPERATIVELY, THE THIRTY SIX THREADS KEPT BREAKING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8482362 ↗
• MalfunctionDec 28, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN WHIPPLE PROCEDURE, ON THE FIRST STEP USING THE SINGLE STITCH TECHNIQUE, THE THREAD OF THE SUTURE BROKE WHEN IT WAS PULLED. ANOTHER SUTURE FROM A NEW LOT WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8202437 ↗
• InjurySep 5, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROXIMAL PANCREATICODUODENECTOMY, WHILE THE DEVICE WAS USED FOR ANASTOMOSIS OF THE BILE DUCT AND ANASTOMOSIS OF JEJUNUM, THE DEVICE, NEEDLE WAS DETACHED FROM THE THREAD, TO RESOLVE THE ISSUE THE SURGEON REPEATED THE ANASTOMOSES AND USED ANOTHER DEVICE TO COMPLETE THE CASE. THE SURGICAL TIME WAS EXTENDED MORE THAN 30 MINUTES AND THERE WAS A TISSUE DAMAGE DUE TO THE DEVICE PROBLEM.

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 7847613 ↗
• MalfunctionJan 4, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, BOTH THE NEEDLE AND THREAD OF AN ABSORBABLE SUTURE BROKE BEFORE BEING USED BY THE SURGEON. ANOTHER SUTURE WAS USED FROM THE PACKAGE TO COMPLETE THE CASE. THE PATIENT HAS NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7165073 ↗
• MalfunctionSep 18, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE NEEDLE DISENGAGED FROM THE SUTURE BUT DID NOT FALL INTO THE PATIENT'S CAVITY. THE DEVICE WAS DISCARDED BY THE CUSTOMER. THE EVENT OCCURRED DURING THE PROCEDURE BUT THE PRODUCT WAS NOT USED ON THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE STATUS OF THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6872413 ↗

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: