Maxon CV 8886 6124-21Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10884523002072), received between Jul 7, 2017 and May 15, 2026 — classified as 6 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Break” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2026Detachment of Device or Device Component; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, WHILE PERFORMING DEBRIDEMENT AND SUTURING WITH AN ABSORBABLE SUTURE, THE CHILD HAD POOR COOPERATION AND THE SUTURE NEEDLE WAS SUBJECTED TO SIGNIFICANT EXTERNAL FORCE. THE PHYSICIAN FOUND THAT THE NEEDLE HAD FRACTURED. THE BROKEN NEEDLE WAS PROMPTLY LOCATED IN ITS ENTIRETY. THE DEPARTMENT THEN USED ANOTHER SUTURE OF THE SAME MODEL TO COMPLETE THE DEBRIDEMENT AND SUTURING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25188833 ↗
• MalfunctionApr 16, 2026Break

  ACCORDING TO THE REPORTER, DURING A EMERGENCY TRAUMA SUTURING, THE NEEDLE BROKE. ANOTHER SUTURE FROM ANOTHER MANUFACTURER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24896915 ↗
• MalfunctionMar 5, 2026Break

  IT WAS REPORTED THAT DURING A PEDIATRIC URETERAL RECONSTRUCTION SURGERY, THE NEEDLE COMPONENT OF THE DEVICE BROKE. THE BROKEN NEEDLE WAS REMOVED LAPAROSCOPICALLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24523795 ↗
• MalfunctionMar 4, 2026Break

  IT WAS REPORTED THAT DURING A PEDIATRIC URETERAL SUTURE LAPAROSCOPIC PROCEDURE, DURING THE SUTURING OF THE URETER, THE NEEDLE COMPONENT OF THE DEVICE BROKE. IT OCCURRED ON FOUR DEVICES. THE ISSUE WAS RESOLVED BY REPLACING THE SUTURE WITH A NEW ONE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24506043 ↗
• MalfunctionMar 4, 2026Break

  IT WAS REPORTED THAT DURING A PEDIATRIC URETERAL SUTURE LAPAROSCOPIC PROCEDURE, DURING THE SUTURING OF THE URETER, THE NEEDLE COMPONENT OF THE DEVICE BROKE. IT OCCURRED ON FOUR DEVICES. THE ISSUE WAS RESOLVED BY REPLACING THE SUTURE WITH A NEW ONE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24506039 ↗
• MalfunctionMar 4, 2026Break

  IT WAS REPORTED THAT DURING A PEDIATRIC URETERAL SUTURE LAPAROSCOPIC PROCEDURE, DURING THE SUTURING OF THE URETER, THE NEEDLE COMPONENT OF THE DEVICE BROKE. IT OCCURRED ON FOUR DEVICES. THE ISSUE WAS RESOLVED BY REPLACING THE SUTURE WITH A NEW ONE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24506033 ↗
• MalfunctionMar 4, 2026Break

  IT WAS REPORTED THAT DURING A PEDIATRIC URETERAL SUTURE LAPAROSCOPIC PROCEDURE, DURING THE SUTURING OF THE URETER, THE NEEDLE COMPONENT OF THE DEVICE BROKE. IT OCCURRED ON FOUR DEVICES. THE ISSUE WAS RESOLVED BY REPLACING THE SUTURE WITH A NEW ONE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24506032 ↗
• MalfunctionFeb 12, 2026Break

  ACCORDING TO THE REPORTER, WHILE PERFORMING DEBRIDEMENT AND SUTURING WITH AN ABSORBABLE SUTURE, THE CHILD HAD POOR COOPERATION AND THE SUTURE NEEDLE WAS SUBJECTED TO SIGNIFICANT EXTERNAL FORCE. THE PHYSICIAN FOUND THAT THE NEEDLE HAD FRACTURED. THE BROKEN NEEDLE WAS PROMPTLY LOCATED IN ITS ENTIRETY. THE DEPARTMENT THEN USED ANOTHER SUTURE OF THE SAME MODEL TO COMPLETE THE DEBRIDEMENT AND SUTURING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24323650 ↗
• InjuryFeb 10, 2026Break

  IT WAS REPORTED THAT DURING THYROID SURGERY, DURING SUBCUTANEOUS TISSUE SUTURING, THE NEEDLE BREAKAGE OCCURRED. THE NEEDLE TIP COULD NOT BE LOCATED AFTER PUNCTURE, AND THE SURGICAL TIME WAS EXTENDED BY MORE THAN 1 HOUR. AN X-RAY WAS PERFORMED TO LOCATE THE NEEDLE.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 24307270 ↗
• MalfunctionJan 30, 2026Break

  IT WAS REPORTED THAT DURING A PEDIATRIC CIRCUMCISION, WHILE PERFORMING SKIN SUTURING VIA CONTINUOUS SUTURING TECHNIQUE, THE NEEDLE BROKE. A NEW SUTURE WAS USED TO COMPLETE THE STITCHING. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24221715 ↗
• MalfunctionDec 3, 2025Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE NEEDLE BROKE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23706556 ↗
• MalfunctionNov 24, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A LEFT BREAST SEGMENTAL RESECTION AND FASCIAL TISSUE FLAP RECONSTRUCTION, THE NEEDLE BROKE INTO TWO PIECES. THE RESOLUTION INVOLVED IMMEDIATELY REMOVING THE NEEDLE TIP THAT REMAINED UNDER THE SKIN AND IT WAS CONFIRMED TO BE INTACT AND NO FRAGMENTS WERE RETAINED. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23638231 ↗
• MalfunctionSep 9, 2025Break; Break

  ACCORDING TO THE REPORTER DURING AN OPEN FINGER INJURY WITH NAIL DAMAGE, SHORTLY AFTER STARTING THE SUTURING PROCESS, AFTER JUST ONE STITCH THE SUTURE NEEDLE BROKE. WITH PART OF THE METAL NEEDLE REMAINING INSIDE THE TISSUE. THE DOCTOR IMMEDIATELY HANDLED THE SITUATION, SUCCESSFULLY LOCATING AND REMOVING THE BROKEN NEEDLE. THE SUTURING OPERATION TIME WAS EXTENDED APPROXIMATELY 8 MINUTES. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE.

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

  MAUDE report 23005653 ↗
• InjuryOct 15, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE NEEDLE BROKE AND FELL INTO PATIENT'S CAVITY DURING IMPLANTATION. IN ORDER TO FIND THE BROKEN NEEDLE, THE SURGERY WAS CONVERTED INTO OPEN SURGERY.

  Patient problems: Laceration(s)

  MAUDE report 20450610 ↗
• InjuryMay 23, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A RIGHT URETERAL REIMPLANTATION PROCEDURE, WHEN THE SURGEON USED THE SUTURE TO FIX THE END OF THE URETER TO THE SIDE WALL OF THE LEFT URETER, THE SUTURE NEEDLE BROKE AND 2/3 OF IT WAS BURIED IN THE TISSUE, INVISIBLE TO THE NAKED EYE. UNDER C-ARM MACHINE FLUOROSCOPY, THE STUMP OF THE SUTURE NEEDLE WAS VISIBLE IN THE LOWER LEFT ABDOMEN. AN ELECTRIC HOOK WAS USED TO INCISE THE SIDE WALL OF THE LOCAL BLADDER TO SEARCH FOR THE STUMP OF THE SUTURE NEEDLE LAYER BY LAYER, BUT THE ATTEMPT FAILED. THE SEARCH CONTINUED AFTER THE URETERAL REIMPLANTATION WAS COMPLETED. LAPAROSCOPY WAS USED TO SEARCH IN THE ABDOMINAL CAVITY. AT THE SAME TIME, THE C-ARM MACHINE SEARCHED AGAIN, BUT STILL FAILED. A LAPAROTOMY WAS PERFORMED TO EXPLORE. THE PATIENT'S VITAL SIGNS WERE UNSTABLE, AND THE SURGEON, ANESTHESIOLOGIST, SURGERY CENTER, AND MEDICAL EDUCATION DEPARTMENT JOINTLY DECIDED TO CLOSE THE ABDOMEN. THE SURGICAL TIME WAS EXTENDED DUE TO THE DEVICE PROBLEM. FIVE DAYS AFTER THE PROCEDURE, THE BROKEN NEEDLE WAS REMOVED BY SURGERY.

  Patient problems: Foreign Body In Patient; Laceration(s); Tissue Breakdown; Unintended Radiation Exposure

  MAUDE report 19385653 ↗
• MalfunctionApr 21, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC HIGH LIGATION OF THE BILATERAL PROCESSUS VAGINALIS, AT NEEDLE EXTRACTION AFTER USING TO FIX THE ROOT OF THE TESTIS AND THE SARCOLEMMA, THE NEEDLE AND THREAD DETACHED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16791186 ↗
• InjuryJul 25, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING ANASTOMOSIS OF URETER, THE SUTURE BROKE. 2 ADDITIONAL SUTURES HAD TO BE USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THIS RESULTED TO INCREASED MANIPULATION AND TRAUMA TO URETER. ANESTHESIA TIME WAS EXTENDED BY ONE HOUR.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12222989 ↗
• InjuryMar 12, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE OPERATION WENT SMOOTHLY DURING A CONCEALED PENIS LENGTHENING PROCEDURE. THE PATIENT THEN USED A SYNTHETIC ABSORBABLE SURGICAL SUTURE TO SUTURE THE SKIN BUT HALF OF THE NEEDLE BROKE IN THE SKIN. THE BROKEN NEEDLE WAS DIFFICULT TO BE FOUND IN THE SKIN SO AN X-RAY WAS TAKEN. AFTER THE LOCATION WAS DETERMINED, THE BROKEN NEEDLE WAS FOUND AND REMOVED. THE OPERATION WAS THEN CONTINUED. IT WAS STATED THAT SURGICAL TIME WAS EXTENDED SINE IT TOOK ABOUT 50 MINUTES FROM THE BREAKING OF THE NEEDLE TO THE REMOVAL OF IT.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 11477310 ↗
• MalfunctionJul 24, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PANCREATICODUODENECTOMY (WHIPPLE) PROCEDURE, THE SURGEON USES UP TO 12 SUTURES FOR THE ANASTOMOSIS, AND ONE NEEDLE CAME OFF THE THREAD AS THE TECHNICIAN WAS HANDING THE SUTURE TO THE SURGEON. ANOTHER SUTURE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10323684 ↗
• MalfunctionJun 11, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PENILE LENGTHENING DUE TO CONCEALED PENIS, THE MEDICAL PERSONNEL OPENED A PACKAGE AND FOUND THAT THE NEEDLE AND THREAD WERE DETACHED. THEY REPLACED THE PRODUCTS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10142349 ↗
• MalfunctionFeb 5, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE SUTURE AND THE NEEDLE WERE FOUND DETACHED WHEN UNPACKING. AFTER CAREFUL INSPECTION OF THE PRODUCT, IT WAS FOUND THAT THE SUTURE WAS BROKEN. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9670417 ↗
• MalfunctionJan 6, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING SKIN CLOSURE IN A RHINOPLASTY PROCEDURE, THE NEEDLE DETACHED FROM THREAD. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9552647 ↗
• MalfunctionSep 26, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING A LAPAROSCOPIC UROLOGICAL PROCEDURE, AT THE END OF THE CASE IN THE MOMENT OF ANASTOMOSIS, BOTH THE THREAD AND THE NEEDLE OF THE DEVICE BROKE FOR 5 OF THE DEVICES WITH THE SAME LOT NO. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9125211 ↗
• InjuryJul 7, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, DURING AN OPEN WHIPPLE PROCEDURE, THE DEVICE WAS DIFFICULT TO USE. THE SURGEON STATED SPECIFICALLY WHEN PULLING THE SUTURE THROUGH THE PANCREATIC DUCT, THE SUTURE PULLED LESS SMOOTHLY AND WAS STICKIER. THE SURGEON WAS ABLE TO COMPLETE THE CASE WITH NO ISSUE DESPITE THIS CONCERN THAT THE SUTURE WAS DRAGGING. NO PATIENT INJURY HAS BEEN NOTED. THE PATIENT IS IN THE ICU WITH A PANCREATIC LEAK ATTRIBUTED TO THE SUTURE, BECAUSE OF THE WAY IT PULLS TISSUE AND DOES NOT GLIDE AS EASILY. THE PATIENT HAS NOT HAD A REOPERATION. THE PATIENT IS IN THE ICU AND IS INTUBATED WITH HAVING GONE THROUGH DRAINS.

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

  MAUDE report 6692647 ↗

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: