Maxon CV 8886 6124-11Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10884523001761), received between May 1, 2017 and Mar 7, 2025 — classified as 3 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (16 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.

• InjuryMar 7, 2025Break; Break

  ACCORDING TO THE REPORTER, IN A CAESAREAN SECTION, DURING INTRADERMAL SUTURING OF THE ABDOMINAL SKIN LAYER, WHEN THE LAST STITCH AT THE TOP OF THE INCISION ENTERED THE TISSUE, THE SURGEON FELT THAT THE SUTURING WAS ABNORMAL. THE NEEDLE HAD NO SENSE OF DIRECTION. THE NEEDLE WAS IMMEDIATELY WITHDRAWN, AND IT WAS FOUND THAT THE NEEDLE WAS MISSING 2/3 OF ITS BODY, WHICH WAS THE NEEDLE TIP. THE SURGEON IMMEDIATELY STOPPED SUTURING AND SEARCHED FOR THE TIP. THE SURGEON REMOVED SOME OF THE SUTURES FROM THE INCISION AND SEARCHED THE SURROUNDING DERMIS AND FAT LAYER BUT FAILED TO FIND THE TIP. A MAGNET WAS THEN USED TO SEARCH THE SURGICAL AREA AND THE TABLE SEVERAL TIMES, BUT THE TIP COULD STILL NOT BE FOUND. THE IMAGING DEPARTMENT WAS THEN CONTACTED TO TAKE AN X-RAY TO CONFIRM THAT THERE WAS NOTHING ABNORMAL IN THE PATIENT'S BODY. AFTER CONFIRMATION BY THE IMAGING DEPARTMENT, NO ABNORMALITIES WERE FOUND IN THE PATIENT'S BODY. THE MISSING TIP COULD NOT BE FOUND AFTER MULTIPLE SEARCHES.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 21547366 ↗
• MalfunctionDec 4, 2023Break; Material Deformation; Break; Material Deformation

  ACCORDING TO THE REPORTER, DURING A PRESENTATION, WHEN THE SINGLE PACKAGE OF SUTURE WAS OPENED, THE SUTURE COMES OUT ALREADY KNOTTED NEAR THE PLEDGETS. THE SAME ISSUE OCCURRED WITH THE SECOND SUTURE ALTHOUGH DUE TO THE KNOT, THE THREAD OF THE SECOND SUTURE ALSO BROKE DURING EXTRACTION. NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18257960 ↗
• MalfunctionAug 17, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE NEEDLE AND THREAD WERE DETACHED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17566325 ↗
• MalfunctionDec 27, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE HAD BROKE DURING THE SKIN SUTURING PROCESS. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16052679 ↗
• MalfunctionDec 7, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN EAR TUMOR RESECTION, WHEN THE EAR MASS EXCISION WAS PERFORMED AND SUTURED THE SKIN THE PACKAGE OF THE ABSORBABLE SUTURE WAS OPENED. IT WAS FOUND THAT THE SUTURE WAS NOT CONNECTED TO THE NEEDLE. THE SUTURE AND THE NEEDLE WERE DISCONNECTED AND COULD NOT BE USED. REPLACED ANOTHER ONE 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 15936834 ↗
• MalfunctionNov 2, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, AFTER UNPACKING, IT WAS FOUND THAT THE NEEDLE AND SUTURE DETACHED. ANOTHER PACK OF SUTURE OF WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15715075 ↗
• MalfunctionApr 27, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING INDIRECT INGUINAL HERNIA REPAIR, WHEN PREPARING THE SUTURE, THE NEEDLE AND THREAD WERE FOUND DETACHED. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE.

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

  MAUDE report 14220565 ↗
• MalfunctionFeb 3, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE SUTURE AND NEEDLE WERE FOUND TO BE DETACHED ON THREE PACKS OF THE SAME MODEL WHEN UNPACKING. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT AN ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13442970 ↗
• MalfunctionDec 1, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER PRIOR TO USE, AFTER UNPACKING IT WAS FOUND THAT THE NEEDLE AND SUTURE DETACHED. A NEW SUTURE WAS USED TO FIX THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12909887 ↗
• MalfunctionNov 17, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, WHEN UNPACKING THE PACKAGE BEFORE THE OPERATION, IT WAS FOUND THAT THE NEEDLE AND SUTURE WERE DETACHED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12828349 ↗
• MalfunctionAug 12, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PREOPERATIVELY, WHEN OPENING THE PACKAGE AND ATTEMPTING TO GRASP THE NEEDLE, THE NEEDLE WAS FOUND DETACHED FROM THE THREAD. A FEW PACKETS OF THE STOCK PRODUCT WERE OPENED AND CLINICALLY USED THE PRODUCT THAT COULD BE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12314255 ↗
• MalfunctionJun 9, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, WHEN PERFORMING MASS RESECTION OF RIGHT THIGH, FOREHEAD AND LEFT SHOULDER, THE SURGEON SUTURED THE SOFT TISSUE AFTER REMOVING THE FOREHEAD. WHEN THE FIRST STITCH WAS SUTURED, THE NEEDLE TIP BROKE IN THE SOFT TISSUE AND BROKEN NEEDLE WAS SEARCHED IN THE TISSUE IMMEDIATELY. IT TOOK ABOUT 10 MINUTES TO FIND THE BROKEN NEEDLE. THE OPERATION CONTINUED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11966618 ↗
• InjuryMar 3, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING CONCEALED PENIS LENGTHENING, WHEN SUTURING THE FORESKIN, THE NEEDLE BROKE. AN X-RAY WAS PERFORMED TO LOCATE THE BROKEN NEEDLE. THE SURGICAL TIME WAS EXTENDED 30 MINUTES OR MORE DUE TO THE PRODUCT PROBLEM.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 11404570 ↗
• MalfunctionSep 8, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING CIRCUMCISION PROCEDURE, THE DEVICE NEEDLE FOUND DETACHED FROM THE THREAD. THE SURGEON THEN OPENED ANOTHER PACK OF SUTURE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10501804 ↗
• MalfunctionSep 8, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A CIRCUMCISION PROCEDURE, THE MEDICAL STAFF OPENED A PACKAGE OF SUTURE AND WHEN THE NEEDLE HOLDER CLAMPED ONE THIRD OF THE NEEDLE TAIL TO EXTRACT IT, THE NEEDLE AND SUTURE WERE FOUND DETACHED. THE DEVICE IS A DOUBLE NEEDLE SUTUREAND IT WAS NOTED THAT BOTH NEEDLE WERE DETACHED. THE DEVICE WAS SEALED AND DISCARDED. ANOTHER SUTURE WITH THE SAME LOT NUMBER 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 10500843 ↗
• MalfunctionAug 31, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A URETHROPLASTY, THE SUTURE AND THE NEEDLE WERE FOUND DETACHED WHEN UNPACKING. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10472030 ↗
• MalfunctionJun 1, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, WHILE OPENING THE PACKAGE PRIOR TO USE, THE PACKAGING WAS UNPACKED, AND THE NEEDLE AND THREAD WERE FOUND DETACHED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10104368 ↗
• MalfunctionDec 27, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING EMERGENCY APPENDECTOMY, THE NEEDLE BROKE DURING SKIN SEWING. THE NURSE LOOKED FOR THE BROKEN STUMP AND PIECED TOGETHER. A NEW SUTURE WAS USED TO COMPLETE THE CASE. SURGICAL TIME WAS DELAYED DUE TO EVENT.

  Patient problems: No Information

  MAUDE report 9527794 ↗
• MalfunctionDec 13, 2019Break; Packaging Problem; Break; Packaging Problem

  ACCORDING TO THE REPORTER, PRE OPERATIVELY, THE SUTURE WAS NOT COMPLETELY COVERED IN THE OUTER PACKAGING, AND PART OF THE SUTURE WAS OUTSIDE THE PACKAGING. IT WAS ALSO REPORTED THAT THE SUTURE THREAD BROKE AND THE SURGEON BELIEVED THAT THE PROBLEM WAS PACKAGING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9463760 ↗
• MalfunctionSep 28, 2018Component Missing; Component Missing

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, BEFORE USING THE PRODUCT, WHEN THE ALUMINUM PACK WAS OPENED, THERE WERE NO CONTENTS CONTAINED. THEY THEN USED A NEW PRODUCT TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7918071 ↗
• MalfunctionAug 20, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING PROXIMAL PANCREATICODUODENECTOMY, WHEN THE SURGEON GRASPED THE NEEDLE WITH A NEEDLE HOLDER, THE NEEDLE BROKE OFF. 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 Known Impact Or Consequence To Patient

  MAUDE report 7797380 ↗
• MalfunctionNov 17, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER: BOTH THE NEEDLE AND THE THREAD OF THE SUTURE BROKE. THE SUTURE COMES OFF THE NEEDLE WHEN OPENED. NOTHING FALL INTO PATIENT CAVITY AND THERE WAS NO IMPACT TO THE PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7041468 ↗
• InjuryAug 14, 2017Break; Detachment Of Device Component; Break; Detachment Of Device Component

  ACCORDING TO THE REPORTER, DURING THE ANASTOMOSIS OF THE PANCREATIC DUCT IN A PROXIMAL PANCREATICODUODENECTOMY (WHIPPLE) PROCEDURE, THE TIP OF NEEDLE BROKE OFF AND FELL INTO THE PANCREATIC DUCT. THE PANCREATIC DUCT WAS ADDITIONALLY EXCISED TO FIND THE BROKEN NEEDLE TIP AND THE PIECE WAS RETRIEVED SUCCESSFULLY. THE PANCREATIC DUCT WAS AGAIN ANASTOMOSED USING A NEW PRODUCT. THE SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MINUTES. THERE WAS TISSUE DAMAGE AND TISSUE LOSS. THE INCISION WAS EXTENDED BY LESS THAN 3 CM. PATIENT IS UNDER OBSERVATION.

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 6791347 ↗
• MalfunctionMay 1, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER: OCCURRED DURING THE PROCEDURE, BUT WAS NOT USED ON A PATIENT. UPON OPENING THE PACKAGE, THE NEEDLE WAS DISCOVERED TO BE DISENGAGED FROM THE SUTURE THREAD. ANOTHER SUTURE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY OR EXTENSION IN SURGICAL TIME. PATIENT STATUS IS NO PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6533745 ↗

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: