Maxon 8886 6217-41Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 10884523002348), received between Mar 31, 2016 and Oct 29, 2025 — classified as 2 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (20 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 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 29, 2025Break; Break

  (HOLD FOR CP 10.31) IT WAS REPORTED THAT DURING AN OPEN BURN SURGERY, WHILE PERFORMING A SUBCUTANEOUS WOUND SUTURE USING A CONTINUOUS SUTURE TECHNIQUE, THE THREAD OF THE SUTURE BROKE THREE MINUTES INTO THE PROCEDURE. THE PROCEDURE WAS COMPLETED BY REPLACING THE PRODUCT WITH ONE FROM ANOTHER MANUFACTURER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23415762 ↗
• MalfunctionOct 15, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTROINTESTINAL PROCEDURE, IN INTESTINAL ANASTOMOSIS, THE THREAD BROKE WHEN IT WAS JUST TAKEN OUT OF THE PACKAGE. TO RESOLVE THE ISSUE, A NEW SUTURE FROM ANOTHER MANUFACTURER WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23296628 ↗
• MalfunctionNov 18, 2024Break; Product Quality Problem; Break; Product Quality Problem

  ACCORDING TO THE REPORTER, DURING THE PARTIAL KIDNEY RESECTION, THE THREAD HAS A DIFFERENT RIGIDITY AND THEREFORE APPARENTLY A DIFFERENT ELASTICITY THAN THE ORIGINAL. THE SUTURE TEARS FAR TOO QUICKLY UNDER STRAIN AND TENDS TO BREAK WHEN KNOTTING AND CLIPPING.

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

  MAUDE report 20706087 ↗
• MalfunctionNov 29, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE NEEDLE CAME OFF THE THREAD. ANOTHER SUTURE WAS USED IN ORDER TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12881859 ↗
• MalfunctionJul 7, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, WHILE USING THE DEVICE IMMEDIATELY AFTER OPENING FROM THE PACKAGE, TWO SUTURES HAD THE NEEDLE DETACHED FROM THE STRAND. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12130855 ↗
• MalfunctionJun 3, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, WHEN THE PRODUCT WAS OPENED FOR A CAT SPAY PROCEDURE, THE NEEDLE AND SUTURE WERE DISCONNECTED. THERE WAS NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11930087 ↗
• MalfunctionApr 28, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A VETERINARIAN PROCEDURE, THE THREAD HAD COME OFF WHEN THE NEEDLE WAS PULLED OUT OF THE TISSUE AFTER CONTINUOUS SUTURING. THE PRODUCT WAS NOT APPLIED ANY TENSION, BUT THE THREAD HAD COME OFF. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11739750 ↗
• MalfunctionMar 16, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO A PROCEDURE, UPON OPENING THE PACK, IT WAS NOTED THAT THE NEEDLE WAS DETACHED FROM THE THREAD. THIS HAPPENED TO FOUR PACKS OF THE SUTURE DEVICES. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11497113 ↗
• MalfunctionMar 3, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING VETERINARY SURGERY, THE THREAD BROKE. X-RAY WAS PERFORMED FOR THE EXPRESS PURPOSE OF CONFIRMING THAT ALL PIECES WERE LOCATED.

  Patient problems: Radiation Exposure, Unintended

  MAUDE report 9779726 ↗
• MalfunctionMar 1, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A VETERINARY CASE, WHEN THE PACKAGE WAS OPENED, THE NEEDLE AND THREAD WERE FOUND TO BE DISENGAGED AT THE UNUSED STAGE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9772710 ↗
• MalfunctionJan 2, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A VETERINARY PROCEDURE, WHEN THE SURGEON GOT THE PRODUCT OUT OF THE PACKAGE, THE NEEDLE CAME OFF. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9538964 ↗
• MalfunctionDec 3, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE INSIDE AN ANIMAL HOSPITAL, UPON OPENING THE DEVICE'S PACKET, THE NEEDLE AND THE THREAD WERE FOUND TO BE DISENGAGED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9407376 ↗
• MalfunctionNov 22, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A GENERAL STITCHING AT A VETERINARY PROCEDURE, NEEDLE BROKE OFF THE THREAD. SEVERAL UNITS FROM THE SAME LOT WERE AFFECTED. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9362544 ↗
• MalfunctionNov 14, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A GENERAL STITCHING AT A VETERINARY PROCEDURE, NEEDLE BROKE OFF THE THREAD. SEVERAL UNITS FROM THE SAME LOT WERE AFFECTED. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9324958 ↗
• MalfunctionNov 4, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC CHOLECYSTECTOMY, DURING ANASTOMOSIS, WHILE USING THE RUNNING STITCH TECHNIQUE, THE THREAD OF THE SUTURE BROKE AT THE POINT BETWEEN THE CONNECTING THREAD AND NEEDLE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9272998 ↗
• MalfunctionSep 23, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPY FOR ADHESIOLYSIS, BOWEL RESECTION, AND ANASTOMOSIS OF THE BOWEL, WHEN THE NURSE REMOVED THE DEVICE FROM ITS PACKING, THE SUTURE CAME AWAY FROM THE NEEDLE. ANOTHER DEVICE WAS USED, HOWEVER, THE SUTURE DETACHED FROM THE NEEDLE AS WELL AS SOON AS THE SURGEON USED IT.

  Patient problems: No Information

  MAUDE report 9107813 ↗
• InjurySep 23, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPY FOR THE FORMATION OF A LOOP ILEOSTOMY, WHILE TRYING TO SUTURE, THE NEEDLE CAME AWAY FROM THE SUTURE MATERIAL AND DISAPPEARED. IT WAS STATED THAT AN X-RAY PERFORMED TO LOCATE AND RETRIEVE THE NEEDLE FROM THE ABDOMINAL WALL ADDING OPERATING AND ANAESTHETIC TIME. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE.

  Patient problems: No Code Available; Radiation Exposure, Unintended

  MAUDE report 9107810 ↗
• MalfunctionFeb 26, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING WEDGE SEGMENTAL RESECTION, WHEN OPENING THE FIRST PACKET, THE NEEDLE AND THE THREAD WERE FOUND TO BE DISENGAGED, SO IT WAS UNABLE TO BE USED AND A NEW PRODUCT WAS USED. THE CASE WAS UNKNOWN BECAUSE THE EVENT OCCURRED IN AN ANIMAL HOSPITAL. THE EVENT OCCURRED DURING THE PROCEDURE, BUT THE PRODUCT WAS NOT USED FOR PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8370141 ↗
• MalfunctionJan 8, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, WHEN UNPACKING THE REPORTED PRODUCT TO USE, THE NEEDLE AND THE THREAD WERE FOUND TO BE DISCONNECTED THEREFORE COULD NOT BE USED. A NEW PRODUCT WAS OPENED AND IT WAS ABLE TO BE USED WITHOUT PROBLEMS. THE EVENT OCCURRED DURING THE PROCEDURE, BUT THE PRODUCT WAS NOT USED FOR PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8229830 ↗
• MalfunctionSep 13, 2018Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, POST OPERATIVELY, THE PATIENT HAD PALP CAUDAL WOUND HERNIA. THE SURGICAL WOUND WAS OPENED AND THE SUTURE HAS BROKEN AND THE KNOT WAS IN TACT. ALL PREVIOUS SUTURE MATERIALS FRESH EDGES HAVE BEEN REMOVED AND RE SUTURED LINES AND CLOSED THE SKIN. THE PATIENT WAS ON BED REST WITH BUSTER COLLAR AND WAS PROVIDED MEDICATION.

  Patient problems: Hernia; No Code Available

  MAUDE report 7872958 ↗
• MalfunctionJul 3, 2018Break; Detachment Of Device Component; Break; Detachment Of Device Component

  ACCORDING TO THE REPORTER, IN A GYNECOLOGY PROCEDURE, THE SUTURE BROKE WHILE KNOTTING. THE SECOND DEVICE WAS USED BUT THE NEEDLE BROKE WHILE INSERTING. THE PART FELL INTO THE PATIENT'S CAVITY AND WAS RETRIEVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7660145 ↗
• MalfunctionApr 26, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE NEEDLE WAS DETACHED FORM THE THREAD. THE STATUS OF THE PATIENT WAS FINE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7464850 ↗
• MalfunctionJan 26, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER: THE ISSUE OCCURRED DURING THE PROCEDURE. THE NEEDLE HAD COME OFF THE THREAD. IT WAS NOT USED TO THE PATIENT. THE SURGEON USED ANOTHER DEVICE TO COMPLETE THE CASE. THERE WAS NO PROBLEM WITH THE PATIENT'S CONDITION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7221074 ↗
• MalfunctionJan 18, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING BOWEL SURGERY LAPAROSCOPIC PROCEDURE, UPON KNOTTING OFF THE SUTURE, THE DEVICE THREAD BROKE AT THE END OF THE PROCEDURE. THE THREAD BROKE OF THE NEEDLE AT THE CONNECTION IT OF BOTH NEEDLE/THREAD. ALWAYS THE SAME PLACE. ANOTHER SUTURE WAS OPENED TO COMPLETE THE CASE. THERE WAS NOT PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7203847 ↗
• MalfunctionJan 18, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING BOWEL SURGERY LAPAROSCOPIC PROCEDURE, UPON KNOTTING OFF THE SUTURE, THE DEVICE THREAD BROKE AT THE END OF THE PROCEDURE. THE THREAD BROKE OF THE NEEDLE AT THE CONNECTION IT OF BOTH NEEDLE/THREAD. ALWAYS THE SAME PLACE. ANOTHER SUTURE WAS OPENED TO COMPLETE THE CASE. THE PATIENT WAS ALIVE WITH NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7203062 ↗

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: