Maxon 8886 6213-21Recalls & reported problems

Summary

The FDA's MAUDE database contains 85 adverse event reports that list this exact device (DI 10884523002300), received between Jul 27, 2017 and Aug 28, 2026 — classified as 6 injuries, 79 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (48 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 85 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 28, 2026Break

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

  MAUDE report 50493399 ↗
• MalfunctionAug 28, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50493193 ↗
• MalfunctionJul 28, 2026

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50058658 ↗
• MalfunctionApr 27, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER INTRAOPERATIVELY, THE NEEDLE DETACHED FROM THE SUTURE AT THE CONNECTION POINT. THE SUTURE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24994411 ↗
• MalfunctionMar 19, 2026Break

  ACCORDING TO THE REPORTER, DURING A ROBOT-ASSISTED PANCREATICODUODENECTOMY (DA VINCI), EVEN THOUGH THE SUTURE IS SUPPOSED TO HAVE HIGH TENSILE STRENGTH, THE SUTURE BROKE ON THE PROXIMAL SIDE RELATIVE TO THE AREA CLAMPED BY THE NEEDLE HOLDER, AND FREQUENT BREAKAGE WAS ALSO OBSERVED AT THE LIGATION POINT DURING THE LIGATION OPERATION. THE ISSUE OCCURRED ON THREE SUTURES FROM THE SAME BOX AND TWO FROM A DIFFERENT KIND OF SUTURES. THE SURGERY WAS COMPLETED USING ANOTHER COMPANY'S PRODUCT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24637579 ↗
• MalfunctionMar 19, 2026Break

  ACCORDING TO THE REPORTER, DURING A ROBOT-ASSISTED PANCREATICODUODENECTOMY (DA VINCI), EVEN THOUGH THE SUTURE IS SUPPOSED TO HAVE HIGH TENSILE STRENGTH, THE SUTURE BROKE ON THE PROXIMAL SIDE RELATIVE TO THE AREA CLAMPED BY THE NEEDLE HOLDER, AND FREQUENT BREAKAGE WAS ALSO OBSERVED AT THE LIGATION POINT DURING THE LIGATION OPERATION. THE ISSUE OCCURRED ON THREE SUTURES FROM THE SAME BOX AND TWO FROM A DIFFERENT KIND OF SUTURES. THE SURGERY WAS COMPLETED USING ANOTHER COMPANY'S PRODUCT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24637564 ↗
• MalfunctionMar 19, 2026Break

  ACCORDING TO THE REPORTER, DURING A ROBOT-ASSISTED PANCREATICODUODENECTOMY (DA VINCI), EVEN THOUGH THE SUTURE IS SUPPOSED TO HAVE HIGH TENSILE STRENGTH, THE SUTURE BROKE ON THE PROXIMAL SIDE RELATIVE TO THE AREA CLAMPED BY THE NEEDLE HOLDER, AND FREQUENT BREAKAGE WAS ALSO OBSERVED AT THE LIGATION POINT DURING THE LIGATION OPERATION. THE ISSUE OCCURRED ON THREE SUTURES FROM THE SAME BOX AND TWO FROM A DIFFERENT KIND OF SUTURES. THE SURGERY WAS COMPLETED USING ANOTHER COMPANY'S PRODUCT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24637546 ↗
• MalfunctionDec 24, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SUTURE NEEDLE BROKE. TO RESOLVE THE ISSUE, THE SURGEON PERFORMED A RE-SUTURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888492 ↗
• MalfunctionDec 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PLASTIC SURGERY, WHEN SUTURING THE INCISION, THE SUTURE AND THREAD DETACHED. ADDITIONAL SUTURE WAS USED TO RESOLVE THE INJURY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23705286 ↗
• MalfunctionOct 29, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING AN EXCISION OF A LEFT ANKLE SKIN MASS LESION PROCEDURE, ON THE THIRD STITCH OF WOUND CLOSURE, THE NEEDLE BROKE. THE BROKEN NEEDLE WAS IMMEDIATELY REMOVED, AND INSPECTION CONFIRMED THAT THE BROKEN PARTS COULD BE REASSEMBLED COMPLETELY, WITH NO FRAGMENTS LEFT INSIDE THE BODY. TO COMPLETE THE CASE, A NEW SUTURE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23414533 ↗
• MalfunctionAug 27, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT UPON OPENING A FRESH SUTURE FROM THE PACKAGING, THE NEEDLE WAS FOUND DETACHED FROM THE SUTURE AND THE OTHER SUTURE WAS BROKEN. THERE WAS NO PATIENT INVOLVED.

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

  MAUDE report 22903112 ↗
• MalfunctionAug 19, 2025Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  ACCORDING TO THE REPORTER, DURING AN OPEN INCISION CLOSURE, WHILE PERFORMING A CONTINUOUS SUTURING TECHNIQUE, THE NEEDLE BROKE, BUT IT DID NOT FALL INTO THE PATIENT'S CAVITY. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 22840249 ↗
• MalfunctionJul 29, 2025Break; Break

  ACCORDING TO THE REPORTER DURING AN OPEN SCAR REPAIR, THE NEEDLE BROKE WHILE PERFORMING A CONTINUOUS SUTURING TECHNIQUE. THE BROKEN NEEDLE DID NOT FALL INTO THE CAVITY. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22641534 ↗
• MalfunctionJul 29, 2025Break; Break

  IT WAS REPORTED THAT DURING AN OPEN NOSE DEFORMITY CORRECTION PROCEDURE, THE NEEDLE BROKE WHILE BEING APPLIED TO THE NOSE. REPLACEMENT OF THE SUTURE WAS REQUIRED TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22641371 ↗
• MalfunctionJul 29, 2025Break; Break

  IT WAS REPORTED THAT DURING AN OPEN HEAD AND FACE COSMETIC SURGERY INVOLVING THE EYES, THE NEEDLE BROKE WHILE PERFORMING A CONTINUOUS SUTURE. THE SUTURE WAS REPLACED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22641366 ↗
• MalfunctionJul 24, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN INCISION CLOSURE, WHILE PERFORMING A CONTINUOUS SUTURING TECHNIQUE, THE NEEDLE BROKE, BUT IT DID NOT FALL INTO THE PATIENT'S CAVITY. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22597142 ↗
• MalfunctionJul 17, 2025Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  ACCORDING TO THE REPORTER, DURING A SCAR EXCISION PROCEDURE, WHILE ON THE PROCESS OF SUTURING THE WOUND, THE NEEDLE BROKE. NO BROKEN NEEDLE WAS FOUND IN THE PATIENT'S BODY. A NEW SUTURE WAS REPLACED TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22530167 ↗
• MalfunctionJul 16, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, AFTER THE SURGEON COMPLETELY REMOVED THE TUMOR, THE SUTURE NEEDLE SUDDENLY BROKE WHEN SUTURING THE DERMIS ABOUT THE 8TH STITCH. AFTER THE CIRCULATING NURSE AND THE SURGEON CHECKED AND CONFIRMED, THE TWO BROKEN NEEDLES WERE SENT OFF THE STAGE INTACT. DELAYING THE SURGERY.

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

  MAUDE report 22520163 ↗
• MalfunctionJul 9, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A COSMETIC EYE SURGERY, BOTH NEEDLE AND THREAD BROKE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22455862 ↗
• MalfunctionJul 3, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING THE OPEN SCAR REPAIR AFTER BURNS, WHEN APPLIED ON THE HAND, THE NEEDLE BROKE WHILE USING CONTINUOUS SUTURING TECHNIQUE. NO DEVICE COMPONENT FELL INTO THE PATIENT CAVITY. THE SUTURE WAS REPLACED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 22400889 ↗
• MalfunctionMay 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN THE MEDICAL STAFF USED THE ABSORBABLE 5-0 SUTURE FOR SUTURING, THE NEEDLE BROKE INTO THE PATIENT'S BODY. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE AND REMOVED THE BROKEN NEEDLE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22084788 ↗
• MalfunctionFeb 24, 2025Break; Break

  IT WAS REPORTED THAT WHILE REMOVING FROM THE PACKAGING, THE NEEDLE OF THE SUTURE BROKE IN TWO WHEN NOT UNDER PRESSURE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21449962 ↗
• MalfunctionFeb 4, 2025Break; Break

  ACCORDING TO THE REPORTER DURING A SKIN CLOSURE PROCEDURE, WHEN SUTURING THE SKIN, THE NEEDLE BROKE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21304289 ↗
• MalfunctionFeb 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THERE WAS A DETACHMENT OF NEEDLE AND THREAD. IT WAS NOTED THAT IT WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21292964 ↗
• MalfunctionJan 31, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THERE WAS A DETACHMENT OF NEEDLE AND THREAD.

  Patient problems: Insufficient Information

  MAUDE report 21287238 ↗

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: