Maxon 8886622131-2Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521757837), received between Nov 3, 2022 and Aug 22, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A VIDEO-ASSISTED THORACOSCOPIC SURGERY (VATS) RESECTION, PRIOR TO PATIENT USE, WHEN RETRACTING FROM THE RETAINER AND PREPARING FOR SUTURE, THE THREAD REGION OF THE THREE SUTURES WAS DAMAGED; THE NEEDLES CAME OFF THE THREADS AT THE STAGE OF REMOVING IT FROM THE PACKAGE A NEW SUTURE FROM ANOTHER COMPANY WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20027272 ↗
• MalfunctionAug 21, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A VIDEO-ASSISTED THORACOSCOPIC SURGERY (VATS) RESECTION, PRIOR TO PATIENT USE, WHEN RETRACTING FROM THE RETAINER AND PREPARING FOR SUTURE, THE THREAD REGION OF THE THREE SUTURES WAS DAMAGED; THE NEEDLES CAME OFF THE THREADS AT THE STAGE OF REMOVING IT FROM THE PACKAGE A NEW SUTURE FROM ANOTHER COMPANY WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20022681 ↗
• MalfunctionAug 21, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A VIDEO-ASSISTED THORACOSCOPIC SURGERY (VATS) RESECTION, PRIOR TO PATIENT USE, WHEN RETRACTING FROM THE RETAINER AND PREPARING FOR SUTURE, THE THREAD REGION OF THE THREE SUTURES WAS DAMAGED; THE NEEDLES CAME OFF THE THREADS AT THE STAGE OF REMOVING IT FROM THE PACKAGE A NEW SUTURE FROM ANOTHER COMPANY WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20018957 ↗
• MalfunctionNov 8, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SURGERY, WHEN THE NURSE TOOK OUT THE PACKET AND OPENED THE PACKAGE, THE SUTURE WAS NOT ATTACHED TO THE NEEDLE. ANOTHER PACKET OF THE SAME PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15754641 ↗
• MalfunctionNov 3, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO USE, WHILE PREPARING THE DEVICE, THE NEEDLE HAS COME OFF THE SUTURE WHEN THE PACKAGE WAS OPENED; ONE OF THE DOUBLE-ENDED NEEDLES HAD A SUTURE WHILE THE OTHER SIDE HAD NO SUTURE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15721595 ↗

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: