Maxon 8886 6641-41Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10884523004151), received between Mar 8, 2018 and Jun 25, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Unraveled Material” (7 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2026Unraveled Material

  ACCORDING TO THE VETERINARY REPORT, THE DOCTOR USED 10 SUTURES SO FAR AND HAD FOUR REACTIONS FROM IT. 72 HOURS POST SURGERY, THE SUTURE WAS INTACT BUT THE TENSION WAS GONE AND DID NOT HOLD THE SKIN TOGETHER.

  Patient problems: Insufficient Information

  MAUDE report 25618985 ↗
• MalfunctionJun 25, 2026Unraveled Material

  ACCORDING TO THE VETERINARY REPORT, THE DOCTOR USED 10 SUTURES SO FAR AND HAD FOUR REACTIONS FROM IT. 72 HOURS POST SURGERY, THE SUTURE WAS INTACT BUT THE TENSION WAS GONE AND DID NOT HOLD THE SKIN TOGETHER.

  Patient problems: Insufficient Information

  MAUDE report 25618499 ↗
• MalfunctionJun 25, 2026Unraveled Material

  ACCORDING TO THE VETERINARY REPORT, THE DOCTOR USED 10 SUTURES SO FAR AND HAD FOUR REACTIONS FROM IT. 72 HOURS POST SURGERY, THE SUTURE WAS INTACT BUT THE TENSION WAS GONE AND DID NOT HOLD THE SKIN TOGETHER.

  Patient problems: Insufficient Information

  MAUDE report 25618489 ↗
• MalfunctionJun 25, 2026Unraveled Material

  ACCORDING TO THE VETERINARY REPORT, THE DOCTOR USED 10 SUTURES SO FAR AND HAD FOUR REACTIONS FROM IT. 72 HOURS POST SURGERY, THE SUTURE WAS INTACT BUT THE TENSION WAS GONE AND DID NOT HOLD THE SKIN TOGETHER.

  Patient problems: Insufficient Information

  MAUDE report 25618466 ↗
• MalfunctionNov 12, 2025Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, A DAY AFTER A VETERINARY ROUTINE SPAY PROCEDURE, THE SURGICAL SITE OPENED. THIS RESULTED IN HOSPITALIZATION TO REPAIR THE INCISIONS.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23532424 ↗
• MalfunctionNov 11, 2025Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, A DAY AFTER A VETERINARY ROUTINE SPAY PROCEDURE, THE SURGICAL SITE OPENED. THIS RESULTED IN HOSPITALIZATION TO REPAIR THE INCISIONS.

  Patient problems: Tissue Breakdown

  MAUDE report 23528295 ↗
• MalfunctionNov 11, 2025Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, ONE DAY POST-OPERATIVE OF A VETERINARY SPAY PROCEDURE FOR A CANINE PATIENT PERFORMED ON (B)(6) 2025, THE SURGICAL SITE OPENED. THE CANINE PATIENT WAS HOSPITALIZED FOR THE INCISION SITE REPAIR.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23523508 ↗
• MalfunctionFeb 19, 2024Component Missing; Component Missing

  ACCORDING TO THE REPORTER, PREOPERATIVE TO THE VETERINARY PROCEDURE, WHEN THE PACKAGE WAS OPENED, IT CONTAINED ONLY THREAD, AND THE NEEDLE WAS NOT PRESENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18735908 ↗
• MalfunctionMay 3, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE BUT BEFORE USING IT ON THE PATIENT, WHEN THE NEEDLE AND SUTURE WERE TAKEN OUT OF THE PACK, THE NEEDLE CAME OFF THE SUTURE. IT HAPPENED TO EIGHT SUTURE PACKS IN THE BOX. ANOTHER PACK OF SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16864416 ↗
• MalfunctionApr 20, 2021Detachment of Device or Device Component; Packaging Problem; Detachment of Device or Device Component; Packaging Problem

  ACCORDING TO THE REPORTER, PRIOR TO A VETERINARY PROCEDURE, THE NEEDLE WAS SEPARATED FROM THE THREAD UPON OPENING THE PACKET. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11692893 ↗
• MalfunctionFeb 8, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO A VETERINARY PROCEDURE, UPON OPENING THE PACKET, THE NEEDLE WAS DETACHED FROM THE THREAD. THE ISSUE WAS FOUND IN TWO UNITS. ANOTHER DEVICE WAS USED INSTEAD. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11292213 ↗
• MalfunctionMay 8, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LOBECTOMY, THE SUTURE PULLED OFF THE NEEDLE. THEY OPENED A NEW DEVICE TO COMPLETE THE CASE.

  Patient problems: No Information

  MAUDE report 8591615 ↗
• MalfunctionMar 21, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING CAT SPAYING, BOTH THE NEEDLE AND THREAD BROKE. THE SUTURE WAS DETACHING FROM THE NEEDLE AND BREAKING WHEN THE DOCTOR TIED THE KNOTS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8442000 ↗
• MalfunctionMar 8, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A WOUND REPAIR, WHILE CLOSING LACERATION CONTINUED INTRADERMAL PATTERN, NEEDLE DROPPED OFF SUTURE. NEEDED TO KNOT OFF AND THEN PROCEED TO FULL CLOSURE. THE ANIMAL'S WOUND WAS HEALING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7323843 ↗

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: