Maxon 8886 6235-41Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10884523002454), received between Dec 6, 2017 and Jul 29, 2026 — classified as 19 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50065373 ↗
• MalfunctionJul 29, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50065367 ↗
• MalfunctionFeb 17, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE PARTIAL GASTRECTOMY, SIX SUTURES EXPERIENCED NEEDLE DETACHMENT. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24373675 ↗
• MalfunctionFeb 16, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PARTIAL GASTRECTOMY, SIX SUTURES EXPERIENCED NEEDLE DETACHMENT. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24350340 ↗
• MalfunctionFeb 16, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PARTIAL GASTRECTOMY, SIX SUTURES EXPERIENCED NEEDLE DETACHMENT. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24350123 ↗
• MalfunctionFeb 16, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PARTIAL GASTRECTOMY, SIX SUTURES EXPERIENCED NEEDLE DETACHMENT. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24343845 ↗
• MalfunctionFeb 16, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PARTIAL GASTRECTOMY, SIX SUTURES EXPERIENCED NEEDLE DETACHMENT. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24343749 ↗
• MalfunctionFeb 16, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PARTIAL GASTRECTOMY, SIX SUTURES EXPERIENCED NEEDLE DETACHMENT. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24343714 ↗
• MalfunctionFeb 9, 2026Break

  ACCORDING TO THE REPORTER, DURING LIGATION IN PERITONEAL SUTURING, THE SUTURE BROKE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24299313 ↗
• MalfunctionOct 23, 2025Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE THREAD CAME LOOSE FROM THE NEEDLE, AND SUDDENLY THE NEEDLE ENDED UP IN THE PATIENT'S BELLY. IT WAS NOTED THAT IT WAS A LITTLE DIFFICULT TO REMOVE, BUT IT SUCCEEDED, AND THE SURGICAL TIME WAS EXTENDED FOR MORE THAN 30 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23373220 ↗
• MalfunctionJun 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A ESOPHAGEAL RESECTION PROCEDURE, THE NEEDLE CAME LOOSE FROM THE SUTURE. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22341482 ↗
• MalfunctionJun 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A ESOPHAGEAL RESECTION PROCEDURE, THE NEEDLE CAME LOOSE FROM THE THREAD. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 22298764 ↗
• MalfunctionAug 12, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A GASTROENTEROSTOMY, WHILE SUTURING, THE NEEDLES OF TWO SUTURES DETACHED. BOTH NEEDLES FELL INTO THE PATIENT¿S CAVITY AND WERE RETRIEVE WITH LAPAROSCOPIC INSTRUMENTS. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19967157 ↗
• MalfunctionOct 23, 2023Break; Break

  ACCORDING TO THE REPORTER, THE SUTURE BROKE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17993174 ↗
• MalfunctionMar 16, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC DUODENAL SWITCH, HALF WAY IN THE PROCEDURE, THE SURGEON WAS USING THE SUTURE TO COMPLETE THE ANASTOMOSIS OF THE BOWEL AND WAS TYING WHEN THE THREAD BROKE. ANOTHER SUTURE FROM THE SAME BOX WAS OPENED AND WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11499843 ↗
• MalfunctionOct 9, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE NEEDLES WERE DETACHING VERY EASILY FROM THE SUTURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7946522 ↗
• MalfunctionOct 9, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE NEEDLES WERE DETACHING VERY EASILY FROM THE SUTURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7946490 ↗
• MalfunctionJan 31, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING WOUND CLOSURE, THE DEVICES BROKE, WHEREIN THREE (3) OF SAME SUTURE WERE OPENED TO DISCOVER NEEDLES WERE SEPARATED FROM SUTURE MATERIAL IN PACKAGING BEFORE BEING REMOVED. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7232236 ↗
• MalfunctionDec 6, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC COLECTOMY PROCEDURE, THE DEVICE NEEDLE CAME TOTALLY LOOSE FROM THE SUTURE STRAND DURING THE CLOSURE OF THE COLON. NO BREAKAGE WAS NOTED BUT THE SUTURE CAME LOOSE FROM THE NEEDLE SWAGE. NO PATIENT INJURY HAS BEEN NOTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7086520 ↗

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: