Maxon CV 8886 6122-21Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10884523002065), received between Apr 30, 2018 and Jul 2, 2026 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (12 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 2, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PANCREATIC HEAD TUMOR RESECTION (PANCREATICODUODENECTOMY), WHILE SUTURING THE PANCREATIC DUCT, THE NEEDLE DETACHED. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25693148 ↗
• MalfunctionMar 24, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PANCREATICODUODENECTOMY OR HILAR CHOLANGIOCARCINOMA, AFTER SUTURING IN CHOLEDOCHOJEJUNOSTOMY, SEVERAL NEEDLES DETACHED. TO RESOLVE THE ISSUE, A NEW SUTURE WAS TAKEN OUT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24678628 ↗
• MalfunctionMar 24, 2026Detachment of Device or Device Component; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A PANCREATICODUODENECTOMY OR HILAR CHOLANGIOCARCINOMA, AFTER SUTURING IN CHOLEDOCHOJEJUNOSTOMY, SEVERAL NEEDLES DETACHED. TO RESOLVE THE ISSUE, A NEW SUTURE WAS TAKEN OUT. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 24678405 ↗
• MalfunctionDec 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, IN AN OPEN PROCEDURE, WHILE SUTURING THE INCISION USING THE CONTINUOUS SUTURING TECHNIQUE, THE NEEDLE AND THREAD DETACHED. AN ADDITIONAL SUTURE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23804898 ↗
• MalfunctionDec 3, 2025Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information

  DUPLICATE OF (B)(4).

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

  MAUDE report 23706753 ↗
• MalfunctionFeb 23, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A CARDIOVASCULAR SURGERY, WHILE USING THE DEVICE DURING WOUND OR SURGICAL INCISION CLOSURE AT THE TIME OF CLINICAL EVALUATION, THE NEEDLE 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 16428884 ↗
• MalfunctionFeb 3, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE DETACHED FROM THE THREAD BEFORE BEING USED. A NEW SUTURE WAS UTILIZED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13442864 ↗
• MalfunctionFeb 1, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE POPPED OF FROM THE SUTURE THREAD BEFORE BEING USED.

  Patient problems: Insufficient Information

  MAUDE report 13420042 ↗
• MalfunctionJan 5, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE THREAD WAS POPPING OFF OF NEEDLE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13167787 ↗
• MalfunctionDec 17, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC TOTAL PANCREATECTOMY PROCEDURE, TWO OF THESE SUTURES JUST POPPED OFF FROM THE NEEDLE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13025033 ↗
• InjuryJun 18, 2021Break; Break

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC ROBOTIC UROLOGICAL SURGERY DURING ANASTOMOSIS OF THE URETER THE THREAD BROKE WITH SIX DIFFERENT BREAKS IN THE SUTURE. TO RESOLVE THE ISSUE, TWO PACKS OF DOUBLE ARMED SUTURE WAS OPENED AND USED BY THE SURGEON TO COMPLETE THE PROCEDURE. THE SURGICAL TIME WAS EXTENDED FOR MORE THAN 30 MINUTES.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12024682 ↗
• MalfunctionMay 29, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN OPENING THE PACKAGE, THE NEEDLE AND THE THREAD WERE NOTED 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 10100657 ↗
• MalfunctionFeb 28, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, ON AN OPEN KIDNEY TRANSPLANT, WHILE SUTURING DURING THE URETER ANASTOMOSIS, THE NEEDLE DETACHED FROM ONE END AND THE NEEDLE FROM THE OTHER END OF THE SUTURE BROKE. ANOTHER SUTURE FROM THE SAME LOT WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8377766 ↗
• MalfunctionApr 30, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING A PROCEDURE, THE NURSE TRIED TO PULL OUT THE PRODUCT, HOLDING THE NEEDLE WITH A PAIR OF FORCEPS, THEN THE NEEDLE BECAME DETACHED. THERE WAS NO PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7472310 ↗

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: