Maxon SMM-5831Recalls & reported problems
Covidien LP · Monofilament Absorbable Suture · Class 2 · Implant
Quick summary
This Maxon absorbable suture is a dissolvable stitch used to close wounds. Reports mostly describe the needle coming loose from the thread before or during stitching, with some needles breaking. There are 42 reports that name its identifier, with no deaths and 4 injuries mentioned. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 41
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 10884523004885), received between Sep 1, 2017 and Jun 25, 2026 — classified as 4 injuries, 37 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (29 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component29
- Break10
- Adverse Event Without Identified Device or Use Problem2
- Unraveled Material2
- Dull, Blunt1
Patient problems
- No Clinical Signs, Symptoms or Conditions16
- Insufficient Information12
- No Known Impact Or Consequence To Patient7
- No Consequences Or Impact To Patient3
- Unintended Radiation Exposure2
- Wound Dehiscence2
- Device Embedded In Tissue or Plaque1
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 25, 2026Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING DERMAL SUTURING FOR WOUND CLOSURE IN A PANCREATICODUODENECTOMY PROCEDURE, THE NEEDLE DETACHED FROM THE SUTURE. TWO UNITS FROM THE SAME LOT EXPERIENCED THE SAME ISSUE DURING THE SAME CASE. A NEW SUTURE WAS THEN USED WITHOUT FURTHER ISSUES TO CONTINUE THE PROCEDURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25630613 ↗MalfunctionAug 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, IT WAS DISCOVERED THAT THE NEEDLE WAS DETACHED FROM THE SUTURE UPON OPENING THE PACKAGE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22891488 ↗InjuryApr 3, 2025Break; Break
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, DURING SUBCUTANEOUS SUTURING TO CLOSE A WOUND AFTER RELIEVING ILEUS, THE TIP OF THE NEEDLE BROKE. AN X-RAY WAS DONE TO IDENTIFY THE NEEDLE POSITION, BUT THE NEEDLE TIP WAS NOT LOCATED.
Patient problems: Unintended Radiation Exposure
MAUDE report 21769625 ↗MalfunctionJan 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER PRIOR TO USE, THE NEEDLE WAS DETACHED WHEN IT WAS BEING PULLED OUT FROM THE RETAINER AND PREPARED FOR SUTURING. ANOTHER NEW SUTURE WAS USED WITHOUT PROBLEMS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21273649 ↗MalfunctionDec 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NURSE DISCOVERED THAT THE THREAD AND NEEDLE WERE NOT CONNECTED WHEN OPENING THE PACKAGE. THE PRODUCT WAS DISCONTINUED FROM USE, AND A NEW PRODUCT WAS OPENED WITHOUT ANY PROBLEM.
Patient problems: Insufficient Information
MAUDE report 21025840 ↗MalfunctionOct 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, WHEN AN ATTEMPT WAS MADE TO REMOVE THE SUTURE FROM THE PACKET, THE NEEDLE CAME OFF THE SUTURE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20538037 ↗MalfunctionAug 28, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, PRIOR TO USE OF THE DEVICE IN A PROCEDURE, UPON OPENING OF THE PACKAGE IT WAS FOUND THAT THE NEEDLE AND SUTURE WERE DETACHED. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20091286 ↗MalfunctionJul 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE DETACHED FROM THE THREAD WHEN SUTURING.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 19683062 ↗MalfunctionJun 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING SKIN CLOSURE PROCEDURE AND WOUND CLOSURE, THE NEEDLE DETACHES FROM THE THREAD WHEN SUTURING FOR ALL 8 DEVICE. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information
MAUDE report 19628060 ↗MalfunctionJun 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING SKIN CLOSURE PROCEDURE AND WOUND CLOSURE, THE NEEDLE DETACHES FROM THE THREAD WHEN SUTURING FOR ALL 8 DEVICE. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information
MAUDE report 19627999 ↗MalfunctionJun 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING SKIN CLOSURE PROCEDURE AND WOUND CLOSURE, THE NEEDLE DETACHES FROM THE THREAD WHEN SUTURING FOR ALL 8 DEVICE. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information
MAUDE report 19625523 ↗MalfunctionJun 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING SKIN CLOSURE PROCEDURE AND WOUND CLOSURE, THE NEEDLE DETACHES FROM THE THREAD WHEN SUTURING FOR ALL 8 DEVICE. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information
MAUDE report 19625461 ↗MalfunctionJun 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING SKIN CLOSURE PROCEDURE AND WOUND CLOSURE, THE NEEDLE DETACHES FROM THE THREAD WHEN SUTURING FOR ALL 8 DEVICE. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information
MAUDE report 19625404 ↗MalfunctionJun 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING SKIN CLOSURE PROCEDURE AND WOUND CLOSURE, THE NEEDLE DETACHES FROM THE THREAD WHEN SUTURING FOR ALL 8 DEVICE. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information
MAUDE report 19625377 ↗MalfunctionJun 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING SKIN CLOSURE PROCEDURE AND WOUND CLOSURE, THE NEEDLE DETACHES FROM THE THREAD WHEN SUTURING FOR ALL 8 DEVICE. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information
MAUDE report 19625349 ↗MalfunctionJun 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING SKIN CLOSURE PROCEDURE AND WOUND CLOSURE, THE NEEDLE DETACHES FROM THE THREAD WHEN SUTURING FOR ALL 8 DEVICE. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information
MAUDE report 19625298 ↗MalfunctionJun 30, 2023Break; Break
ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE SUTURE NEEDLE WAS BROKEN. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17242619 ↗MalfunctionApr 25, 2022Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE WAS BROKEN WHEN IT WAS HELD WITH A NEEDLE HOLDER. A NEW PRODUCT WAS USED TO COMPLETE THE CASE AND RESOLVE THE ISSUE.
Patient problems: Insufficient Information
MAUDE report 14197719 ↗MalfunctionFeb 8, 2022Break; Break
ACCORDING TO THE REPORTER, DURING SUTURING KNOT OF WOUND CLOSURE IN A STENT GRAFT INTERPOLATION, VASCULAR EMBOLIZATION, THERE WAS SUTURE BREAKAGE. THE SURGEON OPENED ANOTHER PACK TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13481563 ↗MalfunctionJan 27, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A THORACOSCOPY LOBECTOMY, ON WOUND CLOSURE, THE THREAD DISENGAGED. ANOTHER NEW SUTURE USED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13368733 ↗MalfunctionDec 30, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A DERMAL SUTURE, THE 2 NEEDLES DETACHED FROM THREAD WHEN TIED. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13121836 ↗InjuryDec 10, 2021Dull, Blunt; Adverse Event Without Identified Device or Use Problem; Dull, Blunt; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, DURING THORACOSCOPIC BULLECTOMY, AT CLOSURE OF TROCAR WOUND, THE NEEDLE BECAME DULL WHILE STITCHING SEVERAL TIMES, SO USAGE WAS DISCONTINUED. A SUTURE FROM ANOTHER LOT WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THE TIP WAS SUSPECTED TO HAVE REMAINED INSIDE THE BODY SO X-RAY IMAGING WAS PERFORMED, BUT IT COULD NOT BE FOUND.
Patient problems: Device Embedded In Tissue or Plaque; Unintended Radiation Exposure
MAUDE report 12979947 ↗MalfunctionDec 9, 2021Break; Break
ACCORDING TO THE REPORTER, DURING DERMAL SUTURE FOR STENT GRAFT INSERTION, THE THREAD BROKE AT THE INSTRUMENT KNOT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12968802 ↗MalfunctionNov 23, 2021Break; Break
ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC CHOLECYSTECTOMY, THE THREAD BROKE WITH THE INSTRUMENT KNOT ON DERMIS SUTURE. THE SURGEON CONTINUED USING THE DEVICE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12860467 ↗MalfunctionOct 21, 2021Break; Break
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, ON WOUND CLOSURE OF UMBILICAL REGION WITH DERMAL SUTURE, THE TWO THREADS BROKE. ANOTHER PACKAGE OF THE SAME PRODUCT WAS OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12677050 ↗
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 · TerminatedSutures. 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:
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.