Maxon SMM-5526Recalls & reported problems
Covidien LP · Monofilament Absorbable Suture · Class 2 · Implant
Quick summary
This Covidien Maxon absorbable suture has 123 adverse event reports, with no deaths or injuries. Most reports describe the needle coming off the monofilament suture during preparation, and some describe the suture breaking or bending during use. 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
- 123
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 123 adverse event reports that list this exact device (DI 10884523004717), received between Nov 17, 2017 and Apr 17, 2026 — classified as 123 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (102 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 Component102
- Break22
- Insufficient Device Problem Information2
- Adverse Event Without Identified Device or Use Problem1
- Component Missing1
- Material Twisted/Bent1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions82
- No Consequences Or Impact To Patient12
- Insufficient Information11
- No Information8
- No Patient Involvement8
- No Known Impact Or Consequence To Patient5
- Tissue Breakdown1
- Unintended Radiation Exposure1
Recent adverse event reports
The 25 most recent of 123 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 17, 2026Component Missing
ACCORDING TO THE REPORTER, DURING EXCISION OF A BENIGN SUBCUTANEOUS TUMOR, WHEN OPENING THE PACKAGE, THE NEEDLE ATTACHED SUTURE WAS NOT INCLUDED. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24906494 ↗MalfunctionFeb 20, 2026Detachment of Device or Device Component
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF AN ILEUS RELEASE SURGERY, DURING DERMAL SUTURING, THE NEEDLE DETACHED. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24403246 ↗MalfunctionFeb 18, 2026Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A RESECTION OF SOFT TISSUE TUMOR, WHEN PULLING OUT FROM THE RETAINER AND PREPARING FOR SUTURING BEFORE PATIENT USE, THE NEEDLE WAS DETACHED. A NEW SUTURE WAS USED WITHOUT ANY PROBLEMS. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24381772 ↗MalfunctionJan 12, 2026Detachment of Device or Device Component
ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE NEEDLE DETACHED FROM THE SUTURE WHILE BEING PULLED FROM THE RETAINER DURING PREPARATION FOR SUTURING. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24044958 ↗MalfunctionDec 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, PRIOR TO PATIENT USE, A NEEDLE DETACHED FROM THE SUTURE WHILE WITHDRAWING FROM THE RETAINER. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23927225 ↗MalfunctionDec 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT PRIOR TO USE, THE NEEDLE DETACHED. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23924532 ↗MalfunctionDec 23, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent
IT WAS REPORTED THAT DURING AN OPEN NASAL SURGERY AT THE CLOSING STEP, WHILE SUTURING, THE NEEDLE BENT AND THE SUTURE BROKE. ANOTHER SUTURE WAS OPENED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23881904 ↗MalfunctionDec 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT PREOPERATIVELY, OF A VETERINARY CASE, THE NEEDLE DETACHED. IT WAS NOTED THAT THE SUTURES WERE TO BE REPLACED. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23793967 ↗MalfunctionOct 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, THE NEEDLES POPPED OFF THE SUTURES EITHER WHEN REMOVING FROM THE PACKAGE OR DURING STITCHING. ANOTHER SUTURE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23360161 ↗MalfunctionOct 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, THE NEEDLES POPPED OFF THE SUTURES EITHER WHEN REMOVING FROM THE PACKAGE OR DURING STITCHING. ANOTHER SUTURE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23360093 ↗MalfunctionOct 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, PRIOR TO PROCEDURE, WHEN BEING REMOVED FROM PACKAGING, THE NEEDLES POPPED OFF THE SUTURES. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23358893 ↗MalfunctionOct 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, PRIOR TO PROCEDURE, WHEN BEING REMOVED FROM PACKAGING, THE NEEDLES POPPED OFF THE SUTURES. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23358839 ↗MalfunctionOct 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE FOR SKIN LESION, THE NEEDLES POP OFF EITHER WHEN REMOVING FROM THE PACKAGE OR DURING STITCHING. ANOTHER SUTURE WAS USED AND MAKE MORE KNOTS IN THE INCISION TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23310524 ↗MalfunctionOct 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE FOR SKIN LESION, THE NEEDLES POPPED OFF EITHER WHEN REMOVING FROM THE PACKAGE OR DURING STITCHING. ANOTHER SUTURE WAS USED AND MAKE MORE KNOTS IN THE INCISION TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23307364 ↗MalfunctionSep 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER DURING A SUBCUTANEOUS SUTURE PROCEDURE, THE SUTURE BROKE AT THE SUTURE ATTACHMENT POINT. THE ISSUE WAS RESOLVED BY OPENING A NEW PACKAGE OF SUTURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23058552 ↗MalfunctionSep 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER DURING A PROCEDURE, THE SUTURE BROKE AT THE SUTURE ATTACHMENT POINT. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23057892 ↗MalfunctionSep 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER DURING A PROCEDURE, THE SUTURE BROKE AT THE SUTURE ATTACHMENT POINT. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23057758 ↗MalfunctionSep 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER DURING A PROCEDURE, THE SUTURE BROKE AT THE SUTURE ATTACHMENT POINT. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23057723 ↗MalfunctionSep 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER DURING A PROCEDURE, THE SUTURE BROKE AT THE SUTURE ATTACHMENT POINT. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23057562 ↗MalfunctionSep 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER DURING A PROCEDURE, THE SUTURE BROKE AT THE SUTURE ATTACHMENT POINT. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23057035 ↗MalfunctionAug 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, PREOPERATIVELY, AFTER THE NEEDLE WAS GRASPED WITH THE NEEDLE HOLDER, THE SUTURE WAS DISENGAGED/DETACHED FROM THE NEEDLE. A NEW SUTURE USED WITHOUT ANY PROBLEMS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22921904 ↗MalfunctionAug 26, 2025Break; Break
IT WAS REPORTED THAT DURING A PROCEDURE, WHILE SUTURING, THE SUTURE BROKE IN THE MIDDLE, WHICH CAUSED DAMAGE THAT MAY NEED REVISIONAL SURGERIES AND REQUIRED EXTRA TIME TO AMEND THE ISSUE. 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 22896310 ↗MalfunctionOct 25, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE POPS OFF WHILE THE DOCTOR IS SUTURING.
Patient problems: Insufficient Information
MAUDE report 20538416 ↗MalfunctionSep 22, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE POPS OFF WHILE THE DOCTOR IS SUTURING.
Patient problems: Insufficient Information
MAUDE report 20276116 ↗MalfunctionJul 23, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, THE NEEDLES POPPED OFF.
Patient problems: Insufficient Information
MAUDE report 19805580 ↗
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:
Other SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID devices
- Coated VICRYL VCP433HEthicon, LLC · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 death1,093 reports
- Polysorb CL-915Covidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID503 reports
- Coated VICRYL VCP493HEthicon, LLC · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID435 reports
- V-Loc 180 VLOCL0316Covidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall376 reports
- Coated VICRYL VCP345HEthicon, LLC · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 death405 reports
- V-Loc 180 VLOCL0604Covidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall328 reports
- V-Loc 180 VLOCA008LCovidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall294 reports
- V-Loc 180 VLOCL0326Covidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID330 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.