Maxon XX-2106Recalls & reported problems
Covidien LP · Monofilament Absorbable Suture · Class 2 · Implant
Quick summary
This Covidien Maxon XX-2106 is an absorbable synthetic suture (polyglycolic acid monofilament) used to close skin and surgical wounds. Its 59 reports mostly describe the thread breaking during suturing, or the needle coming apart from the thread — sometimes already separated when the package was opened — with the suture then pulled out and another one used. The reports describe no deaths and no injuries, and 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
- 59
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 10884521154124), received between Feb 8, 2018 and Aug 28, 2024 — classified as 59 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (38 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 Component38
- Break24
- Insufficient Device Problem Information1
- Packaging Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions57
- Insufficient Information8
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 59 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 28, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, WHEN PREPARING THE SUTURE DURING THE DERMAL SUTURE OF THE FORMATION, IT WAS FOUND THAT THE NEEDLE WAS DETACHED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20091909 ↗MalfunctionMay 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A DERMAL IN PLASTIC SURGERY, WHEN SUTURING, THE THREAD CAME OFF OR DETACHED FROM THE SUTURE PART. IT DETACHED EVEN THOUGH IT WAS NOT DETACHED. IT OCCURRED ON TWO SUTURES. IT WAS NOTED THAT NO COMPONENTS FELL INTO THE PATIENT'S CAVITY. THE SAME MODEL OF SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19270026 ↗MalfunctionMay 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A DERMAL IN PLASTIC SURGERY, WHEN SUTURING, THE THREAD CAME OFF OR DETACHED FROM THE SUTURE PART. IT DETACHED EVEN THOUGH IT WAS NOT DETACHED. IT OCCURRED ON TWO SUTURES. IT WAS NOTED THAT NO COMPONENTS FELL INTO THE PATIENT'S CAVITY. THE SAME MODEL OF SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19269901 ↗MalfunctionApr 18, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, INTRAOPERATIVELY, LAPAROSCOPIC SURGERY, PRIOR TO PATIENT USE, THE SWAGE OF THE NEEDLE AND THREAD ARE DISCONNECTED WHEN OPENING THE PACKET. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19129976 ↗MalfunctionApr 4, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A PLASTIC SURGERY, WHEN DERMAL SUTURING , THE THREAD BROKE. IT OCCURRED ON THREE SUTURES. IT WAS NOTED THAT ANOTHER NEW SUTURE WAS USED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19044864 ↗MalfunctionApr 4, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A PLASTIC SURGERY, WHEN DERMAL SUTURING , THE THREAD BROKE. IT OCCURRED ON THREE SUTURES. IT WAS NOTED THAT ANOTHER NEW SUTURE WAS USED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19044574 ↗MalfunctionApr 4, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A PLASTIC SURGERY, WHEN DERMAL SUTURING , THE THREAD BROKE. IT OCCURRED ON THREE SUTURES. IT WAS NOTED THAT ANOTHER NEW SUTURE WAS USED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19044515 ↗MalfunctionApr 4, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING PLASTIC SURGERY, THE TWO NEEDLES AND THREADS WERE DETACHED FROM THE SWAGE DURING USE IN DERMAL SUTURE. THE NEEDLE AND SUTURE WERE REMOVED FROM THE SUTURED AREA DURING USE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19043157 ↗MalfunctionApr 4, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING PLASTIC SURGERY, THE TWO NEEDLES AND THREADS WERE DETACHED FROM THE SWAGE DURING USE IN DERMAL SUTURE. THE NEEDLE AND SUTURE WERE REMOVED FROM THE SUTURED AREA DURING USE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19043030 ↗MalfunctionApr 4, 2024Break; Break
ACCORDING TO THE REPORTER, DURING THE DERMAL SUTURING BOTH SUTURE WAS CUT NEAR THE SUTURE AREA. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19042606 ↗MalfunctionApr 4, 2024Break; Break
ACCORDING TO THE REPORTER, DURING THE DERMAL SUTURING BOTH SUTURE WAS CUT NEAR THE SUTURE AREA. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19042570 ↗MalfunctionFeb 28, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A LAPAROTOMY PROCEDURE, THREE SUTURE THREADS BROKE EASILY DURING DERMAL SUTURING. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18802935 ↗MalfunctionFeb 28, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A LAPAROTOMY PROCEDURE, THREE SUTURE THREADS BROKE EASILY DURING DERMAL SUTURING. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18802908 ↗MalfunctionFeb 28, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A LAPAROTOMY PROCEDURE, THREE SUTURE THREADS BROKE EASILY DURING DERMAL SUTURING. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18801154 ↗MalfunctionJan 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN THE PACKET WAS OPENED, IT WAS DISCOVERED THAT THE NEEDLE WAS DETACHED FROM THE THREAD, SO THE USE OF THE DEVICE WAS DISCONTINUED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18591777 ↗MalfunctionJan 2, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE THE SURGEON FOUND THAT THE NEEDLE AND SUTURE WERE NOT CONNECTED UPON OPENING THE PACKET. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18426619 ↗MalfunctionDec 21, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN THE PACKET WAS OPENED, IT WAS DISCOVERED THAT THE NEEDLE WAS DETACHED FROM THE THREAD, SO THE USE OF THE DEVICE WAS DISCONTINUED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18374273 ↗MalfunctionOct 11, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PLASTIC SURGERY, WHEN PULLING THE SUTURE OUT OF THE PACKAGE, THE THREAD CAME OUT OF THE NEEDLE WHEN THE SURGEON HELD IT WITH A NEEDLE HOLDER. ANOTHER SUTURE WAS OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17909977 ↗MalfunctionOct 10, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, INTRAOPERATIVELY, BEFORE USING DEVICE FOR DERMAL SUTURING, THE NEEDLE WAS NOT ATTACHED TO THE THREAD. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17907322 ↗MalfunctionOct 10, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING PLASTIC SURGERY, WHILE THE SURGEON WAS SUTURING THE DERMIS, THE NEEDLE DETACHED FROM THE SUTURE THREAD. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 17905417 ↗MalfunctionOct 10, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING PLASTIC SURGERY, WHEN THE SCRUB NURSE WAS PULLING OUT THE SUTURE, THE THREAD BROKE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 17905384 ↗MalfunctionOct 10, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING DERMAL SUTURING FOR A PLASTIC SURGERY, THE THREAD OF THE TWO SUTURES BROKE WHEN GRASPING THE SUTURE USING A NEEDLE HOLDER. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 17905313 ↗MalfunctionOct 10, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING DERMAL SUTURING FOR A PLASTIC SURGERY, THE THREAD OF THE TWO SUTURES BROKE WHEN GRASPING THE SUTURE USING A NEEDLE HOLDER. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 17905187 ↗MalfunctionOct 4, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A DERMAL PLASTIC SURGERY, THE NEEDLE AND THREAD DETACHED WHEN IT WAS BEING PULLED OUT. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17866250 ↗MalfunctionOct 4, 2023Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information
ACCORDING TO THE REPORTER, DURING A DERMAL PLASTIC SURGERY, THE NEEDLE AND THREAD DETACHED WHEN IT WAS BEING PULLED OUT. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 17866247 ↗
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.