Maxon XX-2109Recalls & reported problems
Covidien LP · Monofilament Absorbable Suture · Class 2 · Implant
All models of Maxon (114)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521143098), received between Sep 10, 2018 and Nov 2, 2022 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (2 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 16, 2026.
Most reported problems
Device problems
- Break2
Patient problems
- No Known Impact Or Consequence To Patient1
- Unintended Radiation Exposure1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 2, 2022Break; Break
ACCORDING TO THE REPORTER, DURING A LAPAROTOMY FOR HEMOSTASIS OF ESOPHAGEAL OP BLOOD VESSEL, WHEN USED FOR PENETRATING LIGATION DURING VASCULAR PROCESSING OF ESOPHAGEAL OP, THE NEEDLE BROKE. AN X-RAY WAS DONE IN ORDER TO SPECIFY THE NEEDLE POSITIONING. A NEW SUTURE FROM THE SAME BATCH WAS USED TO COMPLETE THE PROCEDURE.
Patient problems: Unintended Radiation Exposure
MAUDE report 15715027 ↗MalfunctionSep 10, 2018Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE WHILE IN USE FOR THE PATIENT, THE SUTURE BROKE EASILY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7861912 ↗
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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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