Maxon 8886 6287-71Recalls & 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 10884523002805), received between Oct 11, 2018 and Jul 25, 2019 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Material Twisted/Bent” (1 report).
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
- Material Twisted/Bent1
- Unraveled Material1
Patient problems
- No Code Available1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 25, 2019Unraveled Material; Unraveled Material
ACCORDING TO THE REPORTER, FOLLOWING A CAESAREAN SECTION PROCEDURE, THE SUTURE THREAD BROKE IN THE MIDDLE. THE PATIENT WENT BACK TO THEATRE TO CLOSE THE SHEATH AGAIN. THIS RESULTED TO EXTENDED SURGICAL TIME OF MORE THAN 30 MINUTES AND EXTENDED PATIENT HOSPITALIZATION OF FOUR DAYS.
Patient problems: No Code Available
MAUDE report 8829442 ↗MalfunctionOct 11, 2018Material Twisted/Bent; Material Twisted/Bent
ACCORDING TO THE REPORTER, DURING AN OPEN HIP REPLACEMENT PROCEDURE, THE DEVICE NEEDLE BENT. THEY THEN USED ANOTHER DEVICE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7955876 ↗
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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