Maxon CV 8886 6131-11Recalls & reported problems
Covidien LP · Monofilament Absorbable Suture · Class 2 · Implant
All models of Maxon CV (13)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884523002119), received between Jun 22, 2023 and Jun 22, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Unraveled Material” (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 18, 2026.
Most reported problems
Device problems
- Unraveled Material1
Patient problems
- Failure to Anastomose1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 22, 2023Unraveled Material; Unraveled Material
ACCORDING TO THE REPORTER, POST-OPERATIVELY OF AN OPEN EXPLORATORY LAPAROTOMY AND WHIPPLE WITH SPLENECTOMY, THE PATIENT HAD BILIARY LEAK IN DUCT. THE SUTURES USED DURING THE CASE TO SUTURE THE BILIARY DUCT WERE TIED DOWN AS NORMAL AND DID NOT BREAK. HOWEVER, THE SUTURES DID NOT HOLD. A TOTAL OF 9 SUTURES WERE USED. THE PATIENT NEEDED REOPERATION TO REPAIR THE BILIARY LEAK.
Patient problems: Failure to Anastomose
MAUDE report 17181994 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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