Steel 88862222-89Recalls & reported problems
Covidien LP · Monofilament Stainless Steel · Class 2 · Implant
All models of Steel (15)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521102347), received between Feb 28, 2018 and Feb 28, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
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
- Break1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 28, 2018Break; Break
ACCORDING TO THE REPORTER, DURING MEDIAN STERNOTOMY, THE DEVICE¿S SUTURE BROKE WHILE BEING USED IN CLOSURE OF THE STERNUM. THE NEEDLE WIRE WAS NOT RIGID ENOUGH TO GO THROUGH THE TISSUE. THUS, MADE THE WIRE BROKE FROM THE NEEDLE. NEW DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO INJURY CAUSED TO THE PATIENT AND NO MEDICAL INTERVENTION WAS REQUIRED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7304369 ↗
Other SUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE devices
- ETHICON M660GEthicon, LLC · SUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE102 reports
- ETHICON M650GEthicon, LLC · SUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE68 reports
- ETHIBOND EXCEL X425HEthicon, LLC · SUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE1 recall12 reports
- Steel 88862224-49Covidien LP · SUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE1 recall3 reports
- ETHICON M655GEthicon, LLC · SUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE46 reports
- ETHIBOND EXCEL MB66GEthicon, LLC · SUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE42 reports
- Steel 88862424-89Covidien LP · SUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE39 reports
- ETHICON M649GEthicon, LLC · SUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE36 reports
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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