Steel 88862224-89Recalls & 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
- 8
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10884521102378), received between Dec 15, 2020 and Nov 13, 2024 — classified as 2 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (6 reports).
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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component6
- Break2
- Dull, Blunt1
- Material Twisted/Bent1
Patient problems
- Insufficient Information4
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
InjuryNov 13, 2024Detachment of Device or Device Component; Material Twisted/Bent; Detachment of Device or Device Component; Material Twisted/Bent
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE BENT WHILE IN USE AND THE NEEDLE DETACHED BUT IT DID NOT FALL INTO PATIENT¿S CAVITY. A NEW SUTURE WAS USED TO COMPLETE THE CASE. HOSPITALIZATION WAS EXTENDED.
Patient problems: Insufficient Information
MAUDE report 20673504 ↗InjuryNov 8, 2024Break; Dull, Blunt; Break; Dull, Blunt
ACCORDING TO THE REPORTER, INTRAOPERATIVELY, DURING STERNAL CLOSURE, THE SUTURE NEEDLE LOST ITS FIRMNESS AND SHARPNESS, SUBSEQUENTLY WHEN INTERLACING THE SUTURE. THE SUTURE FAILED TO MAINTAIN ITS TENSILE STRENGTH, WAS RELEASED AT TWO OF THE POINTS, AND BROKE IN THE MIDDLE. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. IT WAS ALSO REPORTED THAT THE PATIENT EXTENDED HOSPITALIZATION.
Patient problems: Insufficient Information
MAUDE report 20637330 ↗MalfunctionOct 14, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE NEEDLE DETACHED. THE SUTURE BROKE AT THE CONNECTION OF NEEDLE AND THREAD.
Patient problems: Insufficient Information
MAUDE report 20438989 ↗MalfunctionSep 4, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE WIRE CAME OUT OF NEEDLE.
Patient problems: Insufficient Information
MAUDE report 20138701 ↗MalfunctionDec 15, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A CORONARY ARTERY BYPASS GRAFTING, ON CLOSURE OF THE STERNUM, THE NEEDLE PULLED OFF THE STRAND AND REMAINED IN THE NEEDLE HOLDER. A STEEL SUTURE FROM A DIFFERENT MANUFACTURER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11013756 ↗MalfunctionDec 15, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING THE CLOSURE OF THE STERNUM ON AN OPEN CORONARY ARTERY BYPASS GRAFT, THE NEEDLE CAME OFF THE STRAND AND REMAINED IN THE NEEDLE HOLDER. AN OPPOSITION STEEL SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11013755 ↗MalfunctionDec 15, 2020Break; Break
ACCORDING TO THE REPORTER, DURING A CORONARY ARTERY BYPASS GRAFTING, ON CLOSURE OF THE STERNUM, THE NEEDLE PULLED OFF THE STRAND, AND REMAINED IN THE NEEDLE HOLDER. A STEEL SUTURE FROM A DIFFERENT MANUFACTURER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11012473 ↗MalfunctionDec 15, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A CORONARY ARTERY BYPASS GRAFTING, WHEN PASSING IN THE CLOSURE OF THE STERNUM BONE, THE NEEDLE DETACHED FROM THE STRAND. A STEEL SUTURE FROM A DIFFERENT MANUFACTURER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11012114 ↗
Other SUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE devices
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- 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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