Steel 88862224-69Recalls & 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
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521102361), received between Jul 9, 2018 and Mar 14, 2023 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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.
Most reported problems
Device problems
- Detachment of Device or Device Component4
- Break1
Patient problems
- Insufficient Information2
- No Clinical Signs, Symptoms or Conditions2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 14, 2023Break; Break
ACCORDING TO THE REPORTER, DURING AN OPEN STERNUM CLOSURE, THE NEEDLE BROKE. THE SURGEON USED ANOTHER STEEL SUTURE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16537613 ↗MalfunctionNov 15, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE NEEDLE BROKE FROM THE STEEL SUTURE.
Patient problems: Insufficient Information
MAUDE report 12817706 ↗MalfunctionNov 15, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE NEEDLE BROKE FROM THE STEEL SUTURE.
Patient problems: Insufficient Information
MAUDE report 12817695 ↗MalfunctionNov 9, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, WHILE CLOSING STERNUM DURING AN OPEN STERNOTOMY, THE NEEDLE BROKE FROM THE STEEL SUTURE. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12779072 ↗MalfunctionJul 9, 2018Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING CLOSURE OF THE STERNUM USING STEEL SUTURES FOLLOWING CARDIAC SURGERY, THE NEEDLE DETACHED FROM THE SUTURE. THE SUTURE WAS STILL ABLE TO BE USED IN THE CLOSURE. ANOTHER FOIL OF STEEL SUTURE WAS OPENED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7669845 ↗
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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