Steel 88862228-89Recalls & 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
- 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 10884521102408), received between Jul 12, 2024 and May 1, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 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 Component5
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Insufficient Information1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 1, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE SUTURE, THE NEEDLES BROKE OFF THE STEEL WIRE MULTIPLE TIMES WHILE SUTURING/PREPARING THE SUTURE AFTER PATIENT INCISION. THIS RESULTED IN THE USE OF MULTIPLE WIRES, LEADING TO DELAYS IN CLOSING THE STERNUM. AN ADDITIONAL NEW SUTURE WAS THEN USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21945948 ↗MalfunctionAug 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A AORTIC VALVE REPLACEMENT FULL STERNOTOMY, WHILE USING THE FIRST STEEL SUTURE, THE NEEDLE CAME OFF ONCE GONE THROUGH THE STERNUM AND WAS TRYING TO PULL THROUGH. THE SAME ISSUE OCCURRED WITH THE SECOND SUTURE. A NEW SUTURE WAS USED TO CLOSE THE STERNUM. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19912953 ↗MalfunctionAug 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A AORTIC VALVE REPLACEMENT FULL STERNOTOMY, WHILE USING THE FIRST STEEL SUTURE, THE NEEDLE CAME OFF ONCE GONE THROUGH THE STERNUM AND WAS TRYING TO PULL THROUGH. THE SAME ISSUE OCCURRED WITH THE SECOND SUTURE. A NEW SUTURE WAS USED TO CLOSE THE STERNUM. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19912640 ↗MalfunctionJul 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, THE NEEDLE CAME OFF THE THE WIRE (THREAD).
Patient problems: Insufficient Information
MAUDE report 19794291 ↗MalfunctionJul 12, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER DURING THE STERNUM CLOSURE, THE NEEDLE CAME OFF THE THE WIRE (THREAD). THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19734017 ↗
Other SUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE devices
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- 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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