Steel 88862424-89Recalls & 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
Quick summary
This Covidien steel monofilament suture is a non-absorbable stainless steel stitch used to close the breastbone and other tissue. The 39 reports mostly describe the needle coming loose from, or breaking away from, the steel wire thread while a surgeon was stitching — for example during chest closure after heart surgery. No deaths or injuries are reported, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 39
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 10884521102699), received between Nov 10, 2017 and Nov 9, 2024 — classified as 39 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (30 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 Component30
- Break20
Patient problems
- No Clinical Signs, Symptoms or Conditions20
- No Consequences Or Impact To Patient13
- No Known Impact Or Consequence To Patient6
- Insufficient Information1
- Radiation Exposure, Unintended1
Recent adverse event reports
The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, THE NEEDLE CAME OFF FROM THE STERNAL WIRE AS THE SURGEON WAS USING IT.
Patient problems: Insufficient Information
MAUDE report 20647016 ↗MalfunctionNov 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE CAME OFF FROM THE STERNAL WIRE AS THE SURGEON WAS USING IT ON STERNUM AS A 2ND BITE. SAME HAPPENED WITH THE 2ND NEEDLE FROM SAME PACKET. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20646151 ↗MalfunctionNov 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE CAME OFF FROM THE STERNAL WIRE AS THE SURGEON WAS USING IT ON STERNUM AS A 2ND BITE. THE SAME HAPPENED WITH THE 2ND NEEDLE FROM SAME PACKET. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20645943 ↗MalfunctionAug 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A CLOSURE OF THE STERNUM AFTER CARDIAC SURGERY PROCEDURE, THE TWO NEEDLE DETACHED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20035852 ↗MalfunctionAug 20, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A CLOSURE OF THE STERNUM AFTER CARDIAC SURGERY PROCEDURE, THE TWO NEEDLE DETACHED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20003754 ↗MalfunctionFeb 15, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF AN OPEN BYPASS PROCEDURE, WHILE CLOSING THE STERNUM, THE NEEDLE AND THREAD SEPARATED. ANOTHER DEVICE FROM THE SAME LOT NUMBER WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16380514 ↗MalfunctionJun 16, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING AN OPEN HEART PROCEDURE, AT THE TIME OF CLOSING THE STERNUM, WHILE DOING THE SINGLE INTERRUPTED SUTURING TECHNIQUE, AFTER THE FIRST BITE, WHEN THE SURGEON PUT THE NEEDLE THROUGH THE STERNUM, THE NEEDLE CAME LOOSE FROM THE STEEL THREAD. THIS HAPPENED TWICE. A NEW STEEL SUTURE FROM A DIFFERENT LOT WAS USED TO COMPLETE THE CASE. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14711668 ↗MalfunctionMay 5, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING AN OPEN CORONARY ARTERY BYPASS GRAFT PROCEDURE, WHEN CLOSING STERNOTOMY, WHILE USING A CONTINUOUS SUTURE TECHNIQUE, THE NEEDLE AND THREAD BROKE AND WERE SEPARATED FROM EACH OTHER. THE SURGEON USED ANOTHER SUTURE WITH DIFFERENT LOT NUMBER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14291376 ↗MalfunctionMar 24, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING STERNUM CLOSURE, THE TWO NEEDLES BROKE OFF FROM THE STEEL THREAD AS A WHOLE WHICH WERE FRESHLY UNPACKED. ANOTHER STEEL SUTURE WITH ANOTHER LOT NUMBER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13889942 ↗MalfunctionFeb 25, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING STERNUM CLOSURE, THE NEEDLE BROKE OFF FROM THE STEEL THREAD AS A WHOLE. ANOTHER STEEL SUTURE WITH ANOTHER LOT NUMBER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13601910 ↗MalfunctionFeb 25, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING STERNUM CLOSURE, THE NEEDLE BROKE OFF FROM THE STEEL THREAD AS A WHOLE. ANOTHER STEEL SUTURE WITH ANOTHER LOT NUMBER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13601838 ↗MalfunctionFeb 25, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, ON A SINGLE INTERRUPTED SUTURE TECHNIQUE WHILE CLOSING THE STERNUM, THE NEEDLE BROKE OFF FROM THE STEEL THREAD AS A WHOLE. ANOTHER STEEL SUTURE WITH ANOTHER LOT NUMBER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13599479 ↗MalfunctionJan 10, 2022Break; Break
ACCORDING TO THE REPORTER, DURING OPEN CORONARY ARTERY BYPASS GRAFTING (CABG), WHEN CLOSING STERNOTOMY, THE NEEDLE BROKE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13206505 ↗MalfunctionDec 23, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, ON AN OPEN STERNAL CLOSURE, AT THE LAST PERIOD OF THE PROCEDURE, AFTER THE STEEL WIRE HAS PASSED THROUGH THE TISSUE, THE NEEDLE IS SEPARATED FROM THE THREAD JOINT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13070451 ↗MalfunctionNov 9, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING AN OPEN STERNOTOMY, THE STEEL AND NEEDLE CONNECTION WAS BROKEN. THE SAME ISSUE HAPPENED TWICE. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12779031 ↗MalfunctionOct 19, 2021Break; Break
ACCORDING TO THE REPORTER, DURING AN OPEN CARDIAC SURGERY, WHILE CLOSING THE STERNUM, THE NEEDLE BROKE. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12662198 ↗MalfunctionOct 14, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING STERNUM SUTURING WITH STEEL IN AN OPEN CORONARY ARTERY BYPASS GRAFT (CABG), THE SUTURE BREAK FROM THE NEEDLE ON FIVE DEVICES. TO RESOLVE THE ISSUE, A NEW DEVICE FROM A NEW BOX WAS USED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12636061 ↗MalfunctionOct 13, 2021Break; Break
ACCORDING TO THE REPORTER, DURING AN OPEN CORONARY ARTERY BYPASS GRAFT, WHILE CLOSING THE STERNOTOMY, THE STEEL NEEDLE BROKE. ANOTHER STEEL SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12629000 ↗MalfunctionMar 23, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING AN OPEN CARDIOVASCULAR PROCEDURE, THE NEEDLE AND THREAD BROKE ON THREE DEVICES. THE NEEDLE ALSO DETACHED FROM THE SUTURE. THE SURGICAL TIME WAS EXTENDED TO 30 MINUTES OR MORE. NEW PRODUCTS WERE USED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11558950 ↗MalfunctionJan 18, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, ON AN OPEN PROCEDURE FOR AORTIC ANEURYSM, AT THE END OF THE SURGERY, THE NEEDLE AND THREAD OF TWO DEVICES BROKE OFF. ANOTHER DEVICE FROM ANOTHER MANUFACTURER WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11185090 ↗MalfunctionSep 25, 2020Break; Break
ACCORDING TO THE REPORTER, DURING STERNUM CLOSURE FOR CORONARY ARTERY BYPASS GRAFTING (CABG), THE WIRE BROKE ON 8-9 SUTURES. ANOTHER DEVICE FROM A DIFFERENT MANUFACTURER WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 10584846 ↗MalfunctionMar 10, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING CORONARY ARTERY BYPASS, UPON STERNUM CLOSING, THE NEEDLE AND THE WIRE BREAK THROUGH THE JUNCTION. THE OPERATION TIME IS EXTENDED. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9814912 ↗MalfunctionFeb 5, 2020Break; Break
ACCORDING TO THE REPORTER DURING A CORONARY ARTERY BYPASS GRAFTING, WHILE TRYING TO COMBINE THE RIBS WHILE USING A CONTINUOUS SUTURING TECHNIQUE, THE NEEDLE OF THE DEVICE BROKE. ANOTHER PACKAGE WAS OPENED AND THE 2 OF THE NEEDLE IN THE PACKAGE ALSO BROKE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9673520 ↗MalfunctionFeb 5, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, ON AN OPEN CORONARY ARTERY BYPASS GRAFT, DURING THE COMBINATION OF THE RIBS, WHILE USING THE CONTINUOUS SUTURING TECHNIQUE, THREE NEEDLES BROKE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9670873 ↗MalfunctionApr 3, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING CORONARY ARTERY BYPASS GRAFTING, THE NEEDLES WERE DETACHED FROM THE SUTURES. THE ISSUE WAS RESOLVED IN ORDER TO COMPLETE THE CASE BY REPLACING THE SUTURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8478339 ↗
Other SUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE devices
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- 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
- ETHICON M649GEthicon, LLC · SUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE36 reports
- ETHIBOND EXCEL X523HEthicon, LLC · SUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE26 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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