Surgipro SP-675Recalls & reported problems
Covidien LP · Monofilament Polypropylene · Class 2 · Implant
All models of Surgipro (62)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 22
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10884521037441), received between Mar 6, 2018 and Nov 3, 2025 — classified as 22 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (18 reports).
1 other recall cover devices cleared under the same FDA submission (K954808); they may or may not involve this specific model.
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component18
- Break4
- Insufficient Device Problem Information2
- Component Missing1
Patient problems
- No Consequences Or Impact To Patient8
- No Clinical Signs, Symptoms or Conditions5
- No Information4
- No Patient Involvement3
- Insufficient Information2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT PRE-OPERATIVELY, WHILE BEING REMOVED FROM THE RETAINER AND PREPARED PRIOR TO PATIENT INCISION, THREE PACKETS OF SUTURES WERE FOUND TO HAVE NEEDLES DETACHED. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23459284 ↗MalfunctionNov 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT PRE-OPERATIVELY, WHILE BEING REMOVED FROM THE RETAINER AND PREPARED PRIOR TO PATIENT INCISION, THREE PACKETS OF SUTURES WERE FOUND TO HAVE NEEDLES DETACHED. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23459157 ↗MalfunctionNov 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT PRE-OPERATIVELY, WHILE BEING REMOVED FROM THE RETAINER AND PREPARED PRIOR TO PATIENT INCISION, THREE PACKETS OF SUTURES WERE FOUND TO HAVE NEEDLES DETACHED. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23459090 ↗MalfunctionJun 23, 2021Break; Break
ACCORDING TO THE REPORTER, DURING AN OPEN THYROID PROCEDURE, WHEN CLOSING THE SKIN, THE DEVICE'S THREAD BROKE. THE SURGEON THEN USED ANOTHER DEVICE 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 12053722 ↗MalfunctionMay 10, 2021Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information
ACCORDING TO THE REPORTER, THE COMPLAINT WAS CREATED IN ERROR.
Patient problems: Insufficient Information
MAUDE report 11797230 ↗MalfunctionMay 5, 2021Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE DETACHED FROM THE THREAD AS A WHOLE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE.
Patient problems: Insufficient Information
MAUDE report 11778288 ↗MalfunctionFeb 23, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, AT THE START OF THE VETERINARY OPERATION, THE DEVICE WAS TOOK OUT OF THE PACKAGING AND IT WAS NOTICED THAT THE NEEDLE HAD CAME OFF THE THREAD AND IT WAS NOT USED. A DIFFERENT SUTURE WAS USED THAT DID NOT SHOW THIS PROBLEM. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11368845 ↗MalfunctionMar 30, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING SKIN CLOSURE, WHEN THE NEEDLE WAS HELD BY THE SUTURE HOLDER, THE NEEDLE AND SUTURE DIVERGED BEFORE SUTURING. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9899748 ↗MalfunctionFeb 24, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING LUMP REMOVAL AND DE-SEXING A DOG, THE NEEDLE PART KEPT DETACHING FROM THE THREAD ON MULTIPLE OCCASIONS. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9744615 ↗MalfunctionFeb 24, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
MalfunctionJan 28, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE NEEDLE DETACHED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE.
Patient problems: No Information; No Patient Involvement
MAUDE report 9637650 ↗MalfunctionDec 9, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, PRIOR TO A PROCEDURE, THE DEVICE'S NEEDLE HAS COME OFF THE THREAD. THE NEEDLE WAS ALREADY IN THE PACKAGING NEXT TO THE THREAD. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Patient Involvement
MAUDE report 9439273 ↗MalfunctionOct 23, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, WHEN SUTURING THE SKIN INTRA-OPERATIVELY, THE NEEDLE CUTTING OFF FROM THE SUTURE THREAD. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9227242 ↗MalfunctionOct 17, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, THE NEEDLE WAS FOUND OFF THE SUTURE UPON OPENING THE DEVICE. THE DEVICE WAS NOT USED ON ANY PATIENT. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9205502 ↗MalfunctionSep 5, 2019Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE ON WOUND CLOSURE, THE DEVICE'S NEEDLE BROKE. A NEW DEVICE WAS USED TO COMPLETE THE CASE.
Patient problems: No Information
MAUDE report 8966685 ↗MalfunctionAug 1, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ACCORDING TO THE REPORTER DURING A OPEN PROCEDURE WHEN SUTURING, THE THREAD OF THE DEVICE BROKE AND THE SUTURE CAME OFF THE NEEDLE. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8853497 ↗MalfunctionJul 26, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, THE THREE SUTURES WERE COMING OFF THE NEEDLE AND KEEPS BREAKING OFF THE NEEDLE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8830881 ↗MalfunctionJul 26, 2019Break; Break
ACCORDING TO THE REPORTER, THE SUTURE CAME OFF AND KEPT ON BREAKING OFF THE NEEDLE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Information
MAUDE report 8830792 ↗MalfunctionMay 20, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING AN OPEN BYPASS PROCEDURE, WHILE SKIN SUTURING, THE NEEDLE SEPARATED FROM THE STRAND AFTER TAKING THE SUTURE FROM THE PACKAGE. IT HAPPENED ABOUT 10 TIMES WITH THE SAME SUTURE AND SAME PROCEDURE. THE ANOTHER SUTURE FROM THE SAME PACKAGE WAS TAKEN TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8625707 ↗MalfunctionMar 26, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING OPEN AORTIC VALVE REPLACEMENT PROCEDURE, WHILE CLOSING THE SKIN, THE THREAD WERE SEPARATED FROM THE NEEDLE. ANOTHER ONE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8451764 ↗MalfunctionMar 26, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING AN OPEN BYPASS CARDIO SURGERY, WHILE CLOSING THE SKIN, THE THREAD SEPARATED FROM THE NEEDLE. A NEW DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8451609 ↗MalfunctionMar 6, 2018Component Missing; Component Missing
ACCORDING TO THE REPORTER, PRE-OPERATIVELY, WHEN THE TECH WENT TO LOAD THE NEEDLE/SUTURE, THERE WAS NO NEEDLE IN THE PACKAGE. A NEW SUTURE WAS PULLED TO COMPLETE THE PROCEDURE. THIS ISSUE WAS NOTICED PRIOR TO USE AND THERE WAS NO PATIENT INVOLVED IN THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7316225 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K954808. One submission often covers many models, so check the product and lot details in each record.
- Z-1179-2023 · Dec 2, 2022 · Open, ClassifiedSurgipro Monofilament Polypropylene Sutures Product Description CP-535 SURGIPRO* 1 BLU 100CM GS24 X36 CP-824 SURGIPRO* 1 BLU 150CM GS26 X24 CP-825 SURGIPRO* 2 BLU 150CM GS26 X24 VP
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- PROLENE 8711HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 recall89 reports
- PROLENE 9702HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE130 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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