Surgipro CP-414Recalls & 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
- 9
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10884521036147), received between Apr 17, 2023 and Mar 13, 2026 — classified as 9 malfunctions.
The most frequently reported specific device problem is “Break” (6 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
- Break6
- Material Protrusion/Extrusion2
- Device Slipped1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- Insufficient Information4
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 13, 2026Break
IT WAS REPORTED THAT DURING HERNIA SUTURING, THE SUTURE BROKE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24596249 ↗MalfunctionMar 13, 2026Break
IT WAS REPORTED THAT DURING A PROCEDURE, WHILE SUTURING, THE SUTURE BROKE IN THE MIDDLE. AN ADDITIONAL NEW SUTURE WAS 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 24591866 ↗MalfunctionJan 13, 2026Material Protrusion/Extrusion
IT WAS REPORTED THAT DURING OPEN INGUINAL HERNIA REPAIR, THE NEEDLE FRAYED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24064352 ↗MalfunctionJan 13, 2026Material Protrusion/Extrusion
IT WAS REPORTED THAT INTRAOPERATIVELY, THE NEEDLE FRAYED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24064305 ↗MalfunctionNov 20, 2024Break; Break
ACCORDING TO THE REPORTER, THE SUTURE WAS BROKEN.
Patient problems: Insufficient Information
MAUDE report 20735200 ↗MalfunctionNov 13, 2024Break; Break
ACCORDING TO THE REPORTER, THE SUTURE WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20677486 ↗MalfunctionNov 13, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SUTURE BROKE.
Patient problems: Insufficient Information
MAUDE report 20674708 ↗MalfunctionNov 11, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SUTURE KEPT ON BREAKING.
Patient problems: Insufficient Information
MAUDE report 20654081 ↗MalfunctionApr 17, 2023Device Slipped; Device Slipped
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE SURGEON PLACED 10 KNOTS AND WITHIN SECONDS THE KNOTS CAME UNDONE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 16755277 ↗
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
Other SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE devices
- PROLENE 8706HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE2 recalls294 reports
- PROLENE 8702HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE3 deaths254 reports
- PROLENE 8556HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 death240 reports
- PROLENE 8805HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 death209 reports
- PROLENE 8521HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE3 deaths183 reports
- PROLENE 8735HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE163 reports
- 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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