Surgipro SP-631Recalls & 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
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521037083), received between Dec 5, 2018 and Mar 5, 2019 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Break” (4 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.
Most reported problems
Device problems
- Break4
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Consequences Or Impact To Patient2
- No Known Impact Or Consequence To Patient1
- Tissue Damage1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 5, 2019Break; Break
ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE THREAD BROKE, THE EVENT OCCURRED IN 3 SUTURES USED IN THIS PROCEDURE. THEY REPLACED THE SUTURE TO COMPLETE THE CASE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8390147 ↗MalfunctionMar 5, 2019Break; Break
ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE THREAD BROKE, THE EVENT OCCURRED IN 3 SUTURES USED IN THIS PROCEDURE. THEY REPLACED THE SUTURE TO COMPLETE THE CASE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8390144 ↗InjuryDec 26, 2018Break; Break
ACCORDING TO THE REPORTER, DURING AN PEN PROCEDURE, THE NEEDLE GOT TWISTED AT THE TIP. IT WAS NOTED THAT THERE WAS TISSUE TRAUMA. TO COMPLETE THE CASE, ANOTHER SUTURE WAS USED. THERE WAS PATIENT INJURY.
Patient problems: Tissue Damage
MAUDE report 8198055 ↗MalfunctionDec 5, 2018Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE THREAD BROKE, THEY REPLACED THE SUTURE TO COMPLETE THE CASE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8133171 ↗
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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