Surgipro VP-834Recalls & reported problems
Covidien LP · Monofilament Polypropylene · Class 2 · Implant
All models of Surgipro (62)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521039353), received between Mar 30, 2020 and Mar 27, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (3 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break3
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 27, 2025Break; Break
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE INVOLVING THE SURGIPRO* 0 BLU 75CM V20 X36 SUTURE, THE SUTURE BROKE IN THE MIDDLE WHILE SUTURING WITH TWO SUTURES, LEADING TO EXTENDED SURGICAL TIME. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THE PATIENT OUTCOME WAS REPORTED AS ALIVE WITH NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21710438 ↗MalfunctionMar 27, 2025Break; Break
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE INVOLVING THE SURGIPRO* 0 BLU 75CM V20 X36 SUTURE, THE SUTURE BROKE IN THE MIDDLE WHILE SUTURING WITH TWO SUTURES, LEADING TO EXTENDED SURGICAL TIME. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THE PATIENT OUTCOME WAS REPORTED AS ALIVE WITH NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21710424 ↗MalfunctionMay 15, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC UTERINE SUSPENSION, RIGHT SALPINGECTOMY, ANTERIOR AND POSTERIOR VAGINAL REPAIRS, WHEN SUTURING, THE SUTURE MATERIAL BEGAN TO SHEAR. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19322821 ↗MalfunctionMar 30, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE NEEDLE AND THREAD DIVERGED PRIOR TO USE. A NEW SUTURE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9899285 ↗
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
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- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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