Surgipro VP-833Recalls & 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
- 13
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10884521039315), received between Jul 26, 2017 and Mar 17, 2025 — classified as 1 injury, 12 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (7 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 Component7
- Break6
- Material Twisted/Bent2
- Detachment Of Device Component1
- Difficult to Open or Remove Packaging Material1
Patient problems
- No Known Impact Or Consequence To Patient6
- Insufficient Information2
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient1
- No Patient Involvement1
- Radiation Exposure, Unintended1
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 17, 2025Detachment of Device or Device Component; Material Twisted/Bent; Detachment of Device or Device Component; Material Twisted/Bent
IT WAS REPORTED THAT DURING A PROCEDURE, WHILE SUTURING THE TISSUE INVOLVING THE SUTURE, THE TWO NEEDLES BENT AND POPPED OFF FROM THE SUTURE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE AND COMPLETE THE CASE.
Patient problems: Insufficient Information
MAUDE report 21620922 ↗MalfunctionMar 17, 2025Detachment of Device or Device Component; Material Twisted/Bent; Detachment of Device or Device Component; Material Twisted/Bent
IT WAS REPORTED THAT DURING A PROCEDURE, WHILE SUTURING THE TISSUE INVOLVING THE SUTURE, THE TWO NEEDLES BENT AND POPPED OFF FROM THE SUTURE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE AND COMPLETE THE CASE.
Patient problems: Insufficient Information
MAUDE report 21620490 ↗MalfunctionNov 21, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, WHILE REMOVING THE DEVICE FROM THE PORT AFTER SUTURING, THE NEEDLE DETACHED. NO DEVICE COMPONENT FELL INTO THE PATIENT¿S CAVITY. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20747275 ↗MalfunctionOct 18, 2021Break; Break
ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE NEEDLE BROKE. ANOTHER SUTURE WAS USED TO CONTINUE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12647845 ↗MalfunctionSep 15, 2019Break; Break
ACCORDING TO THE REPORTER, DURING TRANSANAL RESECTION PROCEDURE, ON CREATION OF A PURSE-STRING SUTURE, THE THREAD BROKE. USED DIFFERENT SUTURE TO COMPLETE THE PROCEDURE THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9068051 ↗MalfunctionMar 6, 2019Break; Break
ACCORDING TO THE REPORTER, PRIOR TO GASTROINTESTINAL PROCEDURE, THE DEVICE WIRE BREAK. THEY THEN USED ANOTHER SUTURE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8394351 ↗MalfunctionFeb 3, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PARTIAL GASTRECTOMY PROCEDURE, THE NEEDLE AND THREAD WERE FOUND TO BE DISCONNECTED WHEN THE PACKAGE WAS OPENED AND BEFORE THE SUTURE WAS PULLED OUT. THE PRODUCT WAS NOT USED ON THE PATIENT AND A NEW ONE WAS OPENED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8300581 ↗MalfunctionDec 27, 2018Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING AN ABDOMINAL WALL HERNIA PROCEDURE, THE DEVICE THREAD DISENGAGED FROM THE NEEDLE EASILY. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8201326 ↗MalfunctionDec 18, 2018Break; Break
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC COLON PROCEDURE, WHILE PERFORMING A CONTINUOUS KNOT TECHNIQUE, THE SUTURE IS BROKEN/RUPTURED. THE RUPTURE OCCURRED WHILE CLOSING THE SOFT TISSUE. THEY USED ANOTHER DEVICE TO COMPLETE THE CASE. NO PATIENT HARM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8174955 ↗InjuryMar 1, 2018Detachment Of Device Component; Detachment of Device or Device Component; Detachment Of Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE NEEDLE DETACHED FROM THE THREAD AND FELL INTO THE PATIENT'S CAVITY. IT WAS RETRIEVED WITH THE USE OF X-RAY. THERE WAS NO PATIENT INJURY.
Patient problems: Radiation Exposure, Unintended
MAUDE report 7306967 ↗MalfunctionDec 21, 2017Break; Difficult to Open or Remove Packaging Material; Break; Difficult to Open or Remove Packaging Material
ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE THREAD BROKE AS THE NURSE WAS LOADING THE NEEDLE AND THE SUTURE WOULD NOT COME OUT OF PACKAGE EASILY AND REQUIRED FORCE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Patient Involvement
MAUDE report 7140990 ↗MalfunctionAug 10, 2017Break; Break
ACCORDING TO THE REPORTER, THE LOOP BROKE. THERE WAS NO PATIENT INJURY INVOLVED REGARDING THE EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED. THE SALES REP WILL FOLLOW-UP.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6787312 ↗MalfunctionJul 26, 2017Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER: OCCURRED DURING AN OPEN PROCEDURE. UPON FIRST PASSING THROUGH THE TISSUE, THE NEEDLE DETACHED FROM THE SUTURE. THE SUTURE WASN'T TREATED OR HYDRATED PRIOR TO USE. A NEW SUTURE WAS USED TO COMPLETE THE PROCEDURE WITH NO ISSUE. THE PATIENT IS ALIVE WITH NO INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6744046 ↗
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 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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