Surgipro ll SP-5699Recalls & reported problems
Covidien LP · Monofilament Polypropylene · Class 2 · Implant
All models of Surgipro ll (70)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10884521037014), received between Jul 19, 2017 and Jan 9, 2023 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (7 reports).
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
- Detachment of Device or Device Component7
- Break3
- Detachment Of Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- No Known Impact Or Consequence To Patient3
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 9, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE DEVICE BROKE AT THE JUNCTION BETWEEN THE SUTURE AND THE NEEDLE. A NEW DEVICE WITH A DIFFERENT LOT NUMBER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16125182 ↗MalfunctionOct 11, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, DOING FINGER SUTURING AT THE EMERGENCY ROOM (ER), THE SUTURE BROKE AT THE JUNCTION BETWEEN THE SUTURE AND THE NEEDLE SWAGE, 3 CONSECUTIVE TIMES WITH THE SAME LOT. TO RESOLVE THE ISSUE, THE SUTURE WAS DONE WITH ANOTHER LOT NUMBER IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15577440 ↗MalfunctionFeb 19, 2021Break; Break
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, DURING DEVICE PREPARATION, THE DEVICE THREAD BROKE. THE SURGEON THEN USED ANOTHER DEVICE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11349538 ↗MalfunctionFeb 19, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, PRE-OPERATIVELY, ON PREPARATION, THE NEEDLE DISENGAGED FROM THE THREAD DURING PREPARATION, MAKING IT UNUSABLE. ANOTHER NEW SUTURE WAS USED WITHOUT AN ISSUE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11348986 ↗MalfunctionAug 5, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING VIDEO-ASSISTED THYROIDECTOMY, AFTER OPENING THE PACKAGE AND PRODUCT WAS TRIED TO BE TAKEN OUT OF THE PACKAGE, THE NEEDLE CAME OFF. THE PRODUCT WAS NOT USED FOR PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10370931 ↗MalfunctionJul 19, 2017Detachment 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 WHEN SUTURING A THUMB WOUND, THE NEEDLE DETACHED FROM THE THREAD AND FELL INTO THE THUMB OF THE PATIENT. IT TOOK THE DOCTOR 10 MINUTES TO FIND AND RETRIEVE THE DISENGAGED NEEDLE FROM THE WOUND. A NEW SUTURE WAS USED IN ORDER TO COMPLETE THE CASE. THE PATIENT STATUS IS ALIVE WITH NO INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6725978 ↗MalfunctionJul 19, 2017Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, THE DEVICE'S NEEDLE BROKE AWAY FROM THREAD. THIS WAS THE THIRD INCIDENT WITH THE SAME LOT NUMBER IN THE HOSPITAL.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6725957 ↗MalfunctionJul 19, 2017Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, WHILE SUTURING A LEG WOUND, THE NEEDLE DETACHED FROM THE THREAD TWICE DURING THE SAME PROCEDURE. ANOTHER DEVICE WAS USED IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY INVOLVED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6725706 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page