Surgipro ll SP-5663Recalls & 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
- 14
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10884521036819), received between Sep 25, 2017 and Mar 13, 2025 — classified as 14 malfunctions.
The most frequently reported specific device problem is “Break” (9 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.
Reports received per month
Most reported problems
Device problems
- Break9
- Detachment of Device or Device Component5
- Adverse Event Without Identified Device or Use Problem1
- Detachment Of Device Component1
- Unraveled Material1
Patient problems
- No Consequences Or Impact To Patient6
- No Clinical Signs, Symptoms or Conditions5
- No Known Impact Or Consequence To Patient4
- Wound Dehiscence2
- No Code Available1
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 13, 2025Unraveled Material; Unraveled Material
ACCORDING TO THE REPORTER, ON (B)(6) 2025 THE PATIENT UNDERWENT A NARROW LUMBAR CANAL DECOMPRESSION, A WOUND CLOSURE ON THE SKIN WITH A NON-ABSORBABLE SUTURE WAS USED. ON (B)(6) 2025, THE SUTURE LINE DID NOT HOLD AND THE PATIENT HAD APPARENT WOUND DEHISCENCE.
Patient problems: Wound Dehiscence
MAUDE report 21598768 ↗MalfunctionOct 24, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, AT THE MOMENT OF SKIN CLOSURE, THE NEEDLE WAS DISASSEMBLED FROM THE THREAD, A NEW SUTURE WAS OPENED AND IT UNRAYS BECOMING A DOUBLE THREAD. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20522258 ↗MalfunctionJun 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, THE WOUND OF THE PATIENT OPENED.
Patient problems: Wound Dehiscence
MAUDE report 19460799 ↗MalfunctionMay 10, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, PRE-OPERATIVELY, AT THE MOMENT OF PASSING THE SUTURE FOR USE, THE NEEDLE WAS DISASSEMBLED FROM THE SUTURE STRAND. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11802328 ↗MalfunctionOct 31, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC VENTRAL HERNIORRHAPHY, ON MESH FIXATION, THE THREAD BROKE AND FELL INTO THE PATIENT'S CAVITY THEN WAS RETRIEVED. THE SURGICAL TIME WAS EXTENDED BY 30 MINUTES OR MORE. THE MESH HAD TO BE RE-POSITIONED AND FIXED AGAIN USING A NEW SUTURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Code Available; No Consequences Or Impact To Patient
MAUDE report 10767193 ↗MalfunctionAug 11, 2020Break; Break
ACCORDING TO THE REPORTER, DURING ORTHOPEDIC PROCEDURE, WHILE DOING CONTINUOUS SUTURE, THE THREAD OF THE DEVICE BROKE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 10393451 ↗MalfunctionAug 7, 2020Break; Break
ACCORDING TO THE REPORTER, DURING UTERUS CLOSURE DURING CESAREAN PROCEDURE, WHILE DOING CONTINUOUS SUTURE, THE THREAD OF THE DEVICE BROKE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 10377960 ↗MalfunctionMar 24, 2020Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN THE SPECIALIST WAS FACING THE SKIN, THE SUTURE WAS DIVIDED IN HALF. ANOTHER SUTURE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9875718 ↗MalfunctionMar 24, 2020Break; Break
ACCORDING TO THE REPORTER, ON AN OPEN UMBILICAL HERNIA PROCEDURE WITH OBSTRUCTION, DURING THE KNOTTING, THE THREAD OF TWO DEVICES BROKE. THE TECHNIQUE WAS REPEATED AND SURGICAL TIME WAS EXTENDED. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9874372 ↗MalfunctionOct 18, 2019Break; Break
ACCORDING TO THE REPORTER, DURING SKIN CLOSURE AT THE SECOND GAP OF A UMBILICAL HERNIORRHAPHY, THE THREAD BROKE. THE SUTURE TORN APART AND DIVIDED INTO SEVERAL STRANDS. ANOTHER SUTURE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9209168 ↗MalfunctionJan 8, 2019Break; Break
ACCORDING TO THE REPORTER, DURING TUBAL LIGATION PROCEDURE, WHILE ON THE END, THE DEVICE THREAD BROKE. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8227595 ↗MalfunctionJul 31, 2018Break; Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, WHEN THE DOCTOR WAS SUTURING DURING AN OPEN PROCEDURE, THE SUTURE BROKE DOWN IN THE ANCHOR. ANOTHER SUTURE WAS BROKEN WHEN KNOTTED. THIS CAUSED MORE EXPENSE OF SUPPLIES AND MORE SURGICAL TIME NOT MORE THAN 30 MINUTES. THEY USED ANOTHER SUTURE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7735700 ↗MalfunctionMar 22, 2018Break; Detachment Of Device Component; Break; Detachment Of Device Component
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC COLECTOMY, WHILE CLOSING THE SKIN TOWARDS THE END OF THE PROCEDURE, THE TIP OF THE NEEDLE BROKE AND WAS RETRIEVED. THEY USED ANOTHER SUTURE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7362268 ↗MalfunctionSep 25, 2017Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SKIN CLOSURE, THE SURGEON WAS CLOSING THE SKIN WHEN THE DEVICE'S NEEDLE SEPARATED FROM THE THREAD, THEY USED A NEW ADDITIONAL SUTURE WITHOUT ANY ISSUE. THE PATIENT WAS ALIVE WITH NO INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6891563 ↗
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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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