Surgipro II VP-762-XRecalls & reported problems
Covidien LP · Monofilament Polypropylene · Class 2 · Implant
All models of Surgipro II (73)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521039155), received between Jun 26, 2018 and Jun 25, 2026 — classified as 1 injury, 4 malfunctions.
The most frequently reported specific device problem is “Break” (4 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break4
- Detachment of Device or Device Component2
- Dull, Blunt1
Patient problems
- Insufficient Information3
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 25, 2026Break; Dull, Blunt
IT WAS REPORTED THAT INTRAOPERATIVELY, WHILE SUTURING, ABOUT FOUR SUTURES HAD DULL NEEDLE. THE NEEDLE OF ONE OF THE SUTURES ALSO BROKE AND FELL INTO THE PATIENT. THE NEEDLE PIECE WAS RETRIEVED. ANOTHER SUTURE FROM A DIFFERENT LOT NUMBER WAS USED TO RESOLVE THE ISSUE.
Patient problems: Insufficient Information
MAUDE report 25622595 ↗MalfunctionMar 19, 2026Break
ACCORDING TO THE REPORTER, DURING A HEMORRHOIDOPEXY, THE NON-ABSORBABLE MONOFILAMENT POLYPROPYLENE SUTURE WAS USED TO SUTURE THE RECTAL MUCOSA, AND THE NEEDLE BROKE. TO RESOLVE THE ISSUE, THE BROKEN NEEDLE WAS REMOVED, AND THE SURGERY PROCEEDED AS NORMAL.
Patient problems: Insufficient Information
MAUDE report 24644523 ↗InjuryApr 17, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING AN OPEN LIVER TRANSPLANT SURGERY, IN SUTURING THE SUPERIOR VENA CAVA USING A CONTINUOUS STITCHING TECHNIQUE, THE NEEDLE TIP OF DEVICE BROKE. THE TIP FELL IN THE CAVITY AND THE SURGEON SPENDS MORE TIME TO LOOK FOR THE BROKEN TIP, BUT COULD NOT FIND IT BECAUSE THE NEEDLE TIP WAS TOO SMALL, SO IT WAS NOT REMOVED. THE SURGERY WAS PROLONGED FOR MORE THAN 30 MINUTES.
Patient problems: Foreign Body In Patient
MAUDE report 19124542 ↗MalfunctionDec 19, 2022Break; Break
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE NEEDLE BROKE. THE NEEDLE WAS SPLIT IN TWO DOWN THE MIDDLE UPON OPENING. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 16010373 ↗MalfunctionJun 26, 2018Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, PRE-OPERATIVELY, AS SOON AS THE NEEDLE WAS GRASPED BY THE NEEDLE HOLDER, THE NEEDLE DETACHED FROM THE THREAD. A NEW DEVICE WAS USED TO COMPLETE THE CASE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7638064 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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