Surgipro ll VP-713-XRecalls & reported problems
Covidien LP · Monofilament Polypropylene · Class 2 · Implant
All models of Surgipro ll (70)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 22
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10884521038455), received between Apr 25, 2017 and Sep 15, 2026 — classified as 1 injury, 21 malfunctions.
The most frequently reported specific device problem is “Break” (20 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
- Break20
- Adverse Event Without Identified Device or Use Problem1
- Detachment of Device or Device Component1
- Material Frayed1
- Product Quality Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions14
- No Known Impact Or Consequence To Patient3
- Insufficient Information1
- No Code Available1
- No Consequences Or Impact To Patient1
- No Information1
- No Patient Involvement1
Recent adverse event reports
The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 15, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50782246 ↗MalfunctionSep 16, 2022Break; Break
ACCORDING TO THE REPORTER, DURING ARTERIOVENOUS FISTULA ANGIOPLASTY FOR STAGE 5 CHRONIC KIDNEY DISEASE, WHEN THE DOCTOR USED THE SUTURE NEEDLE TO SUTURE THE PATIENT'S WOUND NORMALLY, AFTER OPENING THE OUTER PACKAGE, THE NEEDLE WAS FOUND TO BE BROKEN AND COULD NOT BE USED. ANOTHER SUTURE NEEDLE WAS USED TO RESOLVE THE ISSUE, DELAYING THE SMOOTH PROGRESS OF THE WOUND SUTURE AFTER THE PATIENT'S OPERATION.
Patient problems: Insufficient Information
MAUDE report 15441789 ↗MalfunctionJun 24, 2022Break; Break
ACCORDING TO THE REPORTER, DURING DOUBLE EYELID INCISION, WHEN THE SOFT TISSUE OF THE UPPER EYELID WAS SUTURED, TWELVE SUTURE NEEDLES WERE BROKEN. THE ACCOUNT LOOKED FOR THE BROKEN NEEDLES AND REPLACED WITH ANOTHER SUTURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14809620 ↗MalfunctionJun 24, 2022Break; Break
ACCORDING TO THE REPORTER, DURING DOUBLE EYELID INCISION, WHEN THE SOFT TISSUE OF THE UPPER EYELID WAS SUTURED, TWELVE SUTURE NEEDLES WERE BROKEN. THE ACCOUNT LOOKED FOR THE BROKEN NEEDLES AND REPLACED WITH ANOTHER SUTURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14809472 ↗MalfunctionJun 24, 2022Break; Break
ACCORDING TO THE REPORTER, DURING DOUBLE EYELID INCISION, WHEN THE SOFT TISSUE OF THE UPPER EYELID WAS SUTURED, TWELVE SUTURE NEEDLES WERE BROKEN. THE ACCOUNT LOOKED FOR THE BROKEN NEEDLES AND REPLACED WITH ANOTHER SUTURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14809420 ↗MalfunctionJun 24, 2022Break; Break
ACCORDING TO THE REPORTER, DURING DOUBLE EYELID INCISION, WHEN THE SOFT TISSUE OF THE UPPER EYELID WAS SUTURED, TWELVE SUTURE NEEDLES WERE BROKEN. THE ACCOUNT LOOKED FOR THE BROKEN NEEDLES AND REPLACED WITH ANOTHER SUTURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14809138 ↗MalfunctionJun 24, 2022Break; Break
ACCORDING TO THE REPORTER, DURING DOUBLE EYELID INCISION, WHEN THE SOFT TISSUE OF THE UPPER EYELID WAS SUTURED, TWELVE SUTURE NEEDLES WERE BROKEN. THE ACCOUNT LOOKED FOR THE BROKEN NEEDLES AND REPLACED WITH ANOTHER SUTURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14800309 ↗MalfunctionJun 24, 2022Break; Break
ACCORDING TO THE REPORTER, DURING DOUBLE EYELID INCISION, WHEN THE SOFT TISSUE OF THE UPPER EYELID WAS SUTURED, TWELVE SUTURE NEEDLES WERE BROKEN. THE ACCOUNT LOOKED FOR THE BROKEN NEEDLES AND REPLACED WITH ANOTHER SUTURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14800228 ↗MalfunctionJun 24, 2022Break; Break
ACCORDING TO THE REPORTER, DURING DOUBLE EYELID INCISION, WHEN THE SOFT TISSUE OF THE UPPER EYELID WAS SUTURED, TWELVE SUTURE NEEDLES WERE BROKEN. THE ACCOUNT LOOKED FOR THE BROKEN NEEDLES AND REPLACED WITH ANOTHER SUTURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14800131 ↗MalfunctionJun 24, 2022Break; Break
ACCORDING TO THE REPORTER, DURING DOUBLE EYELID INCISION, WHEN THE SOFT TISSUE OF THE UPPER EYELID WAS SUTURED, TWELVE SUTURE NEEDLES WERE BROKEN. THE ACCOUNT LOOKED FOR THE BROKEN NEEDLES AND REPLACED WITH ANOTHER SUTURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14800067 ↗MalfunctionJun 24, 2022Break; Break
ACCORDING TO THE REPORTER, DURING DOUBLE EYELID INCISION, WHEN THE SOFT TISSUE OF THE UPPER EYELID WAS SUTURED, TWELVE SUTURE NEEDLES WERE BROKEN. THE ACCOUNT LOOKED FOR THE BROKEN NEEDLES AND REPLACED WITH ANOTHER SUTURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14799925 ↗MalfunctionJun 24, 2022Break; Break
ACCORDING TO THE REPORTER, DURING DOUBLE EYELID INCISION, WHEN THE SOFT TISSUE OF THE UPPER EYELID WAS SUTURED, TWELVE SUTURE NEEDLES WERE BROKEN. THE ACCOUNT LOOKED FOR THE BROKEN NEEDLES AND REPLACED WITH ANOTHER SUTURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14799818 ↗MalfunctionJun 17, 2022Break; Break
ACCORDING TO THE REPORTER, DURING DOUBLE EYELID INCISION, WHEN THE SOFT TISSUE OF THE UPPER EYELID WAS SUTURED, TWELVE SUTURE NEEDLES WERE BROKEN. THE ACCOUNT LOOKED FOR THE BROKEN NEEDLES AND REPLACED WITH ANOTHER SUTURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14738845 ↗MalfunctionJun 17, 2022Break; Break
ACCORDING TO THE REPORTER, DURING DOUBLE EYELID INCISION, WHEN THE SOFT TISSUE OF THE UPPER EYELID WAS SUTURED, TWELVE SUTURE NEEDLES WERE BROKEN. THE ACCOUNT LOOKED FOR THE BROKEN NEEDLES AND REPLACED WITH ANOTHER SUTURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14738763 ↗MalfunctionJun 7, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING VASCULAR ANASTOMOSIS ON CORONARY ARTERY BYPASS, THE PRODUCT CAME OUT OF THE BAG WITH SUTURE AND NEEDLE SEPARATED. SURGEON USED SAME PRODUCT WITH DIFFERENT LOT TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11952053 ↗InjuryMar 22, 2020Break; Product Quality Problem; Break; Product Quality Problem
ACCORDING TO THE REPORTER, DURING A VALVE SURGERY, IN THE MIDDLE AND END OF THE PROCEDURE, THE NEEDLE AND THREAD BROKE ON THE SIX DEVICES. THE SURGICAL TIME WAS EXTENDED BY THIRTY MINUTES OR MORE. THE INCISION WAS EXTENDED BY MORE THAN 2.54CM. THE STITCH MEMORY WAS OUT OF THE PACKAGE WITH DEFECTIVE MEMORY. THE PRODUCTS HAVE BEEN CHANGED TO COMPLETE THE CASE.
Patient problems: No Code Available
MAUDE report 9863700 ↗MalfunctionDec 12, 2019Break; Material Frayed; Break; Material Frayed
ACCORDING TO THE REPORTER, DURING A VASCULAR SURGERY OPEN PROCEDURE, THE THREAD WAS BROKEN AND FRAYED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9463481 ↗MalfunctionApr 10, 2019Break; Break
ACCORDING TO THE REPORTER, WHEN THE ANASTOMOSIS WAS BEING DONE IN A KIDNEY TRANSPLANT RECIPIENT, THE THREAD BROKE. SURGICAL TIME EXTENDED MORE THAN 30 MINUTES JUST TO DO THE ANASTOMOSIS. THEY USE THE SUTURE UNTIL FINE ONE. THERE WAS NO PATIENT INJURY.
Patient problems: No Information
MAUDE report 8499195 ↗MalfunctionFeb 20, 2019Break; Break
ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE NEEDLE WAS BROKEN. NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8354079 ↗MalfunctionJun 29, 2018Break; Break
ACCORDING TO THE REPORTER, DURING A CORONARY ARTERY BYPASS GRAFT, THE THREAD BROKE IN RUNNING SUTURING TECHNIQUE. THEY USED A NEW SUTURE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7652785 ↗MalfunctionDec 4, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, DURING CABG PROCEDURE SUTURES WERE BREAKING AND ONE OF THE NEEDLES BROKE IN HALF. THERE WAS NO INJURY TO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7079689 ↗MalfunctionApr 25, 2017Break; Break
ACCORDING TO THE REPORTER, DURING CABG PROCEDURE SUTURES WERE BREAKING AND ONE OF THE NEEDLES BROKE IN HALF. NO PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6519873 ↗
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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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