Surgipro II VP-73-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
Quick summary
This Covidien Surgipro II VP-73-X is a non-absorbable polypropylene surgical suture sold on a detachable needle. Most of the 57 reports describe the suture breaking during surgery or the needle coming off the suture thread; in several cases staff confirmed no fragments were left in the wound and the procedure was finished with a different suture. No deaths and no injuries were reported, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 57
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 10884521038868), received between Sep 20, 2018 and Nov 18, 2025 — classified as 57 malfunctions.
The most frequently reported specific device problem is “Break” (34 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
- Break34
- Detachment of Device or Device Component29
- Adverse Event Without Identified Device or Use Problem3
Patient problems
- No Clinical Signs, Symptoms or Conditions20
- Insufficient Information19
- No Consequences Or Impact To Patient10
- No Known Impact Or Consequence To Patient6
- No Information3
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 57 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 18, 2025Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE TIP BROKE. THE SURGEON, CIRCULATING NURSE, AND SCRUB NURSE PROMPTLY INSPECTED THE BROKEN NEEDLE AND CONFIRMED THAT NO FRAGMENTS WERE LEFT IN THE PATIENT'S WOUND. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23584315 ↗MalfunctionSep 9, 2025Break; Break
ACCORDING TO THE REPORTER DURING THE SCALP TUMOR RESECTION, THE SUTURE NEEDLE BROKE WHILE SUTURING THE INCISION. THE BROKEN NEEDLE WAS LOCATED AND REMOVED BY THE OPERATING SURGEON. THE CIRCULATING NURSE AND INSTRUMENT NURSE CONFIRMED THE INTEGRITY OF THE BROKEN NEEDLE TO ENSURE NO FRAGMENTS WERE LEFT INSIDE THE PATIENT'S WOUND. A DIFFERENT MODEL OF SUTURE WAS USED TO COMPLETE THE INCISION CLOSURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23001882 ↗MalfunctionJun 10, 2025Break; Break
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC TOTAL HYSTERECTOMY WITH BILATERAL ADNEXECTOMY AND PELVIC LYMPH NODE DISSECTION, THE SUTURE NEEDLE BROKE DURING THE SUTURING PROCESS. THE SURGICAL TEAM PROMPTLY REPLACED THE DEFECTIVE SUTURE, SUCCESSFULLY COMPLETING THE PROCEDURE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22176558 ↗MalfunctionSep 17, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE TWELVE NEEDLE DETACHED.
Patient problems: Insufficient Information
MAUDE report 20239618 ↗MalfunctionSep 17, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE TWELVE NEEDLE DETACHED.
Patient problems: Insufficient Information
MAUDE report 20239600 ↗MalfunctionSep 17, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE TWELVE NEEDLE DETACHED.
Patient problems: Insufficient Information
MAUDE report 20239563 ↗MalfunctionSep 17, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE TWELVE NEEDLE DETACHED.
Patient problems: Insufficient Information
MAUDE report 20239283 ↗MalfunctionSep 17, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE TWELVE NEEDLE DETACHED.
Patient problems: Insufficient Information
MAUDE report 20239080 ↗MalfunctionSep 17, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE TWELVE NEEDLE DETACHED.
Patient problems: Insufficient Information
MAUDE report 20239055 ↗MalfunctionSep 17, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE TWELVE NEEDLE DETACHED.
Patient problems: Insufficient Information
MAUDE report 20239044 ↗MalfunctionSep 17, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE TWELVE NEEDLE DETACHED.
Patient problems: Insufficient Information
MAUDE report 20239004 ↗MalfunctionSep 17, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE TWELVE NEEDLE DETACHED.
Patient problems: Insufficient Information
MAUDE report 20238977 ↗MalfunctionSep 17, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE TWELVE NEEDLE DETACHED.
Patient problems: Insufficient Information
MAUDE report 20237896 ↗MalfunctionSep 17, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE TWELVE NEEDLE DETACHED.
Patient problems: Insufficient Information
MAUDE report 20237829 ↗MalfunctionSep 17, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE TWELVE NEEDLE DETACHED.
Patient problems: Insufficient Information
MAUDE report 20237745 ↗MalfunctionSep 16, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE TWELVE NEEDLE DETACHED.
Patient problems: Insufficient Information
MAUDE report 20225953 ↗MalfunctionSep 16, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE TWELVE NEEDLE DETACHED.
Patient problems: Insufficient Information
MAUDE report 20225712 ↗MalfunctionSep 16, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE TWELVE NEEDLE DETACHED.
Patient problems: Insufficient Information
MAUDE report 20225503 ↗MalfunctionSep 16, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE TWELVE NEEDLE DETACHED.
Patient problems: Insufficient Information
MAUDE report 20225417 ↗MalfunctionMar 23, 2024Break; Break
ACCORDING TO THE REPORTER, DURING SUTURING IN A PROCEDURE, THE THREAD OF THE DEVICE BROKE.
Patient problems: Insufficient Information
MAUDE report 18966299 ↗MalfunctionNov 20, 2023Break; Break
ACCORDING TO THE REPORTER, DURING A PEDIATRIC ANTHROMBUS PROCEDURE, DIRECTOR ROUTINELY USED SUTURE TO PERFORM SIMPLE CONTINUOUS SUTURES ON THE VENTRICULAR DEFECT REPAIR SURGERY. AFTER ONE STITCH WAS SEWN, THE NEEDLE BROKE WHEN THE NEEDLE WAS HELD IN THE MIDDLE AND REAR 1/3 POSITION WITH A PEN-TYPE NEEDLE HOLDER ON THE OPERATING TABLE. THE PRODUCT WAS REPLACED AND SEWED AGAIN, SEWED HALFWAY, AND THE NEEDLE BROKE AGAIN WHEN PASSING THROUGH THE TISSUE. REPLACED WITH THE THIRD PRODUCT AND CONTINUED SEWING TO COMPLETE. AFTER THE THIRD SEWING WAS COMPLETED, WHEN TYING THE KNOT, IT WAS FOUND THAT STRIPED APPLIER (WITH RUBBER PROTECTIVE SLEEVE), HOLDING AND CLAMPING SIDE, THE NEEDLE TAIL FELT WAS NOT HELD AND CLAMPED. ALL THREE NEEDLES BROKE AND NOTHING FELL IN PATIENT CAVITY. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18174553 ↗MalfunctionOct 31, 2023Break; Break
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RENAL TRANSPLANTATION, THE NEEDLE SNAPPED WHEN THE SURGEON WAS HANDLING THE SUTURE TO THE NURSE AFTER FINISHING THE SUTURING. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18044173 ↗MalfunctionAug 17, 2023Break; Break
ACCORDING TO THE REPORTER, PRIOR TO USE, THE NEEDLE BROKE VERY EASILY. IT OCCURRED ON FOUR SUTURES WITH DIFFERENT LOT NUMBERS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17561789 ↗MalfunctionAug 17, 2023Break; Break
ACCORDING TO THE REPORTER, PRIOR TO USE, THE NEEDLE BROKE VERY EASILY. IT OCCURRED ON FOUR SUTURES WITH DIFFERENT LOT NUMBERS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17561784 ↗MalfunctionAug 17, 2023Break; Break
ACCORDING TO THE REPORTER, PRIOR TO USE, THE NEEDLE BROKE VERY EASILY. IT OCCURRED ON FOUR SUTURES WITH DIFFERENT LOT NUMBERS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17561774 ↗
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 18, 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