Surgipro ll VP-975-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
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884521039735), received between Jun 29, 2018 and Jan 12, 2024 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Break” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break7
Patient problems
- Insufficient Information4
- No Clinical Signs, Symptoms or Conditions4
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 12, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A AORTIC VALVE REPLACEMENT AND ASCENDING ROOT REPLACEMENT, EVERY TIME THE SURGEON PULLED THE SUTURE, THE NEEDLE WOULD SNAP AND IT IS TO TAKE IT OFF THE PACKET. THEY REMOVED THE WHOLE BOX IN CIRCULATION AND OPENED ANOTHER AND IT WAS FINE. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18505341 ↗MalfunctionJan 12, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A AORTIC VALVE REPLACEMENT AND ASCENDING ROOT REPLACEMENT, EVERY TIME THE SURGEON PULLED THE SUTURE, THE NEEDLE WOULD SNAP AND IT IS TO TAKE IT OFF THE PACKET. THEY REMOVED THE WHOLE BOX IN CIRCULATION AND OPENED ANOTHER AND IT WAS FINE. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18503819 ↗MalfunctionNov 16, 2023Break; Break
ACCORDING TO THE REPORTER, ON A PROCEDURE, THE THREADS OF THE TWO DEVICES WERE BROKEN.
Patient problems: Insufficient Information
MAUDE report 18156903 ↗MalfunctionNov 16, 2023Break; Break
ACCORDING TO THE REPORTER, DURING MITRAL VALVE SURGERY, CLOSURE OF THE LEFT ATRIUM, UPON TYING A KNOT, THE THREAD OF THE TWO SUTURES WAS BROKEN. THE SURGEON STARTED THE OPERATION AGAIN TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18156893 ↗MalfunctionMar 30, 2021Break; Break
ACCORDING TO THE REPORTER, ON AN OPEN ANEURYSM PROCEDURE, THE SUTURE BROKE. NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11593462 ↗MalfunctionApr 3, 2020Break; Break
ACCORDING TO THE REPORTER, WHILE SUTURING THE VESSEL DURING AN OPEN VASCULAR SURGERY, THE THREADS OF TEN SUTURES BROKE. A NEW PACKAGE WAS OPENED AND USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9924707 ↗MalfunctionJun 29, 2018Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SUTURE BROKE AT ITS CENTRAL PART. ANOTHER SUTURE WAS USED AND THE SAME EVENT OCCURRED ON 4 SUTURES. THERE WAS NO PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7650829 ↗
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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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