Surgipro ll VP-701-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
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521038127), received between Sep 11, 2017 and Jan 6, 2023 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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.
Most reported problems
Device problems
- Detachment of Device or Device Component2
- Break1
- Manufacturing, Packaging or Shipping Problem1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
- No Patient Involvement1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 6, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, INTRAOPERATIVELY, DURING ANASTOMOSIS, THE NEEDLE BROKE OFF THE SUTURE MULTIPLE TIMES FROM SUTURES OUT OF THE SAME BOX..
Patient problems: Insufficient Information
MAUDE report 16118187 ↗MalfunctionJul 19, 2021Break; Break
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A CARDIAC SURGERY, USING THE CONTINUOUS SUTURING TECHNIQUE, THE NEEDLE BROKE WHEN IT WAS CLAMPED WITH A NEEDLE HOLDER. ANOTHER DEVICE FROM THE SAME LOT WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12188884 ↗MalfunctionOct 15, 2018Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
ACCORDING TO THE REPORTER, WHILE PULLING THE SUTURE PRE OPERATIVELY, THEY NOTICED THAT THERE WAS ONLY ONE NEEDLE ATTACHED TO THE STRAND ON A SUTURE THAT WAS SUPPOSED TO BE DOUBLE ARMED. THEY USED NEW SUTURE TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 7964990 ↗MalfunctionSep 11, 2017Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER: OCCURRED DURING THE PROCEDURE, BUT THE PRODUCT WAS NOT USED ON THE PATIENT. WHEN THE NEEDLE WAS REMOVED FROM THE PACKAGING, THE NEEDLE DETACHED FROM THE THREAD. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY OR EXTENSION IN SURGICAL TIME. PATIENT STATUS IS NO PROBLEM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6855792 ↗
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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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