Surgipro II VP-541XRecalls & 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
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521037847), received between Nov 30, 2017 and Nov 6, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (2 reports).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Dec 2, 2022Class IIOpen, Classified
Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact
Z-1180-2023 · Root cause: Packaging process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Break2
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 6, 2025Break; Break
ACCORDING TO THE REPORTER, DURING AN AORTO-BI-ILIAC BYPASS, THE TWO SUTURES THREAD BROKE. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23485950 ↗MalfunctionJan 16, 2019Break; Break
ACCORDING TO THE REPORTER, WHEN THE DEVICE WAS USED TO SUTURE THE ATRIUM OF THE HEART IN A TRANSPLANTATION PROCEDURE, THE THREAD AND THE NEEDLE BROKE. THEY CHANGED SUTURE AND SUTURED AGAIN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8255395 ↗MalfunctionNov 30, 2017Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, ONE SIDE OF THE NEEDLE HAD COME OFF THE THREAD. NO INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7073719 ↗
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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 · each recall links to the FDA recall notice
- 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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