Surgipro ll SP-5698GRecalls & 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
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521037007), received between Apr 8, 2020 and May 15, 2024 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Break2
- Patient-Device Incompatibility2
- Adverse Event Without Identified Device or Use Problem1
- Detachment of Device or Device Component1
- Insufficient Device Problem Information1
Patient problems
- Insufficient Information2
- No Clinical Signs, Symptoms or Conditions2
- Foreign Body Reaction1
- No Consequences Or Impact To Patient1
- Skin Inflammation/ Irritation1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE VETERINARIAN USED THE SUTURE ON THREE DIFFERENT PATIENTS AND ALL HAD A REACTION.
Patient problems: Insufficient Information
MAUDE report 19323975 ↗MalfunctionMay 15, 2024Patient-Device Incompatibility; Patient-Device Incompatibility
ACCORDING TO THE REPORTER, 10-14 DAYS POSTOPERATIVE OF A VETERINARY PROCEDURE, THE PATIENT RETURNED FOR SUTURE REMOVAL WITH SKIN IRRITATION TO THE SUTURE. WHEN THE SUTURE WAS REMOVED, THE SKIN CLEARED UP.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 19323438 ↗MalfunctionMay 15, 2024Patient-Device Incompatibility; Patient-Device Incompatibility
ACCORDING TO THE REPORTER, POST-OPERATIVE A VETERINARY PROCEDURE, THE PATIENT RETURNED FOR SUTURE REMOVAL WITH SKIN IRRITATION TO THE SUTURE. THE PATIENT HAD DRAINING TRACT WHICH CLEARED UP ONCE THE SUTURE WAS REMOVED.
Patient problems: Foreign Body Reaction
MAUDE report 19322885 ↗MalfunctionApr 23, 2024Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information
ACCORDING TO THE REPORTER, PREOPERATIVELY, WHEN IT WAS ATTEMPTED TO BE USED AFTER OPENING THE PRODUCT, IT WAS OBSERVED THAT THE TIP OF THE NEEDLE WAS CHIPPED. THE SUTURE WAS CHANGED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 19163704 ↗MalfunctionApr 16, 2024Break; Break
ACCORDING TO THE REPORTER, PREOPERATIVELY, WHEN IT WAS ATTEMPTED TO BE USED AFTER OPENING THE PRODUCT, IT WAS OBSERVED THAT THE TIP OF THE NEEDLE WAS CHIPPED. THE SUTURE WAS CHANGED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19117806 ↗MalfunctionApr 8, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE AND THREAD HAD BEEN FOUND DETACHED FROM THE BEGINNING. A NEW PACKAGE WAS TAKEN OUT AND USED TO COMPLETE THE CASE. THE EVENT OCCURRED DURING THE PROCEDURE BUT THE PRODUCT WAS NOT USED FOR PATIENT. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9937067 ↗
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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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