Syneture US1696Recalls & reported problems
Covidien LP · Custom Suture Pack, (2) 88862589-63, (2) 88863324-56, (4) GS-832, (2) VLOCM0024, (2) VP-521-X, (1) VP-522-X, (2) VP-557-X, (8) VP-761-X · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521581173), received between Apr 25, 2018 and Apr 25, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Break1
- Detachment Of Device Component1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 25, 2018Break; Detachment Of Device Component; Break; Detachment Of Device Component
ACCORDING TO THE REPORTER, DURING AN OPEN HEART PROCEDURE, THE THREAD BROKE AND FELL INTO THE CAVITY AND WAS RETRIEVED. AS REPORTED, THERE WAS NO PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7459170 ↗
Other Suture kit devices
- LSL HEALTHCARE 7554LSL Industries, LLC · Suture kit1 recall0 reports
- Medline Industries, Inc. P903933BMedline Industries, Inc. · Suture kit1 recall0 reports
- Lock-Stitch™ Procedure Kit CM9500Cayenne Medical, Inc. · Suture Kit2 reports
- McKesson 25-2748Mckesson Medical-Surgical Inc. · Suture Kit2 reports
- Medical Action Industries 79350Medical Action Industries Inc. · Suture kit1 report
- MaxBraid Suture BroadBand Tape (Basic) 110046602Riverpoint Medical, LLC · Suture Kit1 report
- Syneture US1716Covidien LP · Suture kit1 report
- Syneture US1560Covidien LP · Suture kit1 report
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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