VICRYL RAPIDE VR845Recalls & reported problems
Ethicon, LLC · Undyed Braided (Polyglactin 910), Synthetic Absorbable Suture · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10705031134744), received between May 2, 2019 and May 3, 2019 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Break” (10 reports).
1 FDA recall record name this device's identifier.
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.
Recalls naming this device
- Aug 17, 2017Terminated
On August 17, 2017, Ethicon had decided to initiate a medical device recall (removal) of the twenty-five (25) lots of VICRYL RAPIDETM (Polyglactin 910) Suture that were distributed to the field. During finished goods testing, a suture damage was identified on a lot of VICRYL RAPIDETM Suture. During the course of the subsequent investigation, the suture also failed knot tensile strength testing.
Z-0693-2018 · Root cause: Equipment maintenance · FDA record ↗
Most reported problems
Device problems
- Break10
Patient problems
- No Consequences Or Impact To Patient10
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 3, 2019Break; Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. WHEN THE SURGEON STARTED TO TIE THE KNOT AND WENT TO TIGHTEN IT, THE SUTURE SNAPPED. THE PROCEDURE WAS COMPLETED WITH SUTURE DEVICE FROM A DIFFERENT COMPANY. THERE WERE NO PATIENT CONSEQUENCES REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8578629 ↗MalfunctionMay 3, 2019Break; Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. WHEN THE SURGEON STARTED TO TIE THE KNOT AND WENT TO TIGHTEN IT, THE SUTURE SNAPPED. THE PROCEDURE WAS COMPLETED WITH SUTURE DEVICE FROM A DIFFERENT COMPANY. THERE WERE NO PATIENT CONSEQUENCES REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8578626 ↗MalfunctionMay 3, 2019Break; Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. WHEN THE SURGEON STARTED TO TIE THE KNOT AND WENT TO TIGHTEN IT, THE SUTURE SNAPPED. THE PROCEDURE WAS COMPLETED WITH SUTURE DEVICE FROM A DIFFERENT COMPANY. THERE WERE NO PATIENT CONSEQUENCES REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8578624 ↗MalfunctionMay 3, 2019Break; Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. WHEN THE SURGEON STARTED TO TIE THE KNOT AND WENT TO TIGHTEN IT, THE SUTURE SNAPPED. THE PROCEDURE WAS COMPLETED WITH SUTURE DEVICE FROM A DIFFERENT COMPANY. THERE WERE NO PATIENT CONSEQUENCES REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8578623 ↗MalfunctionMay 3, 2019Break; Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. WHEN THE SURGEON STARTED TO TIE THE KNOT AND WENT TO TIGHTEN IT, THE SUTURE SNAPPED. THE PROCEDURE WAS COMPLETED WITH SUTURE DEVICE FROM A DIFFERENT COMPANY. THERE WERE NO PATIENT CONSEQUENCES REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8578620 ↗MalfunctionMay 3, 2019Break; Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. WHEN THE SURGEON STARTED TO TIE THE KNOT AND WENT TO TIGHTEN IT, THE SUTURE SNAPPED. THE PROCEDURE WAS COMPLETED WITH SUTURE DEVICE FROM A DIFFERENT COMPANY. THERE WERE NO PATIENT CONSEQUENCES REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8578616 ↗MalfunctionMay 3, 2019Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN OBGYN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. WHEN THEY STARTED TO TIE THE KNOT AND THEY WENT TO TIGHTEN IT, IT JUST SNAPPED. THE CASE WAS COMPLETED WITH ANOTHER SUTURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8576407 ↗MalfunctionMay 2, 2019Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN OBGYN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. WHEN THEY STARTED TO TIE THE KNOT AND THEY WENT TO TIGHTEN IT, IT JUST SNAPPED. THE CASE WAS COMPLETED WITH ANOTHER SUTURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8576399 ↗MalfunctionMay 2, 2019Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN OBGYN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. WHEN THEY STARTED TO TIE THE KNOT AND THEY WENT TO TIGHTEN IT, IT JUST SNAPPED. THE CASE WAS COMPLETED WITH ANOTHER SUTURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8576392 ↗MalfunctionMay 2, 2019Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN OBGYN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. WHEN THEY STARTED TO TIE THE KNOT AND THEY WENT TO TIGHTEN IT, IT JUST SNAPPED. THE CASE WAS COMPLETED WITH ANOTHER SUTURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8576380 ↗
Other SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID devices
- Coated VICRYL VCP433HEthicon, LLC · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 death1,093 reports
- Polysorb CL-915Covidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID503 reports
- Coated VICRYL VCP493HEthicon, LLC · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID435 reports
- V-Loc 180 VLOCL0316Covidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall376 reports
- Coated VICRYL VCP345HEthicon, LLC · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 death405 reports
- V-Loc 180 VLOCL0604Covidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall328 reports
- V-Loc 180 VLOCA008LCovidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall294 reports
- V-Loc 180 VLOCL0326Covidien LP · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID330 reports
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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page