VISORB 494ARecalls & reported problems
C.P. Medical Corporation · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10790986000657), received between Jul 2, 2019 and Dec 13, 2019 — classified as 9 malfunctions.
The most frequently reported specific device problem is “Break” (7 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
- Break7
- Nonstandard Device3
- Material Frayed2
- Material Integrity Problem2
- Product Quality Problem1
Patient problems
- No Consequences Or Impact To Patient3
- No Known Impact Or Consequence To Patient3
- Wound Dehiscence3
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 13, 2019Material Frayed; Product Quality Problem
IT WAS REPORTED SIZE 4/0 PGA SUTURE BEING WEAK AND FRAYING UPON USE. (LOT# 190425-51) THERE WAS PATIENT INVOLVEMENT BUT NO INDICATION OF AN ADVERSE EVENT. THE SURGERY WASN'T DELAYED GREATER THAN 30 MINUTES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9470122 ↗MalfunctionDec 11, 2019Break
IT WAS REPORTED SIZE 4/0 PGA SUTURE BREAKING DURING PROCEDURE. (LOT# 190423-53). THERE WAS PATIENT INVOLVEMENT BUT NO INDICATION OF AN ADVERSE EVENT. THE DISTRIBUTOR HAS BEEN CONTACTED SEVERAL TIMES AND HASN'T PROVIDED DETAILS OF EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9454661 ↗MalfunctionOct 21, 2019Break; Nonstandard Device; Material Integrity Problem
IT WAS REPORTED THAT SIZE 4/0 POLYGLYCOLIC ACID SUTURE SNAPPED EASILY AND KNOTS WERE NOT HOLDING. (LOT# 190123-59) THREE PATIENTS SUBSEQUENTLY EXPERIENCED DEHISCENCE OF WOUNDS. THE CLINIC HAS BEEN CONTACTED MULTIPLE TIMES IN ATTEMPT TO RETRIEVE INFORMATION REGARDING EACH PATIENT'S EVENT. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MDR WILL BE SUBMITTED.
Patient problems: Wound Dehiscence
MAUDE report 9214956 ↗MalfunctionOct 21, 2019Break; Nonstandard Device; Material Integrity Problem
IT WAS REPORTED THAT SIZE 4/0 POLYGLYCOLIC ACID SUTURE SNAPPED EASILY AND KNOTS WERE NOT HOLDING. (LOT# 190123-59) THREE PATIENTS SUBSEQUENTLY EXPERIENCED DEHISCENCE OF WOUNDS. THE CLINIC HAS BEEN CONTACTED MULTIPLE TIMES IN ATTEMPT TO RETRIEVE INFORMATION REGARDING EACH PATIENT'S EVENT. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MDR WILL BE SUBMITTED.
Patient problems: Wound Dehiscence
MAUDE report 9214955 ↗MalfunctionOct 21, 2019Break; Nonstandard Device
IT WAS REPORTED THAT SIZE 4/0 POLYGLYCOLIC ACID SUTURE SNAPPED EASILY AND KNOTS WERE NOT HOLDING. (LOT# 190123-59) THREE PATIENTS SUBSEQUENTLY EXPERIENCED DEHISCENCE OF WOUNDS. THE CLINIC HAS BEEN CONTACTED MULTIPLE TIMES IN ATTEMPT TO RETRIEVE INFORMATION REGARDING EACH PATIENT'S EVENT. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MDR WILL BE SUBMITTED.
Patient problems: Wound Dehiscence
MAUDE report 9214952 ↗MalfunctionSep 27, 2019Material Frayed
IT WAS REPORTED SIZE 4/0 POLYGLYCOLIC ACID SUTURE TEARING OR FRAYING. (LOT# 190423-53) THERE WAS PATIENT INVOLVEMENT BUT NO INDICATION OF AN ADVERSE EVENT. THE SURGERY WASN'T DELAYED GREATER THAN 30 MINUTES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9131080 ↗MalfunctionJul 2, 2019Break
IT WAS REPORTED POLYGLYCOLIC ACID SUTURE BREAKING WHILE TYING KNOTS. (LOT# 190123-59) THE DOCTOR HAS BEEN CONTACTED SEVERAL TIMES AND IS UNWILLING TO PROVIDE DETAILS OF THE EVENTS. THERE IS NO INDICATION OF THE PATIENT EXPERIENCING AN ADVERSE EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8755889 ↗MalfunctionJul 2, 2019Break
IT WAS REPORTED POLYGLYCOLIC ACID SUTURE BREAKING WHILE TYING KNOTS. (LOT# 181205-68) THE DOCTOR HAS BEEN CONTACTED SEVERAL TIMES AND IS UNWILLING TO PROVIDE DETAILS OF THE EVENTS. THERE IS NO INDICATION OF THE PATIENT EXPERIENCING AN ADVERSE EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8755888 ↗MalfunctionJul 2, 2019Break
IT WAS REPORTED POLYGLYCOLIC ACID SUTURE BREAKING WHILE TYING KNOTS. (LOT# 180720-51) THE DOCTOR HAS BEEN CONTACTED SEVERAL TIMES AND IS UNWILLING TO PROVIDE DETAILS OF THE EVENTS. THERE IS NO INDICATION OF THE PATIENT EXPERIENCING AN ADVERSE EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8755887 ↗
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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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