VICRYL RAPIDERecalls & reported problems across all models
Ethicon, LLC · 18 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 397
- Deaths reported
- 0
- Injuries reported
- 60
- Recalls
- 1
We found 18 models of VICRYL RAPIDE by Ethicon, LLC in the FDA's device registry (GUDID). Together they are named in 397 adverse event reports in the FDA's MAUDE database, received between Dec 18, 2017 and Sep 30, 2026 — classified as 60 injuries, 337 malfunctions.
The most frequently reported specific device problem is “Break” (222 reports).
1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
VICRYL RAPIDE recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- 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 · names 6 of these models · Recall details · FDA record ↗
Most reported VICRYL RAPIDE problems
Device problems
- Break222
- Material Separation109
- Material Integrity Problem34
- Adverse Event Without Identified Device or Use Problem30
- Dull, Blunt11
- Defective Component5
- Component Misassembled4
- Device Markings/Labelling Problem4
Patient problems
- No Clinical Signs, Symptoms or Conditions239
- No Consequences Or Impact To Patient66
- Wound Dehiscence37
- Pain24
- Impaired Healing22
- Inflammation16
- Purulent Discharge13
- Post Operative Wound Infection10
VICRYL RAPIDE models
18 models, most reported first. Each model has its own page with its reports, recalls and device details.
- VICRYL RAPIDE VR917SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall117 reports
- VICRYL RAPIDE VR945SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall42 reports
- VICRYL RAPIDE VR494SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall34 reports
- VICRYL RAPIDE VR496SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall11 reports
- VICRYL RAPIDE VR845SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall10 reports
- VICRYL RAPIDE VR426SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall7 reports
- VICRYL RAPIDE VR944SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID47 reports
- VICRYL RAPIDE VR935SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID33 reports
- VICRYL RAPIDE VR493SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID27 reports
- VICRYL RAPIDE VR214SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID18 reports
- VICRYL RAPIDE VR416SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID15 reports
- VICRYL RAPIDE VR916SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID9 reports
- VICRYL RAPIDE VR931SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID8 reports
- VICRYL RAPIDE VR490SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID7 reports
- VICRYL RAPIDE VR417SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID5 reports
- VICRYL RAPIDE VR497SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID3 reports
- VICRYL RAPIDE VR844SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID3 reports
- VICRYL RAPIDE VR835SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 report
Recent VICRYL RAPIDE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951358 ↗MalfunctionSep 30, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951344 ↗MalfunctionSep 30, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951343 ↗MalfunctionSep 30, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951340 ↗MalfunctionSep 30, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951336 ↗MalfunctionSep 30, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951335 ↗MalfunctionSep 30, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951332 ↗MalfunctionSep 30, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951326 ↗MalfunctionSep 30, 2026Material Separation
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used. During the procedure, the problem of pulling off suture needle happened. The needle did not fell into the patient. Changed to another one to complete the surgery. There were no adverse patent consequences reported. Additional information was requested.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949320 ↗MalfunctionSep 30, 2026Material Separation
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used. During the procedure, the problem of pulling off suture needle happened. The needle did not fell into the patient. Changed to another one to complete the surgery. There were no adverse patent consequences reported. Additional information was requested.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949310 ↗MalfunctionSep 21, 2026Material Separation
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used. It was reported to the sales rep that during an unknown procedure, the needle repeatedly detached from the suture material during use. No patient consequences. Device is not available for return. Additional information was requested.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50840849 ↗MalfunctionSep 21, 2026Material Separation
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used. It was reported to the sales rep that during an unknown procedure, the needle repeatedly detached from the suture material during use. No patient consequences. Device is not available for return. Additional information was requested.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50840844 ↗MalfunctionAug 24, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50419127 ↗InjuryAug 19, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a patient gave birth to a full-term baby through vaginal delivery on (b)(6)2026. The amniotic fluid was clear and the perineum had a degree I laceration. The doctor first sutured the subcutaneous tissue with sutures, and then performed intradermal suturing of the skin with suture . After the suturing was completed, the wound was checked to be well aligned and there was no bleeding. On the third day after surgery, the patient underwent examination and found suspicious exposed suture in the perineum wound. The wound was slightly red and swollen (inflammation), without tearing, and the doctor strengthened local dressing treatment. On the 5th day after the patient's surgery, the perineal wound was slightly red and swollen, with some sutures exposed. The epidermal layer of the wound was cracked by about 3mm and there was exudate. The doctor performed local cleaning and disinfection, removed the exposed sutures, and changed the dressing. Additional information was requested.
Patient problems: Erythema; Fluid Discharge; Inflammation; Pocket Erosion; Swelling/ Edema; Wound Dehiscence
MAUDE report 50329145 ↗InjuryAug 6, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used. The patient experienced a wound dehiscence recently after using the suture. Additional information was requested.
Patient problems: Wound Dehiscence
MAUDE report 50167348 ↗
Other Ethicon, LLC products
- Coated VICRYL350 models · 8,555 reports · 1 recall
- STRATAFIX181 models · 7,673 reports · 7 recalls
- PROLENE358 models · 7,292 reports · 2 recalls
- PDS224 models · 2,635 reports · 10 recalls
- MONOCRYL127 models · 2,308 reports · 3 recalls
- ETHILON133 models · 1,680 reports · 1 recall
- DERMABOND PRINEO4 models · 1,099 reports
- ETHIBOND EXCEL134 models · 921 reports · 2 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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