PRONOVARecalls & reported problems across all models
Ethicon, LLC · 27 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 101
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 0
We found 27 models of PRONOVA by Ethicon, LLC in the FDA's device registry (GUDID). Together they are named in 101 adverse event reports in the FDA's MAUDE database, received between Jul 18, 2018 and May 13, 2026 — classified as 1 injury, 100 malfunctions.
The most frequently reported specific device problem is “Break” (58 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. 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
Most reported PRONOVA problems
Device problems
- Break58
- Material Separation43
- Device Contaminated During Manufacture or Shipping5
- Material Integrity Problem2
- Tear, Rip or Hole in Device Packaging2
Patient problems
- No Consequences Or Impact To Patient52
- No Clinical Signs, Symptoms or Conditions48
- Not Applicable1
- Paralysis1
- Shock1
PRONOVA models
27 models, most reported first. Each model has its own page with its reports, recalls and device details.
- PRONOVA 3556HSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE13 reports
- PRONOVA PN3557HSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE11 reports
- PRONOVA D10114SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE10 reports
- PRONOVA 3557HSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE9 reports
- PRONOVA 3702HSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE8 reports
- PRONOVA PN3741LGSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE8 reports
- PRONOVA M3767SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE5 reports
- PRONOVA PN3735HSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE5 reports
- PRONOVA M3709SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE4 reports
- PRONOVA PN3556HSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE4 reports
- PRONOVA 3706HSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE3 reports
- PRONOVA 3776HSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE3 reports
- PRONOVA 3725HSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE2 reports
- PRONOVA M3735SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE2 reports
- PRONOVA PN3720HSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE2 reports
- PRONOVA 3521HSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 report
- PRONOVA 3522HSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 report
- PRONOVA 3709HSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 report
- PRONOVA 3720HSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 report
- PRONOVA 3976HSUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 report
- PRONOVA M3702SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 report
- PRONOVA M3703SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 report
- PRONOVA M3737SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 report
- PRONOVA M3739SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 report
- PRONOVA M3805SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 report
- PRONOVA PNM3709SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 report
- PRONOVA PNM3805SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 report
Recent PRONOVA adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 13, 2026Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN SURGERY, IT WAS FOUND THAT THERE WAS A FOREIGN MATTER IN EACH PACKAGE WHEN THE PACKAGE WAS OPENED AFTER THE PRODUCT WAS DELIVERED TO THE HOSPITAL. IT WAS NOT A CONTROL RELEASE NEEDLE. THIS EVENT WAS FOUND BEFORE USE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. WHEN WE SEND THE SAMPLE TO YOU, WE WILL LET YOU KNOW ITS RETURN DATE AND TRACKING NUMBER. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25164765 ↗MalfunctionApr 22, 2026Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026, AND SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24953453 ↗MalfunctionApr 22, 2026Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026, AND SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24953452 ↗MalfunctionApr 22, 2026Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026, AND SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24953440 ↗MalfunctionApr 6, 2026Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 SUTURE WAS USED. DURING SURGERY, IT WAS FOUND THAT THERE WAS DIRT ON THE NEEDLE. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24793921 ↗MalfunctionDec 31, 2025Break; Material Integrity Problem; Break; Material Integrity Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE DEVICES BROKE EASILY. THEY ARE FRAGILE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23935422 ↗MalfunctionDec 30, 2025Break; Material Integrity Problem; Break; Material Integrity Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE DEVICES BROKE EASILY. THEY ARE FRAGILE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23926212 ↗MalfunctionDec 30, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE FINAL TYING OF AN UNKNOWN CARDIOVASCULAR SURGERY, THE SUTURE IN THE MIDDLE WAS BROKEN DURING USE, NOT AT THE KNOT PART. SINCE THE SAME ISSUE OCCURRED SEVERAL TIMES, THE DOCTOR REQUESTED AN INVESTIGATION TO SEE IF THE SAME ISSUE OCCURRED IN OTHER PRODUCTS FROM THE SAME LOT. BOTH PN3556H AND D10114 ARE NOT A CONTROL RELEASE NEEDLE. ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. LOT NUMBER ¿ 106130 FOR PN3556H, AND 10795H FOR D10114 - UNKNOWN IF THESE ARE THE CORRECT LOT NUMBER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23924682 ↗MalfunctionDec 30, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE FINAL TYING OF AN UNKNOWN CARDIOVASCULAR SURGERY, THE SUTURE IN THE MIDDLE WAS BROKEN DURING USE, NOT AT THE KNOT PART. SINCE THE SAME ISSUE OCCURRED SEVERAL TIMES, THE DOCTOR REQUESTED AN INVESTIGATION TO SEE IF THE SAME ISSUE OCCURRED IN OTHER PRODUCTS FROM THE SAME LOT. BOTH PN3556H AND D10114 ARE NOT A CONTROL RELEASE NEEDLE. ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. LOT NUMBER ¿ 106130 FOR PN3556H, AND 10795H FOR D10114 - UNKNOWN IF THESE ARE THE CORRECT LOT NUMBER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23924674 ↗MalfunctionDec 30, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE FINAL TYING OF AN UNKNOWN CARDIOVASCULAR SURGERY, THE SUTURE IN THE MIDDLE WAS BROKEN DURING USE, NOT AT THE KNOT PART. SINCE THE SAME ISSUE OCCURRED SEVERAL TIMES, THE DOCTOR REQUESTED AN INVESTIGATION TO SEE IF THE SAME ISSUE OCCURRED IN OTHER PRODUCTS FROM THE SAME LOT. BOTH PN3556H AND D10114 ARE NOT A CONTROL RELEASE NEEDLE. ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. LOT NUMBER ¿ 106130 FOR PN3556H, AND 10795H FOR D10114 - UNKNOWN IF THESE ARE THE CORRECT LOT NUMBER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23924666 ↗MalfunctionDec 30, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE FINAL TYING OF AN UNKNOWN CARDIOVASCULAR SURGERY, THE SUTURE IN THE MIDDLE WAS BROKEN DURING USE, NOT AT THE KNOT PART. SINCE THE SAME ISSUE OCCURRED SEVERAL TIMES, THE DOCTOR REQUESTED AN INVESTIGATION TO SEE IF THE SAME ISSUE OCCURRED IN OTHER PRODUCTS FROM THE SAME LOT. BOTH PN3556H AND D10114 ARE NOT A CONTROL RELEASE NEEDLE. ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. LOT NUMBER ¿ 106130 FOR PN3556H, AND 10795H FOR D10114 - UNKNOWN IF THESE ARE THE CORRECT LOT NUMBER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23924662 ↗MalfunctionDec 5, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC KIDNEY TRANSPLANT PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING A ROBOTIC KIDNEY TRANSPLANT PROCEDURE, THE SALES REPRESENTATIVE REPORTED THAT THE SUTURE WAS USED TO ANASTOMOSE THE RENAL VEIN. MIDWAY THROUGH THE ANASTOMOSIS, THE SUTURE BROKE. THERE WERE NO REPORTED PATIENT CONSEQUENCES. THE DEVICE IS NOT AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23729961 ↗MalfunctionSep 12, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING SURGERY, THE SUTURE WAS BROKEN. IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23037154 ↗MalfunctionApr 25, 2025Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN VASCULAR PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21908550 ↗MalfunctionMar 27, 2025Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG ON (B)(6) 2025 AND SUTURE WAS USED. THE NEEDLE POPPED OFF THE SUTURE DURING ANASTOMOSIS. CASE WAS COMPLETED WITH A LIKE DEVICE. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21712974 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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