PRONOVA 3557HRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10705031004504), received between Jul 31, 2019 and Jan 18, 2022 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (6 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

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 18, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN TRYING TO TIE THE SUTURE AFTER PLACING THE FIRST STITCH, IT WAS NOTED THAT ONE SIDE OF THE NEEDLE WAS MISSING. IT WAS SEARCHED DURING THE SURGERY, BUT IT COULD NOT BE FOUND. SO, THE SURGEON JUDGED THAT THE NEEDLE HAD BEEN DETACHED FROM THE SUTURE ORIGINALLY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13282575 ↗
• MalfunctionDec 22, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. THE SUTURE BROKE DURING USE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13060394 ↗
• MalfunctionNov 5, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AORTIC ARCH REPAIR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING ROUTINE USE, THE SUTURE DESWAGED AND CAME OFF IN THE MIDDLE OF RUNNING A SUTURE LINE DURING AORTIC ARCH REPLACEMENT. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9281616 ↗
• MalfunctionAug 2, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR SURGERY ON (B)(6) 2019 AND SUTURE WAS USED. THE SUTURE WAS BROKEN OTHER THAN KNOT DURING USE. IT WAS COMMENTED THAT THE SUTURE DID NOT COME IN CONTACT WITH SHARP THING. ANOTHER LOT PRODUCT WAS USED WITH NO PROBLEM. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8858160 ↗
• MalfunctionAug 2, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR SURGERY ON (B)(6) 2019 AND SUTURE WAS USED. THE SUTURE WAS BROKEN OTHER THAN KNOT DURING USE. IT WAS COMMENTED THAT THE SUTURE DID NOT COME IN CONTACT WITH SHARP THING. ANOTHER LOT PRODUCT WAS USED WITH NO PROBLEM. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8858155 ↗
• MalfunctionAug 2, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR SURGERY ON (B)(6) 2019 AND SUTURE WAS USED. THE SUTURE WAS BROKEN OTHER THAN KNOT DURING USE. IT WAS COMMENTED THAT THE SUTURE DID NOT COME IN CONTACT WITH SHARP THING. ANOTHER LOT PRODUCT WAS USED WITH NO PROBLEM. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8858109 ↗
• MalfunctionAug 2, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR SURGERY ON (B)(6) 2019 AND SUTURE WAS USED. THE SUTURE WAS BROKEN OTHER THAN KNOT DURING USE. IT WAS COMMENTED THAT THE SUTURE DID NOT COME IN CONTACT WITH SHARP THING. ANOTHER LOT PRODUCT WAS USED WITH NO PROBLEM. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8858088 ↗
• MalfunctionAug 2, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR SURGERY ON (B)(6) 2019 AND SUTURE WAS USED. THE SUTURE WAS BROKEN OTHER THAN KNOT DURING USE. IT WAS COMMENTED THAT THE SUTURE DID NOT COME IN CONTACT WITH SHARP THING. ANOTHER LOT PRODUCT WAS USED WITH NO PROBLEM. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8856539 ↗
• MalfunctionJul 31, 2019Material Separation; Material Separation

  THIS REPORT SUMMARIZES <NOE> 2 </NOE> MALFUNCTION EVENTS, INCLUDING 0 INITIAL EVENTS. IT SUMMARIZES FOLLOW UP MALFUNCTION EVENTS, INCLUDING 0 SUTURE BREAKAGE, 0 NEEDLE BREAKAGE AND 2 NEEDLE PULL-OFF THAT OCCURRED INTRAOPERATIVELY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8847631 ↗