PRONOVA 3556HRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10705031004498), received between Apr 17, 2019 and Feb 27, 2020 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 16, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 27, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. THE SUTURE WAS BROKEN DURING CONTINUOUS SUTURING. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9765799 ↗
• MalfunctionFeb 27, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. THE SUTURE WAS BROKEN DURING CONTINUOUS SUTURING. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9765762 ↗
• MalfunctionFeb 27, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR PROCEDURE ON (B)(6) 2020 AND SUTURE WAS USED. THE SUTURE WAS BROKEN DURING CONTINUOUS SUTURING. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9765728 ↗
• MalfunctionJan 13, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR SURGERY ON (B)(6) 2019 AND SUTURE WAS USED. THE SUTURE BREAKAGE OCCURRED AT THE SWAGE PART DURING CONTINUOUS SUTURING. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9582747 ↗
• MalfunctionJan 13, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR SURGERY ON (B)(6) 2019 AND SUTURE WAS USED. THE SUTURE BREAKAGE OCCURRED AT THE SWAGE PART DURING CONTINUOUS SUTURING. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9582716 ↗
• MalfunctionJan 13, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR SURGERY ON (B)(6) 2019 AND SUTURE WAS USED. THE SUTURE BREAKAGE OCCURRED AT THE SWAGE PART DURING CONTINUOUS SUTURING. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9582706 ↗
• MalfunctionJan 6, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AORTIC VALVE REPLACEMENT SURGERY ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE DURING CONTINUOUS SUTURING. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9554295 ↗
• MalfunctionJan 6, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AORTIC VALVE REPLACEMENT SURGERY ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE DURING CONTINUOUS SUTURING. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9554276 ↗
• MalfunctionJan 6, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AORTIC VALVE REPLACEMENT SURGERY ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE DURING CONTINUOUS SUTURING. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9554210 ↗
• MalfunctionDec 22, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. DURING CONTINUOUS SUTURING, THE SUTURE WAS DETACHED FROM THE NEEDLE. THE NEEDLE WAS NOT CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9508864 ↗
• MalfunctionDec 22, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. DURING CONTINUOUS SUTURING, THE SUTURE WAS DETACHED FROM THE NEEDLE. THE NEEDLE WAS NOT CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9508860 ↗
• MalfunctionDec 22, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. DURING CONTINUOUS SUTURING, THE SUTURE WAS DETACHED FROM THE NEEDLE. THE NEEDLE WAS NOT CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9508852 ↗
• MalfunctionApr 17, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TRICUSPID VALVULOPLASTY ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, ONE NEEDLE OF THE DOUBLE-ARMED SUTURE WAS DETACHED FROM THE SUTURE DURING CONTINUOUS SUTURING ON THE VALVE. THE DROPPED NEEDLE WAS FOUND IN THE THORACIC CAVITY. AFTER THAT, THE OTHER SIDE OF THE NEEDLE WAS DETACHED FROM THE SUTURE DURING SUTURING. THE NEEDLE WAS REMOVED BY VISUAL INSPECTION DURING THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8523337 ↗