PROLENE D7768Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10705031028357), received between Dec 22, 2017 and Dec 28, 2023 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Break” (11 reports).

21 other recalls cover devices cleared under the same FDA submission (K133356); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 28, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE SUTURE WAS BROKEN EASILY DURING USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18410473 ↗
• MalfunctionOct 2, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2023 AND THE SUTURE WAS USED. IT WAS REPORTED THERE WAS A FOREIGN MATTER LIKE A HUMAN HAIR IN THE STERILE PACKAGE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17852451 ↗
• MalfunctionAug 31, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE TYING, THE SUTURE BROKE TWICE IN THE HALFWAY POSITION. 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 17667066 ↗
• MalfunctionAug 31, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE TYING, THE SUTURE BROKE TWICE IN THE HALFWAY POSITION. 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 17667063 ↗
• MalfunctionJan 6, 2023Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT A MVP: MITRAL VALVULOPLASTY ON (B)(6) 2022 AND SUTURE WAS USED. THE NEEDLE WAS LOST DURING USE. THE SURGEON COMMENTED THAT THE NEEDLE MIGHT HAVE COME OUT DURING LIGATION OF RIGHT ATRIAL ATRESIA. THE SUTURE METHOD WAS CONTINUOUS SUTURE. AS A RESULT, THE SURGEON FOUND THE NEEDLE IN THE BODY WITH FLUOROSCOPY DURING THE SAME SURGERY. FURTHER DETAILS ARE NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16112041 ↗
• MalfunctionNov 17, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TRASVERSUS ABDOMINIS MUSCLE RELEASE PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. THE SUTURE BROKE EASILY AROUND THE NEEDLE SWAGE PART, WHEN THE SURGEON TRIED TO TIE THE SUTURE. THIS HAPPENED TWO TIMES. ANOTHER LOT PRODUCT WAS USED FOR THE SURGERY. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15820528 ↗
• MalfunctionNov 17, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TRASVERSUS ABDOMINIS MUSCLE RELEASE PROCEDURE ON (B)(6) /2022 AND SUTURE WAS USED. THE SUTURE BROKE EASILY AROUND THE NEEDLE SWAGE PART, WHEN THE SURGEON TRIED TO TIE THE SUTURE. THIS HAPPENED TWO TIMES. ANOTHER LOT PRODUCT WAS USED FOR THE SURGERY. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15820283 ↗
• MalfunctionJun 29, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHEN PULLING ON THE NEEDLE DURING USE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10209445 ↗
• MalfunctionMar 3, 2020Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN AORTIC VALVE REPLACEMENT AND CORONARY ARTERY BYPASS GRAFT SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING CLOSING OF THE AORTA, THE SUTURE WAS BROKEN WHEN TYING A KNOT. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9780410 ↗
• MalfunctionJan 17, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT ABDOMINAL AORTIC ANEURYSM SURGERY ON (B)(6) 2019 AND SUTURE WAS USED. DURING AN ABDOMINAL AORTIC ANASTOMOSIS, SUTURE WAS BROKEN. THE SURGEON STOPPED USING THE PRODUCT AND USED COMPETITOR¿S PRODUCT. THE SURGEON COMMENTED THAT, DURING ANASTOMOSIS AT THE CENTRAL SIDE OF THE ABDOMINAL AORTA, SUTURE BREAKAGE WAS NEAR THE ROOT OF THE RENAL ARTERY. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. FURTHER DETAILS WERE NOT PROVIDED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9601507 ↗
• MalfunctionJan 17, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT ABDOMINAL AORTIC ANEURYSM SURGERY ON (B)(6) 2019 AND SUTURE WAS USED. DURING AN ABDOMINAL AORTIC ANASTOMOSIS, SUTURE WAS BROKEN. THE SURGEON STOPPED USING THE PRODUCT AND USED COMPETITOR¿S PRODUCT. THE SURGEON COMMENTED THAT, DURING ANASTOMOSIS AT THE CENTRAL SIDE OF THE ABDOMINAL AORTA, SUTURE BREAKAGE WAS NEAR THE ROOT OF THE RENAL ARTERY. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. FURTHER DETAILS WERE NOT PROVIDED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9601487 ↗
• MalfunctionJan 17, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT ABDOMINAL AORTIC ANEURYSM SURGERY ON (B)(6) 2019 AND SUTURE WAS USED. DURING AN ABDOMINAL AORTIC ANASTOMOSIS, SUTURE WAS BROKEN. THE SURGEON STOPPED USING THE PRODUCT AND USED COMPETITOR¿S PRODUCT. THE SURGEON COMMENTED THAT, DURING ANASTOMOSIS AT THE CENTRAL SIDE OF THE ABDOMINAL AORTA, SUTURE BREAKAGE WAS NEAR THE ROOT OF THE RENAL ARTERY. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. FURTHER DETAILS WERE NOT PROVIDED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9601482 ↗
• MalfunctionJan 17, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT ABDOMINAL AORTIC ANEURYSM SURGERY ON (B)(6) 2019 AND SUTURE WAS USED. DURING AN ABDOMINAL AORTIC ANASTOMOSIS, SUTURE WAS BROKEN. THE SURGEON STOPPED USING THE PRODUCT AND USED COMPETITOR¿S PRODUCT. THE SURGEON COMMENTED THAT, DURING ANASTOMOSIS AT THE CENTRAL SIDE OF THE ABDOMINAL AORTA, SUTURE BREAKAGE WAS NEAR THE ROOT OF THE RENAL ARTERY. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. FURTHER DETAILS WERE NOT PROVIDED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9601481 ↗
• MalfunctionAug 14, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, PRIOR TO USE ON THE PATIENT, IT WAS FOUND THAT THE SUTURE HAD BEEN THIN AND TORN-LIKE STATE BEFORE USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8893104 ↗
• MalfunctionJul 9, 2018Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED DURING AN UNKNOWN CARDIOVASCULAR SURGERY ON (B)(6) 2018 A SUTURE WAS PREPARED FOR USE IN THE OPERATING ROOM. THE NEEDLE-SUTURE IN QUESTION WAS NOT USED ON THE PATIENT. THE SURGEON REQUESTED MANUFACTURER INVESTIGATE IF THERE IS A PIN HOLE ON THE PACKAGE OF THE NEEDLE SUTURE THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7671052 ↗
• MalfunctionApr 25, 2018Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT DURING UNKNOWN PROCEDURE SUTURE WAS USED ON (B)(6) 2018. THE PACKAGE HAD THE INNER PAPER PACKAGE CAUGHT AT THE SEALED AREA OF THE OUTER PACKAGE. PART OF THE INNER PACKAGE HAD PROTRUDED TO THE OUTER PACKAGE. WHEN TRYING TO OPEN THE OUTER PACKAGE, THE INNER PACKAGE WAS TORN BECAUSE A THE INNER PACKAGE ADHERED TO THE SEALED AREA OF THE OUTER PACKAGE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7462639 ↗
• MalfunctionMar 7, 2018Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT A SCRUB NURSE ASSISTED IN A CARDIOVASCULAR PROCEDURE ON (B)(6) 2018 AND SUTURE WAS USED ON THE PATIENT. DURING THE PROCEDURE, THE SCRUB NURSE PRICKED HIS/HER FINGER ON THE NEEDLE WHEN TRYING TO TAKE OUT THE NEEDLE FROM THE PACKAGE. THIS EVENT OCCURRED BECAUSE THE NEEDLE HAD PROTRUDED FROM THE PACKAGE BEFORE OPENING THE PACKAGE. THE INJURY WAS SLIGHT. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REQUIRED FOR THE NURSE AND IT WAS REPORTED AS THE NURSE HAVING NO CURRENT PROBLEMS. THERE WERE NO ADVERSE CONSEQUENCES FOR THE NURSE OR THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7320453 ↗
• MalfunctionDec 22, 2017Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR SURGERY, AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS FOUND THAT THE SUTURE HAD COME OFF THE SPONGE, AND HAD BEEN EXPOSED OUTSIDE THE PAPER FOLDER BEFORE OPENING THE PACKAGE. THE NEEDLE HAD NOT PENETRATED THE PAPER FOLDER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7141434 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K133356. One submission often covers many models, so check the product and lot details in each record.

• Z-1515-2025 · Mar 7, 2025 · Open, Classified
  PROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM
• Z-1096-2025 · Dec 20, 2024 · Open, Classified
  PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is indicated for use in general soft tissue approximation and/or ligation, including use in ca
• Z-2452-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748
• Z-2458-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
• Z-2457-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688
• Z-2465-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027
• Z-2461-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746
• Z-2462-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844
• Z-2451-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416
• Z-2460-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662
• Z-2449-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981
• Z-2466-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE 122CM M1.5, D10189
• Z-2464-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
• Z-2448-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031
• Z-2453-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768

…and 6 more.