PROLENE M8766Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10705031046160), received between Dec 23, 2019 and Jun 10, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Separation” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAFTING (CABG) ON (B)(6) 2024, AND SUTURE WAS USED ON THE VESSELS. DURING CONTINUOUS SUTURING ON THE PERIPHERAL SIDE, THE SUTURE WAS BROKEN THREE TIMES WHEN IN THE MIDDLE OF SUTURING OF VASCULAR ANASTOMOSIS. THE BROKEN PART WAS BETWEEN THE SUTURE, IT WAS NOT CONNECTION PART OF THE SUTURE AND NEEDLE. FURTHERMORE, WHEN PUT OUT THE SUBSTITUTE SUTURE, IT WAS ALSO BROKEN CONTINUOUSLY. IT OCCURRED EVEN THOUGH THE DOCTOR DID NOT GRABBED THE SUTURE WITH FORCEPS. IT WAS NOT A CONTROL RELEASE NEEDLE. THE OPERATION TIME WAS EXTENDED WITHIN THIRTY MINUTES. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19498158 ↗
• MalfunctionJun 10, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAFTING (CABG) ON (B)(6) 2024, AND SUTURE WAS USED ON THE VESSELS. DURING CONTINUOUS SUTURING ON THE PERIPHERAL SIDE, THE SUTURE WAS BROKEN THREE TIMES WHEN IN THE MIDDLE OF SUTURING OF VASCULAR ANASTOMOSIS. THE BROKEN PART WAS BETWEEN THE SUTURE, IT WAS NOT CONNECTION PART OF THE SUTURE AND NEEDLE. FURTHERMORE, WHEN PUT OUT THE SUBSTITUTE SUTURE, IT WAS ALSO BROKEN CONTINUOUSLY. IT OCCURRED EVEN THOUGH THE DOCTOR DID NOT GRABBED THE SUTURE WITH FORCEPS. IT WAS NOT A CONTROL RELEASE NEEDLE. THE OPERATION TIME WAS EXTENDED WITHIN THIRTY MINUTES. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19498136 ↗
• MalfunctionJun 10, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAFTING (CABG) ON (B)(6) 2024, AND SUTURE WAS USED ON THE VESSELS. DURING CONTINUOUS SUTURING ON THE PERIPHERAL SIDE, THE SUTURE WAS BROKEN THREE TIMES WHEN IN THE MIDDLE OF SUTURING OF VASCULAR ANASTOMOSIS. THE BROKEN PART WAS BETWEEN THE SUTURE, IT WAS NOT CONNECTION PART OF THE SUTURE AND NEEDLE. FURTHERMORE, WHEN PUT OUT THE SUBSTITUTE SUTURE, IT WAS ALSO BROKEN CONTINUOUSLY. IT OCCURRED EVEN THOUGH THE DOCTOR DID NOT GRABBED THE SUTURE WITH FORCEPS. IT WAS NOT A CONTROL RELEASE NEEDLE. THE OPERATION TIME WAS EXTENDED WITHIN THIRTY MINUTES. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19498119 ↗
• MalfunctionJan 6, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WAS UNEXPECTEDLY DISCONNECTED FROM THE SUTURE. A SIMILAR DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9554508 ↗
• MalfunctionJan 6, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WAS UNEXPECTEDLY DISCONNECTED FROM THE SUTURE. A SIMILAR DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9554377 ↗
• MalfunctionDec 23, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE NEEDLE WAS UNEXPECTEDLY DISCONNECTING FROM SUTURE. A SIMILAR DEVICE FROM A DIFFERENT LOT WAS USED TO COMPLETE THE CASE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9510670 ↗
• MalfunctionDec 23, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE NEEDLE WAS UNEXPECTEDLY DISCONNECTING FROM SUTURE. A SIMILAR DEVICE FROM A DIFFERENT LOT WAS USED TO COMPLETE THE CASE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9510659 ↗

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-2450-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988
• Z-2455-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292
• Z-2454-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879
• Z-2465-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027
• Z-2460-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662
• Z-2466-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE 122CM M1.5, D10189
• Z-2463-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995
• Z-2461-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746
• Z-2459-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067
• Z-2448-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031
• Z-2458-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
• Z-2464-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631

…and 6 more.