PROLENE 9706HRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10705031022881), received between Nov 25, 2019 and Aug 5, 2025 — classified as 1 death, 8 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• DeathAug 5, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG W/ PFO CLOSURE VIA RIGHT ATRIOTOMY ON (B)(6) 2025 DUE TO CORONARY ARTERY DISEASE W/ CRYPTOGENIC STROKE IN (B)(6). AND SUTURE WAS USED. THE SURGEON WAS SUPPOSED TO CLOSE THE RIGHT ATRIUM AND THE PFO. HOWEVER, THE RIGHT ATRIUM REPORTEDLY BLEW, POTENTIALLY DUE TO A SUTURE FAILURE, CAUSING THE PATIENT TO PASS AWAY. THE CAUSE OF DEATH WAS THAT THE PATIENT ARRESTED IN THE ICU DUE TO EXSANGUINATING HEMORRHAGE THAT HAPPENED AND THE PATIENT HAD SUDDEN BLEEDING OUT OF CHEST TUBES. THE SURGEON OPENED THE CHEST IN THE ICU, REPAIRED THE RIGHT ATRIUM. THE PATIENT WAS NOT ABLE TO BE REVIVED. SURGEON EXPLORED THE SITE OF INJURY/REPAIR AND WAS NOT ABLE TO FIND THE SUTURE. NOT TISSUE WEAKNESS OBSERVED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Failure to Anastomose; Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury

  MAUDE report 22710833 ↗
• MalfunctionApr 17, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURES BROKE WHILE SEWING IN SURGERY. NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21861967 ↗
• MalfunctionApr 17, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURES BROKE WHILE SEWING IN SURGERY. NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21861003 ↗
• MalfunctionAug 5, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE KEPT SNAPPING. ANOTHER LIKE DEVICE WAS USED WITH NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19913104 ↗
• MalfunctionAug 5, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE KEPT SNAPPING. ANOTHER LIKE DEVICE WAS USED WITH NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19912954 ↗
• MalfunctionNov 25, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A WHIPPLE PROCEDURE ON (B)(6) 2019 AND THE SUTURE WAS USED. IT WAS REPORTED THAT DURING SURGERY, WHILE PERFORMING THE VASCULAR ANASTOMOSIS, THE NEEDLE FRACTURED IN HALF NEAR THE SWAGE, CREATING NEEDLE HOLE BLEEDING AT THE VESSEL SITE. THE DOCTOR WAS ABLE TO RETRIEVE THE NEEDLE PIECES. THE PROCEDURE WAS COMPLETED USING A LIKE DEVICE FROM ANOTHER LOT. IT WAS ALSO REPORTED THAT THE PROCEDURE WAS DELAYED BY THIRTY MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: Blood Loss

  MAUDE report 9372502 ↗
• MalfunctionNov 25, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A WHIPPLE PROCEDURE ON (B)(6) 2019 AND THE SUTURE WAS USED. IT WAS REPORTED THAT DURING SURGERY, WHILE PERFORMING THE VASCULAR ANASTOMOSIS, THE NEEDLE FRACTURED IN HALF NEAR THE SWAGE, CREATING NEEDLE HOLE BLEEDING AT THE VESSEL SITE. THE DOCTOR WAS ABLE TO RETRIEVE THE NEEDLE PIECES. THE PROCEDURE WAS COMPLETED USING A LIKE DEVICE FROM ANOTHER LOT. IT WAS ALSO REPORTED THAT THE PROCEDURE WAS DELAYED BY THIRTY MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: Blood Loss

  MAUDE report 9372499 ↗
• MalfunctionNov 25, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A WHIPPLE PROCEDURE ON (B)(6) 2019 AND THE SUTURE WAS USED. IT WAS REPORTED THAT DURING SURGERY, WHILE PERFORMING THE VASCULAR ANASTOMOSIS, THE NEEDLE FRACTURED IN HALF NEAR THE SWAGE, CREATING NEEDLE HOLE BLEEDING AT THE VESSEL SITE. THE DOCTOR WAS ABLE TO RETRIEVE THE NEEDLE PIECES. THE PROCEDURE WAS COMPLETED USING A LIKE DEVICE FROM ANOTHER LOT. IT WAS ALSO REPORTED THAT THE PROCEDURE WAS DELAYED BY THIRTY MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: Blood Loss

  MAUDE report 9372495 ↗
• MalfunctionNov 25, 2019Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON AN UNKNOWN DATE IN 2019 AND THE SUTURE WAS USED. IT WAS REPORTED THAT WHEN THE BOX WAS RECEIVED A PACKAGE WAS OPENED AND THE NEEDLES WERE DIFFERENT THAN WHAT WAS ORDERED. IT WAS ALSO REPORTED THAT VIEWING THE SUTURE FROM THE OUTSIDE OF THE PACKAGE DOES NOT LOOK LIKE IT'S HEMOSEAL TECHNOLOGY, IT DOES NOT LOOK LIKE IT GOES DOWN TO THE SEWAGE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9372258 ↗

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-2466-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE 122CM M1.5, D10189
• Z-2461-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746
• Z-2449-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981
• Z-2463-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995
• Z-2450-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988
• Z-2462-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844
• Z-2453-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
• 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-2465-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027
• Z-2451-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416
• Z-2458-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
• Z-2455-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292

…and 6 more.