PROLENE D9060Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10705031031913), received between Apr 8, 2020 and Nov 15, 2023 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (12 reports).

21 other recalls cover devices cleared under the same FDA submission (K133356, K811872); 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 15, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED BY A SALES REP THAT, THERE WAS A TEAR IN THE PERFORATION OF THE VINYL SHRINK OF THE PRODUCT RECEIVED. THERE WAS NO DAMAGE TO THE MAILING BOX. THE PRODUCT BOX WAS NOT CRUSHED OR DENTED. WHEN THE SALES REP CHECKED THE PRODUCT, THE VINYL WAS UNDAMAGED AND THE PERFORATION ON THE BOX OPENING WAS SLIGHTLY OPEN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18144986 ↗
• MalfunctionNov 15, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED BY A SALES REP THAT, THERE WAS A TEAR IN THE PERFORATION OF THE VINYL SHRINK OF THE PRODUCT RECEIVED. THERE WAS NO DAMAGE TO THE MAILING BOX. THE PRODUCT BOX WAS NOT CRUSHED OR DENTED. WHEN THE SALES REP CHECKED THE PRODUCT, THE VINYL WAS UNDAMAGED AND THE PERFORATION ON THE BOX OPENING WAS SLIGHTLY OPEN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18144982 ↗
• MalfunctionNov 15, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED BY A SALES REP THAT, THERE WAS A TEAR IN THE PERFORATION OF THE VINYL SHRINK OF THE PRODUCT RECEIVED. THERE WAS NO DAMAGE TO THE MAILING BOX. THE PRODUCT BOX WAS NOT CRUSHED OR DENTED. WHEN THE SALES REP CHECKED THE PRODUCT, THE VINYL WAS UNDAMAGED AND THE PERFORATION ON THE BOX OPENING WAS SLIGHTLY OPEN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18144981 ↗
• MalfunctionNov 15, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED BY A SALES REP THAT, THERE WAS A TEAR IN THE PERFORATION OF THE VINYL SHRINK OF THE PRODUCT RECEIVED. THERE WAS NO DAMAGE TO THE MAILING BOX. THE PRODUCT BOX WAS NOT CRUSHED OR DENTED. WHEN THE SALES REP CHECKED THE PRODUCT, THE VINYL WAS UNDAMAGED AND THE PERFORATION ON THE BOX OPENING WAS SLIGHTLY OPEN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18144980 ↗
• MalfunctionNov 15, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED BY A SALES REP THAT, THERE WAS A TEAR IN THE PERFORATION OF THE VINYL SHRINK OF THE PRODUCT RECEIVED. THERE WAS NO DAMAGE TO THE MAILING BOX. THE PRODUCT BOX WAS NOT CRUSHED OR DENTED. WHEN THE SALES REP CHECKED THE PRODUCT, THE VINYL WAS UNDAMAGED AND THE PERFORATION ON THE BOX OPENING WAS SLIGHTLY OPEN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18144979 ↗
• MalfunctionNov 15, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED BY A SALES REP THAT, THERE WAS A TEAR IN THE PERFORATION OF THE VINYL SHRINK OF THE PRODUCT RECEIVED. THERE WAS NO DAMAGE TO THE MAILING BOX. THE PRODUCT BOX WAS NOT CRUSHED OR DENTED. WHEN THE SALES REP CHECKED THE PRODUCT, THE VINYL WAS UNDAMAGED AND THE PERFORATION ON THE BOX OPENING WAS SLIGHTLY OPEN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18144977 ↗
• MalfunctionNov 15, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED BY A SALES REP THAT, THERE WAS A TEAR IN THE PERFORATION OF THE VINYL SHRINK OF THE PRODUCT RECEIVED. THERE WAS NO DAMAGE TO THE MAILING BOX. THE PRODUCT BOX WAS NOT CRUSHED OR DENTED. WHEN THE SALES REP CHECKED THE PRODUCT, THE VINYL WAS UNDAMAGED AND THE PERFORATION ON THE BOX OPENING WAS SLIGHTLY OPEN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18144976 ↗
• MalfunctionNov 15, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED BY A SALES REP THAT, THERE WAS A TEAR IN THE PERFORATION OF THE VINYL SHRINK OF THE PRODUCT RECEIVED. THERE WAS NO DAMAGE TO THE MAILING BOX. THE PRODUCT BOX WAS NOT CRUSHED OR DENTED. WHEN THE SALES REP CHECKED THE PRODUCT, THE VINYL WAS UNDAMAGED AND THE PERFORATION ON THE BOX OPENING WAS SLIGHTLY OPEN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18144974 ↗
• MalfunctionNov 15, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED BY A SALES REP THAT, THERE WAS A TEAR IN THE PERFORATION OF THE VINYL SHRINK OF THE PRODUCT RECEIVED. THERE WAS NO DAMAGE TO THE MAILING BOX. THE PRODUCT BOX WAS NOT CRUSHED OR DENTED. WHEN THE SALES REP CHECKED THE PRODUCT, THE VINYL WAS UNDAMAGED AND THE PERFORATION ON THE BOX OPENING WAS SLIGHTLY OPEN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18144973 ↗
• MalfunctionNov 15, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED BY A SALES REP THAT, THERE WAS A TEAR IN THE PERFORATION OF THE VINYL SHRINK OF THE PRODUCT RECEIVED. THERE WAS NO DAMAGE TO THE MAILING BOX. THE PRODUCT BOX WAS NOT CRUSHED OR DENTED. WHEN THE SALES REP CHECKED THE PRODUCT, THE VINYL WAS UNDAMAGED AND THE PERFORATION ON THE BOX OPENING WAS SLIGHTLY OPEN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18144972 ↗
• MalfunctionNov 15, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED BY A SALES REP THAT, THERE WAS A TEAR IN THE PERFORATION OF THE VINYL SHRINK OF THE PRODUCT RECEIVED. THERE WAS NO DAMAGE TO THE MAILING BOX. THE PRODUCT BOX WAS NOT CRUSHED OR DENTED. WHEN THE SALES REP CHECKED THE PRODUCT, THE VINYL WAS UNDAMAGED AND THE PERFORATION ON THE BOX OPENING WAS SLIGHTLY OPEN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18144968 ↗
• MalfunctionNov 15, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED BY A SALES REP THAT, THERE WAS A TEAR IN THE PERFORATION OF THE VINYL SHRINK OF THE PRODUCT RECEIVED. THERE WAS NO DAMAGE TO THE MAILING BOX. THE PRODUCT BOX WAS NOT CRUSHED OR DENTED. WHEN THE SALES REP CHECKED THE PRODUCT, THE VINYL WAS UNDAMAGED AND THE PERFORATION ON THE BOX OPENING WAS SLIGHTLY OPEN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18144940 ↗
• MalfunctionApr 20, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN CARDIOVASCULAR SURGERY ON (B)(6)AND SUTURE WAS USED. THE SUTURE WAS DETACHED FROM THE NEEDLE IMMEDIATELY AS IF IT WERE A CONTROL RELEASE NEEDLE DURING SUTURE. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16781404 ↗
• MalfunctionApr 23, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON 3/30/2020 AND THE SUTURE WAS USED. THE SUTURE BROKE DURING USE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9989138 ↗
• MalfunctionApr 23, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON 3/30/2020 AND THE SUTURE WAS USED. THE SUTURE BROKE DURING USE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9989136 ↗
• MalfunctionApr 8, 2020Break; Break

  IT WAS REPORTED BY A SALES REP THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2020, THE SUTURE BROKE DURING USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9933972 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K133356, K811872. 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-2453-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
• Z-2462-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844
• Z-2454-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879
• Z-2463-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995
• Z-2458-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
• 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-2466-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE 122CM M1.5, D10189
• 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-2452-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748
• Z-2464-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
• Z-2449-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981

…and 6 more.