PROLENE W2790Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10705031126077), received between Aug 9, 2024 and Sep 18, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Material Separation” (6 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Material Separation

  It was reported that a patient underwent a Finger replantation procedure under brachial plexus anesthesia on (b)(6)2026 and suture was used. The patient underwent surgery at 18:06. The surgery began at 18:57 and at 22:10, when the surgeon used suture to anastomose the blood vessel, the interface between the needle and the suture broke. The traveling nurse unpacked another suture for the surgeon, and when the surgeon used a needle holder to clamp the suture, it broke again. The traveling nurse unpacked another suture and it broke during the surgeon use. Finally, the surgery used 5 suture (including 3 broken sutures) and 1 suture of another model. The surgery ended at 23:26. The patient returned to the ward at 23:29. No adverse patient consequences were reported. Additional information was requested

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50819510 ↗
• MalfunctionSep 18, 2026Material Separation

  It was reported that a patient underwent a Finger replantation procedure under brachial plexus anesthesia on (b)(6) 2026 and suture was used. The patient underwent surgery at 18:06. The surgery began at 18:57 and at 22:10, when the surgeon used suture to anastomose the blood vessel, the interface between the needle and the suture broke. The traveling nurse unpacked another suture for the surgeon, and when the surgeon used a needle holder to clamp the suture, it broke again. The traveling nurse unpacked another suture and it broke during the surgeon use. Finally, the surgery used 5 suture (including 3 broken sutures) and 1 suture of another model. The surgery ended at 23:26. The patient returned to the ward at 23:29. No adverse patient consequences were reported. Additional information was requested

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50819490 ↗
• MalfunctionSep 18, 2026Material Separation

  It was reported that a patient underwent a Finger replantation procedure under brachial plexus anesthesia on (b)(6)2026 and suture was used. The patient underwent surgery at 18:06. The surgery began at 18:57 and at 22:10, when the surgeon used suture to anastomose the blood vessel, the interface between the needle and the suture broke. The traveling nurse unpacked another suture for the surgeon, and when the surgeon used a needle holder to clamp the suture, it broke again. The traveling nurse unpacked another suture and it broke during the surgeon use. Finally, the surgery used 5 suture (including 3 broken sutures) and 1 suture of another model. The surgery ended at 23:26. The patient returned to the ward at 23:29. No adverse patient consequences were reported. Additional information was requested

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50819482 ↗
• MalfunctionJun 23, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN LEFT MIDDLE FINGER REPLANTATION SURGERY ON (B)(6) 2026 AND SUTURE WAS USED. AT 18:30 ON THE EVENING, THE SUTURE NEEDLE BROKE DURING THE ANASTOMOSIS OF BLOOD VESSELS, WHICH LED TO THE BROKEN END OF THE NEEDLE ENTERING THE PATIENT'S BODY. AFTER EXPLORATION AND C-ARM FLUOROSCOPY, IT WAS FOUND UNDER THE PATIENT'S SKIN TISSUE AND REPLACED WITH A NEW SUTURE FOR SUTURING. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25599228 ↗
• MalfunctionJun 1, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INTERNAL FIXATION SURGERY FOR RIGHT MIDDLE FINGER BONE FRACTURE PROCEDURE ON (B)(6) 2026, AND SUTURE WAS USED. DURING THE SURGERY, IT WAS NECESSARY TO PERFORM ARTERIOVENOUS ANASTOMOSIS UNDER A MICROSCOPE. THE SUTURE WAS OPENED AND PLACED ON THE OPERATING TABLE FOR VASCULAR SUTURING. WHEN PULLED, THE SUTURE BROKE AND THE SURGERY WAS PAUSED FOR A WHILE. THE DOCTOR USED ANOTHER SUTURE TO CONTINUE SUTURING. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25349853 ↗
• MalfunctionFeb 5, 2026Component Missing

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PTERYGIUM EXCISION SURGERY ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED FROM THE ANALYSIS OF THE RETURNED PRODUCT THAT WRONG AND/OR MIXED PACKAGING COMPONENT WAS OBSERVED. INCORRECT QUANTITY-MISSING PACKAGES. IT WAS REPORTED THAT THERE WAS ONE PACKAGE OF PRODUCT LESS THAN EXPECTED IN THE BOX WHEN JUST OPENED. THERE SHOULD BE TWELVE PACKAGES OF PRODUCTS IN THE BOX, BUT ACTUALLY THERE WERE ONLY ELEVEN PACKAGES OF PRODUCTS. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24267548 ↗
• MalfunctionJan 7, 2026Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, THE PATIENT WAS ADMITTED TO THE OUTPATIENT DEPARTMENT OF THE HOSPITAL FOR TREATMENT OF PTERYGIUM. FOLLOWING THE DOCTOR'S ADVICE, THE PATIENT WAS TREATED WITH EXCISION AND SUTURING. WHEN THE MEDICAL STAFF USED THE SUTURE TO SUTURE THE PATIENT, THE MEDICAL STAFF OPENED THE SUTURE PACKAGING AND FOUND THAT THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAD HAPPENED AND COULD NOT BE USED NORMALLY. THE DOCTOR IMMEDIATELY STOPPED USING THE SUTURE AND REPLACED IT WITH A NEW ONE. AFTER THE REPLACEMENT, THE PATIENT SUCCESSFULLY COMPLETED THE TREATMENT. THIS ADVERSE EVENT PROLONGED THE PATIENT'S SURGICAL TIME. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23995694 ↗
• MalfunctionAug 21, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT IT WAS IMMEDIATELY FOUND THAT THERE HAD BEEN FOREIGN MATTER (AS THE PHOTO SHOWS) IN THE NEWLY DISPENSED SUTURE DURING NORMAL CHECKING BY THE HOSPITAL. THE PACKAGE ISN'T OPENED. 3 PRODUCTS HAVE SAME ISSUE. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22860677 ↗
• MalfunctionAug 21, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT IT WAS IMMEDIATELY FOUND THAT THERE HAD BEEN FOREIGN MATTER (AS THE PHOTO SHOWS) IN THE NEWLY DISPENSED SUTURE DURING NORMAL CHECKING BY THE HOSPITAL. THE PACKAGE ISN'T OPENED. 3 PRODUCTS HAVE SAME ISSUE. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22860582 ↗
• MalfunctionAug 21, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT IT WAS IMMEDIATELY FOUND THAT THERE HAD BEEN FOREIGN MATTER (AS THE PHOTO SHOWS) IN THE NEWLY DISPENSED SUTURE DURING NORMAL CHECKING BY THE HOSPITAL. THE PACKAGE ISN'T OPENED. 3 PRODUCTS HAVE SAME ISSUE. THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22860574 ↗
• MalfunctionAug 8, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN VASCULAR PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. AT 11:30 AM, THE SURGERY WENT SMOOTHLY. DURING THE VASCULAR SUTURING, THE PROBLEM OF PULLING OFF SUTURE NEEDLE HAPPENED, RESULTING IN THE LOSS OF THE NEEDLE. AFTER SEARCHING, THE MISSING NEEDLE WAS NOT FOUND. DURING THE OPERATION, A C-ARM X-RAY MACHINE WAS USED TO CHECK AND NO MISSING NEEDLE WAS FOUND IN THE SURGICAL CAVITY. THE MALFUNCTION CAUSED A PROLONGED SURGERY TIME, INCREASED SURGICAL RISKS, AND CAUSED PSYCHOLOGICAL PRESSURE ON MEDICAL STAFF. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22749766 ↗
• MalfunctionJun 12, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A NEUROSURGICAL VASCULAR BYPASS SURGERY ON (B)(6) 2025 AND SUTURE WAS USED. IT WAS REPORTED THAT NEEDLE PULL OFF ISSUE OCCURRED DURING SEWING VESSEL IN THE NEUROSURGICAL VASCULAR BYPASS SURGERY. THE NEEDLE WAS MISSING AND IT COULD NOT FIND THE NEEDLE LOCATION EVEN WITH THE HELP OF X-RAY. IT'S UNKNOWN IF THE NEEDLE FELL INTO PATIENT OR NOT. THE OPERATION DELAYED ABOUT 80 MINUTES. NO CLINICAL CONSEQUENCES YET, IT'S STILL ONGOING FOLLOW-UP ABOUT PATIENT'S STATUS. NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22195627 ↗
• MalfunctionAug 9, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE SURGERY, THE DOCTOR OPENED A PACKAGE OF SUTURE, AND THE NEEDLE AND SUTURE WERE NOT ON THE REGULAR SPONGE PAD BUT RAN OUTSIDE THE PAPER PACKAGING. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19948956 ↗

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-2454-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879
• Z-2462-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844
• Z-2460-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4"(10CM) 8-0 BLUE, D9662
• 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-2466-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE 122CM M1.5, D10189
• Z-2451-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416
• Z-2457-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688
• Z-2456-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647
• Z-2464-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
• Z-2465-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027
• Z-2455-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292
• Z-2448-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031

…and 6 more.