PDS Z924HRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10705031114777), received between Jun 18, 2019 and Mar 4, 2026 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Material Separation” (12 reports).

3 other recalls cover devices cleared under the same FDA submission (K183183); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 4, 2026Break

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED BY A SALES REP THAT, THE SUTURE WAS BROKEN DURING USE. ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24512159 ↗
• MalfunctionMar 4, 2026Break

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED BY A SALES REP THAT, THE SUTURE WAS BROKEN DURING USE. ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24511995 ↗
• MalfunctionMar 4, 2026Break

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED BY A SALES REP THAT, THE SUTURE WAS BROKEN DURING USE. ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24506097 ↗
• MalfunctionMar 4, 2026Break

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. IT WAS REPORTED BY A SALES REP THAT, THE SUTURE WAS BROKEN DURING USE. ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24506094 ↗
• MalfunctionApr 24, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN BREAST AND ENDOCRINE SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, , WHEN HOLDING THE NEEDLE WITH THE NEEDLE-HOLDER, THE NEEDLE WAS UNUSUALLY BENT, AND IT WAS ALMOST BROKEN (IT HAS NOT BROKEN). IT WAS NOT A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THE PRODUCT WAS RETURNED FOR EVALUATION TO ETHICON. ONE PAPER LID, ONE EMPTY WINDING FORMER AND ONE NEEDLE-SUTURE OUTSIDE ITS PACKAGING WERE RECEIVED FOR ANALYSIS. PRODUCT CODE Z924H. EVALUATION OF THE RETURNED PRODUCT REVEALED A BROKEN NEEDLE, WITH A PORTION STILL ATTACHED TO THE SWAGE AREA, AND SIGNIFICANT TOOLING MARKS INDICATIVE OF DAMAGE FROM A SURGICAL INSTRUMENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21901583 ↗
• MalfunctionNov 26, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE HAD BEEN DETACHED FROM THE SUTURE. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION REQUESTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20781729 ↗
• MalfunctionNov 26, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE HAD BEEN DETACHED FROM THE SUTURE. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION REQUESTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20778647 ↗
• MalfunctionNov 26, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN 30 OCT 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE HAD BEEN DETACHED FROM THE SUTURE. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION REQUESTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20776888 ↗
• MalfunctionNov 25, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE HAD BEEN DETACHED FROM THE SUTURE. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION REQUESTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20773806 ↗
• MalfunctionNov 5, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ORTHOPEDIC PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING AN UNKNOWN ORTHOPEDIC SURGERY, THE JOINT BETWEEN THE SUTURE AND NEEDLE WAS DISCONNECTED. 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 20611691 ↗
• MalfunctionFeb 2, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN OTORHINOLARYNGOLOGY/HEAD AND THROAT SURGERY PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WAS EASILY DETACHED FROM THE SUTURE IMMEDIATELY WHEN STARTED USING THE PRODUCT. IT WAS A CONTROL RELEASE NEEDLE. THIS HAPPENED IN 2 PRODUCTS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18635348 ↗
• MalfunctionFeb 2, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN OTORHINOLARYNGOLOGY/HEAD AND THROAT SURGERY PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WAS EASILY DETACHED FROM THE SUTURE IMMEDIATELY WHEN STARTED USING THE PRODUCT. IT WAS A CONTROL RELEASE NEEDLE. THIS HAPPENED IN 2 PRODUCTS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18635344 ↗
• MalfunctionJan 31, 2024Break; Break

  IT WAS REPORTED THAT A PEDIATRIC PATIENT UNDERWENT CARDIAC SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING SUTURING OF ALL LAYERS OF THE ABDOMINAL CAVITY AND GASTROINTESTINAL TRACT USING A KNOT PUSHER, THE SUTURE BROKE ON THE SECOND LIGATION. SUBSEQUENTLY, ANOTHER LOT OF PRODUCT WAS USED. THE SURGEON COMMENTED, "I USUALLY USE 3-0, BUT THIS TIME I USED 4-0, SO THE SUTURE ITSELF WAS THINNER, WHICH MAY HAVE CONTRIBUTED TO THIS EVENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18612901 ↗
• MalfunctionJan 31, 2024Break; Break

  IT WAS REPORTED THAT A PEDIATRIC PATIENT UNDERWENT CARDIAC SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING SUTURING OF ALL LAYERS OF THE ABDOMINAL CAVITY AND GASTROINTESTINAL TRACT USING A KNOT PUSHER, THE SUTURE BROKE ON THE SECOND LIGATION. SUBSEQUENTLY, ANOTHER LOT OF PRODUCT WAS USED. THE SURGEON COMMENTED, "I USUALLY USE 3-0, BUT THIS TIME I USED 4-0, SO THE SUTURE ITSELF WAS THINNER, WHICH MAY HAVE CONTRIBUTED TO THIS EVENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18612900 ↗
• MalfunctionJan 13, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE PULLED OFF THE NEEDLE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11167457 ↗
• MalfunctionDec 16, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS FOUND THAT THE SUTURE HAD BEEN DETACHED FROM THE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9473586 ↗
• MalfunctionOct 18, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE SUTURE DETACHED FROM THE NEEDLE DURING SURGERY. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9207298 ↗
• MalfunctionJun 18, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN OTOLARYNGOLOGY HEAD AND NECK SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WAS DETACHED FROM THE SUTURE DURING USE. IT WAS NOT A CONTROL RELEASE NEEDLE. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8708319 ↗
• MalfunctionJun 18, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN OTOLARYNGOLOGY HEAD AND NECK SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE WAS DETACHED FROM THE SUTURE DURING USE. IT WAS NOT A CONTROL RELEASE NEEDLE. THE OPERATION TIME WAS EXTENDED WITHIN 30 MINUTES. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8708318 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K183183. One submission often covers many models, so check the product and lot details in each record.

• Z-1513-2025 · Mar 7, 2025 · Open, Classified
  PDSPLUSVIO30IN(75CM)USP6-0(M0.7)D/AC-1MP
• Z-0319-2025 · Sep 25, 2024 · Open, Classified
  Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358H
• Z-2146-2024 · May 10, 2024 · Open, Classified
  PDS II (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue, in microsurgery and in ophthalmic surgery.