PDS Z127HRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10705031060227), received between Mar 5, 2019 and Apr 24, 2026 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Material Separation” (13 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Mar 7, 2025Open, Classified

   Identified curing issues with the silicone during the needles manufacturing process.

   Z-1514-2025 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 24, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RHINOPLASTY PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. THE PDS 6.0, 75 CM SUTURE IS BREAKING DURING THE RHINOPLASTY PROCEDURE: THE DOCTOR REPORTS DIFFICULTY SUTURING THE PATIENT DUE TO POOR SUTURE QUALITY. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24985442 ↗
• MalfunctionMar 28, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE DISTRIBUTOR PER CUSTOMER THAT PRODUCT WAS DEFECTIVE. THEY HAVE A BOX OF SUTURE (SPECIAL ORDER) THAT IS FAILING ON EVERY SUTURE THEY OPEN. THE NEEDLE IS POPPING OFF THE LINE. THERE WAS NO PATIENT CONSEQUENCES REPORTED. THE DEVICE IS AVAILABLE FOR RETURN. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21720737 ↗
• MalfunctionMar 28, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE DISTRIBUTOR PER CUSTOMER THAT PRODUCT WAS DEFECTIVE. THEY HAVE A BOX OF SUTURE (SPECIAL ORDER) THAT IS FAILING ON EVERY SUTURE THEY OPEN. THE NEEDLE IS POPPING OFF THE LINE. THERE WAS NO PATIENT CONSEQUENCES REPORTED. THE DEVICE IS AVAILABLE FOR RETURN. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21720735 ↗
• MalfunctionMar 28, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE DISTRIBUTOR PER CUSTOMER THAT PRODUCT WAS DEFECTIVE. THEY HAVE A BOX OF SUTURE (SPECIAL ORDER) THAT IS FAILING ON EVERY SUTURE THEY OPEN. THE NEEDLE IS POPPING OFF THE LINE. THERE WAS NO PATIENT CONSEQUENCES REPORTED. THE DEVICE IS AVAILABLE FOR RETURN. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21720732 ↗
• MalfunctionMar 28, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE DISTRIBUTOR PER CUSTOMER THAT PRODUCT WAS DEFECTIVE. THEY HAVE A BOX OF SUTURE (SPECIAL ORDER) THAT IS FAILING ON EVERY SUTURE THEY OPEN. THE NEEDLE IS POPPING OFF THE LINE. THERE WAS NO PATIENT CONSEQUENCES REPORTED. THE DEVICE IS AVAILABLE FOR RETURN. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21720730 ↗
• MalfunctionJan 15, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS BROKEN UPON USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21160414 ↗
• MalfunctionDec 26, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. THE SUTURE BROKE DURING SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21019804 ↗
• MalfunctionDec 26, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. THE SUTURE BROKE DURING SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21019796 ↗
• MalfunctionMar 8, 2024Material 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 NEEDLE AND SUTURE DISCONNECTED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18869135 ↗
• MalfunctionApr 8, 2022Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PLASTIC SURGERY ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURES WERE DETACHED AND BROKEN AT THE SWAGE PARTS DURING INTERRUPTED SUTURING. THIS HAPPENED IN A ROW. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14057574 ↗
• MalfunctionApr 8, 2022Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PLASTIC SURGERY (B)(6) 2022. AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURES WERE DETACHED AND BROKEN AT THE SWAGE PARTS DURING INTERRUPTED SUTURING. THIS HAPPENED IN A ROW. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14057556 ↗
• MalfunctionApr 8, 2022Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PLASTIC SURGERY ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURES WERE DETACHED AND BROKEN AT THE SWAGE PARTS DURING INTERRUPTED SUTURING. THIS HAPPENED IN A ROW. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14057526 ↗
• MalfunctionApr 8, 2022Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PLASTIC SURGERY (B)(6) 2022. AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURES WERE DETACHED AND BROKEN AT THE SWAGE PARTS DURING INTERRUPTED SUTURING. THIS HAPPENED IN A ROW. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14057524 ↗
• MalfunctionApr 8, 2022Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PLASTIC SURGERY ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURES WERE DETACHED AND BROKEN AT THE SWAGE PARTS DURING INTERRUPTED SUTURING. THIS HAPPENED IN A ROW. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14057517 ↗
• MalfunctionApr 8, 2022Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PLASTIC SURGERY (B)(6) 2022. AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURES WERE DETACHED AND BROKEN AT THE SWAGE PARTS DURING INTERRUPTED SUTURING. THIS HAPPENED IN A ROW. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14057509 ↗
• MalfunctionJul 17, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY IN 2020 AND THE SUTURE WAS USED TO CLOSE THE TISSUE. IT WAS REPORTED THAT THE SUTURE SEPARATED FROM THE NEEDLE DURING THE PROCEDURE. THE BREAKPOINT WAS IN THE JUNCTION BETWEEN NEEDLE AND SUTURE. ANOTHER LIKE SUTURE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10289023 ↗
• MalfunctionMar 5, 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, THE SUTURE 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 8390124 ↗