Cable-Ready® 2232-04-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00889024039513), received between Feb 26, 2020 and Jul 27, 2026 — classified as 1 death, 36 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 reports).

1 other recall cover devices cleared under the same FDA submission (K151907); 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 25 most recent of 38 reports, in the reporter's own words as published by the FDA.

• DeathJul 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient underwent a knee surgery and subsequently passed away in the following days of the procedure, on an unknown date, due to unknown medical complications.Attempts have been made and no further information has been provided.

  Patient problems: Insufficient Information

  MAUDE report 50019159 ↗
• InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Unspecified Heart Problem

  MAUDE report 23822070 ↗
• InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Unspecified Heart Problem

  MAUDE report 23822066 ↗
• InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Unspecified Heart Problem

  MAUDE report 23822064 ↗
• InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Unspecified Heart Problem

  MAUDE report 23822062 ↗
• InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Unspecified Heart Problem

  MAUDE report 23822057 ↗
• InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Unspecified Heart Problem

  MAUDE report 23822054 ↗
• InjuryFeb 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP ARTHROPLASTY APPROXIMATELY TWO (2) MONTHS AGO. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY ONE (1) MONTH AGO DUE TO INSTABILITY.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 21426855 ↗
• InjuryDec 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Bone Fracture(s)

  MAUDE report 20832265 ↗
• InjuryDec 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 20820427 ↗
• InjuryDec 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 20820420 ↗
• InjuryDec 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 20820410 ↗
• InjuryDec 2, 2024Fracture; Migration; Fracture; Migration

  NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Discomfort

  MAUDE report 20819190 ↗
• InjurySep 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ADDITIONAL PROCEDURE APPROXIMATELY 4 MONTHS POST IMPLANTATION DUE TO CERCLAGE CABLES OCCLUDING THE SUPERFICIAL FEMORAL ARTERY. THE CABLES WERE REMOVED AND THE VESSEL WAS STENTED OPEN. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Foreign Body Embolism; Pain

  MAUDE report 17740764 ↗
• InjurySep 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ADDITIONAL PROCEDURE APPROXIMATELY 4 MONTHS POST IMPLANTATION DUE TO CERCLAGE CABLES OCCLUDING THE SUPERFICIAL FEMORAL ARTERY. THE CABLES WERE REMOVED AND THE VESSEL WAS STENTED OPEN. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Foreign Body Embolism; Pain

  MAUDE report 17740740 ↗
• InjurySep 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ADDITIONAL PROCEDURE APPROXIMATELY 4 MONTHS POST IMPLANTATION DUE TO CERCLAGE CABLES OCCLUDING THE SUPERFICIAL FEMORAL ARTERY. THE CABLES WERE REMOVED AND THE VESSEL WAS STENTED OPEN. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Foreign Body Embolism; Pain

  MAUDE report 17740738 ↗
• InjurySep 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ADDITIONAL PROCEDURE APPROXIMATELY 4 MONTHS POST IMPLANTATION DUE TO CERCLAGE CABLES OCCLUDING THE SUPERFICIAL FEMORAL ARTERY. THE CABLES WERE REMOVED AND THE VESSEL WAS STENTED OPEN. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Foreign Body Embolism; Pain

  MAUDE report 17740736 ↗
• InjurySep 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ADDITIONAL PROCEDURE APPROXIMATELY 4 MONTHS POST IMPLANTATION DUE TO CERCLAGE CABLES OCCLUDING THE SUPERFICIAL FEMORAL ARTERY. THE CABLES WERE REMOVED AND THE VESSEL WAS STENTED OPEN. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Foreign Body Embolism; Pain

  MAUDE report 17740734 ↗
• InjurySep 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ADDITIONAL PROCEDURE APPROXIMATELY 4 MONTHS POST IMPLANTATION DUE TO CERCLAGE CABLES OCCLUDING THE SUPERFICIAL FEMORAL ARTERY. THE CABLES WERE REMOVED AND THE VESSEL WAS STENTED OPEN. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Foreign Body Embolism; Pain

  MAUDE report 17740725 ↗
• InjurySep 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ADDITIONAL PROCEDURE APPROXIMATELY 4 MONTHS POST IMPLANTATION DUE TO CERCLAGE CABLES OCCLUDING THE SUPERFICIAL FEMORAL ARTERY. THE CABLES WERE REMOVED AND THE VESSEL WAS STENTED OPEN. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Foreign Body Embolism; Pain

  MAUDE report 17740708 ↗
• InjurySep 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ADDITIONAL PROCEDURE APPROXIMATELY 4 MONTHS POST IMPLANTATION DUE TO CERCLAGE CABLES OCCLUDING THE SUPERFICIAL FEMORAL ARTERY. THE CABLES WERE REMOVED AND THE VESSEL WAS STENTED OPEN. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Foreign Body Embolism; Pain

  MAUDE report 17740699 ↗
• InjurySep 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ADDITIONAL PROCEDURE APPROXIMATELY 4 MONTHS POST IMPLANTATION DUE TO CERCLAGE CABLES OCCLUDING THE SUPERFICIAL FEMORAL ARTERY. THE CABLES WERE REMOVED AND THE VESSEL WAS STENTED OPEN. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Foreign Body Embolism; Pain

  MAUDE report 17740695 ↗
• InjuryJun 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY TWO AND A HALF (2.5) MONTHS POST-IMPLANTATION DUE TO EXPERIENCING A PERIOPROSTHETIC BONE FRACTURE AFTER FALLING, AS WELL AS AN UNDERLYING INFECTION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Bone Fracture(s); Fall; Unspecified Infection

  MAUDE report 17191417 ↗
• InjuryJun 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY TWO AND A HALF (2.5) MONTHS POST-IMPLANTATION DUE TO EXPERIENCING A PERIOPROSTHETIC BONE FRACTURE AFTER FALLING, AS WELL AS AN UNDERLYING INFECTION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Bone Fracture(s); Fall; Unspecified Infection

  MAUDE report 17191409 ↗
• InjuryApr 13, 2023Fracture; Fracture

  NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Failure of Implant

  MAUDE report 16731299 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K151907. One submission often covers many models, so check the product and lot details in each record.

• Z-0327-2020 · Oct 10, 2019 · Terminated
  CABLE-READY SHORT GTR and CABLE-READY LONG GTR, Item Nos. 00223200201 00223200202