KYPHON Express KyphoPak Tray KPE1001Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000031800), received between Nov 18, 2020 and Sep 30, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (2 reports).

5 other recalls cover devices cleared under the same FDA submission (K041454); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2021Burst Container or Vessel; Burst Container or Vessel

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A BALLOON USED IN KYPHOPLASTY. PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE WAS COMPRESSION FRACTURE. IT WAS REPORTED THAT BALLOON POPPED AT 200PSI WITH VERY LITTLE RESISTANCE. BALLOON RUPTURED WHILE GETTING ACCESS TO OTHER PEDICLE. WAS INFLATED FOR ROUGHLY 5MIN AT 200PSI WITH 2CC¿S. THERE WAS NO PATIENT SYMPTOM REPORTED.  PROCEDURE COMPLETED SUCCESSFULLY WITH A NEW PRODUCT.  THERE WAS A DELAY IN OVERALL PROCEDURE TIME. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12553190 ↗
• MalfunctionNov 18, 2020Burst Container or Vessel; Burst Container or Vessel

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT INTRA-OP, BALLOON IMMEDIATELY RUPTURED UPON THE INFLATION PROCESS. WHILE PERFORMING KYPHOPLASTY, INFLATION BALLOON LEAKED. DYE WAS INJECTED INTO THE BALLOON AND 2ML LEAKED INTO OPERATIVE SITE WITHIN PATIENT. DOCTOR IMMEDIATELY WITHDREW DEVICE, AND CLEANED AREA WITH SALINE, AND WITHDRAW THE DYE. THERE WAS NO HARM TO THE PATIENT, AND THE CARE FINISHED WITHOUT ADDITIONAL INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10860180 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K041454. One submission often covers many models, so check the product and lot details in each record.

• Z-2390-2020 · Apr 24, 2020 · Terminated
  Medtronic Bone Void Filler, Small - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone void filler. The single-use Medtronic Bone Void Filler Kit c
• Z-2391-2020 · Apr 24, 2020 · Terminated
  Medtronic Bone Void Filler, Large - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone void filler. The single-use Medtronic Bone Void Filler Kit c
• Z-2389-2020 · Apr 24, 2020 · Terminated
  Extremities, Large Kit Assy, US, 15/3 - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone void filler. The single-use Medtronic Bone Void Filler Ki
• Z-3175-2011 · Mar 23, 2011 · Terminated
  Kyphon brand KyphoPak Express Tray First Fracture, 15/2 with KyphX Osteo Introducer System; Catalog Number: KPE1003; Product is manufactured and distributed by Medtronic Spine LLC
• Z-1209-2009 · Feb 4, 2009 · Terminated
  KyphX Xpander Inflatable Bone Tamp, size 15/3, Catalog Number K09A, Manufactured by Kyphon Sarl, Switzerland. For use in spinal surgery.