Balloon Kyphoplasty Essentials Kit NH152PB-CDSRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169703599), received between Aug 21, 2017 and Apr 24, 2026 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (2 reports).

5 other recalls cover devices cleared under the same FDA submission (K041454, K151532); 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 24, 2026Leak/Splash

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT DURING USE OF THE CDS KIT BALLOON, THE BALLOON WAS LEAKING CONTRAST FLUID DURING INFLATION. A SECOND BALLOON WAS OPENED AND USED. NO PATIENT SYMPTOMS OR COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE TYPE OF PROCEDURE/THERAPY INVOLVED DURING THE EVENT WAS BALLOON KYPHOPLASTY. THERE WAS NO BALLOON RUPTURE, IT ONLY LEAKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24977301 ↗
• MalfunctionMar 25, 2025Mechanical Jam; Mechanical Jam

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING A PRODUCT IDENTIFIED DURING AN EVENT. IT WAS REPORTED THAT BALLOON WAS STUCK. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP THAT NO HEALTH IMPACT ON PATIENT. SLOWED DOWN THE PROCEDURE DUE THIS EVENT AND CAUSED PHYSICIAN TO HAVE TO ACCESS A THIRD TIME IN ORDER TO PUT IN CEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21690536 ↗
• InjuryMar 12, 2025Leak/Splash; Product Quality Problem; No Flow; Leak/Splash; Product Quality Problem; No Flow

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR COMPRESSION FRACTURE. IT WAS REPORTED THAT DURING AN INTRA-OPERATIVE SPINAL PROCEDURE INVOLVING THE BONE CEMENT WITH MIXER, SEVERAL ISSUES AROSE WHEN REP WAS NOT IN THE EVENT. THE CEMENT WAS DESCRIBED AS RUNNY AND NOT DOUGHY AND HOMOGENOUS PRIOR TO DELIVERY, AND THE CEMENT GUN WAS LEAKING SALINE, PREVENTING THE ADVANCEMENT OF CEMENT INTO THE VERTEBRAL BODY. WHEN REP CAME BACK AND CHECKED THE ALLEGED DEVICES, IT LOOKED LIKE THE GUN WAS ADVANCING THE CEMENT, BUT THERE WASN'T ANY CEMENT IN THE PATIENT OR THE WEAPON. THIS LED TO THE ABANDONMENT OF THE CASE DUE TO PRODUCT FAILURE, AS THERE WAS NO BACKUP PRODUCT AVAILABLE. THE PROCEDURE WAS DELAYED, PROLONGING THE PATIENT'S EXISTING HOSPITALIZATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21583732 ↗
• InjuryMay 2, 2024Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCT THAT IS USED IN SPINAL THERAPY. IT WAS REPORTED THAT THE CDS GUN WOULD NOT GENERATE ENOUGH PRESSURE TO DELIVER EXPEDE CEMENT OUT OF CEMENT CARTRIDGE. THERE WERE NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THERE IS NO ISSUE WITH MDT CEMENT. SURGEON USED BONE FILLERS AND HV-R CEMENT SS AN UNINTENDED EQUIPMENT FOR COMPLETION OF SURGERY. THE CDS GUN PRIMED AS INTENDED BUT WHEN CONNECTED TO CEMENT CARTRIDGE WOULD NOT PROVIDE ENOUGH PRESSURE TO PUSH CEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19229185 ↗
• MalfunctionAug 21, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT PATIENT UNDERWENT BALLOON KYPHOPLASTY. INTRA-OP, BALLOON RUPTURED UPON INFLATION AT ONLY 200 PSI AND 1.5 CCS OF VOLUME. PATIENT WAS NOT ALLERGIC TO CONTRAST MEDIUM. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6806662 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K041454, K151532. 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.