Balloon Kyphoplasty Essentials Kit NH152PBRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169703544), received between Feb 9, 2018 and May 30, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (1 report).

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 16, 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.

• MalfunctionMay 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT KYPHOPLASTY. POST-OP THE PATIENT'S VERTEBRAL BODY 'CRUMBLED'. REPORTEDLY THE PATIENT HAD SEVERE PAIN AFTER THE KYPHOPLASTY AND AS A RESULT REQUIRED CORPECTOMY AT THE LEVEL.

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 7552280 ↗
• MalfunctionFeb 9, 2018Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT UNSPECIFIED SURGERY. DURING SURGERY, THE BALLOON COULD NOT BE INFLATED OR FILLED WITH CONTRAST AGENT. EVEN OUTSIDE OF THE PATIENT, THE BALLOON COULD NOT BE INFLATED ALTHOUGH THE SCRUB TECH PREPPED THE BALLOON AND INFLATION SYRINGE PROPERLY BEFORE THE PROCEDURE. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. PATIENT COMPLICATIONS WERE REPORTED AS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7258606 ↗

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-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-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-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.