BALLOON KYPHOPLASTY ESSENTIALS NH153PBRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000031886), received between Aug 14, 2019 and Aug 14, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2019Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak; Leak/Splash

  IT WAS REPORTED THAT INTRA-OP, THE CONTRAST WAS LEAKING DOWN THE SHAFT OF THE INFLATABLE BONE TAMP (IBT). THE LEAK WAS LOCATED UNDERNEATH THE AREA OF THE SHAFT WHERE THE BALLOON SIZE IS MENTIONED. THE REPORTED IBT WAS REPLACED WITH A NEW ONE; AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8892656 ↗

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-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-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-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.