KYPHON Xpander™ Inflatable Bone Tamp K08A (UDI 00763000311902)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00763000311902), received between Sep 14, 2021 and Dec 31, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (9 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 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 31, 2025Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING AN UNKNOWN SPINAL KYPHOPLASTY PROCEDURE IN A PATIENT. IT WAS REPORTED THAT THE BALLOON COULDN'T GET THROUGH THE OSTEOINDUCER. IT WAS TOO THICK AND THE OTHER BALLOON RUPTURED. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23932260 ↗
• MalfunctionDec 31, 2025Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A L2 BKP PROCEDURE IN A PATIENT DIAGNOSED WITH COMPRESSION FRACTURE DUE TO PRIMARY OSTEOPOROSIS. IT WAS REPORTED THAT THE BALLOON BURST. THERE WAS A DELAY OF LESS THAN 60 MINS. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23932252 ↗
• MalfunctionJul 21, 2025Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT HAVING SPINAL THERAPY FOR VERTEBRAL FRACTURE. IT WAS REPORTED THAT THE BALLOON HAS BURST. IT WAS UNKNOWN IF THERE WERE PATIENT SYMPTOMS. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22553236 ↗
• MalfunctionJul 21, 2025Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT HAVING SPINAL THERAPY FOR VERTEBRAL FRACTURE. IT WAS REPORTED THAT THE BALLOON HAS BURST. IT WAS UNKNOWN IF THERE WERE PATIENT SYMPTOMS. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22553230 ↗
• MalfunctionJul 7, 2025Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT HAVING SPINAL THERAPY FOR VERTEBRAL FRACTURE. IT WAS REPORTED THAT BALLOONS HAVE BURST. BOTH WERE FROM ONE BATCH. IT WAS UNKNOWN IF THERE WERE PATIENT SYMPTOMS. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22409854 ↗
• MalfunctionJul 4, 2025Material Rupture; Material Rupture

  ON 2025 SEP 16, UPDATE RECEIVED: NO IMPLANT WAS PERFORMED AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22403450 ↗
• MalfunctionJun 6, 2025Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR OSTEOPOROSIS VERTEBRA COMPRESSION FRACTURE. IT WAS REPORTED THAT A BALLOON BURST DURING INFLATION. THE EVENT OCCURRED INTRA-OPERATIVELY AND THERE WAS NO DELAY IN OVERALL PROCEDURE TIME. DESPITE THE BALLOON DEFECT, THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A NEW PRODUCT. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22155949 ↗
• MalfunctionApr 22, 2025Material Rupture; Mechanical Jam; Material Rupture; Mechanical Jam

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L2 BALLOON KYP HOPLASTY DUE TO COMPRESSION FRACTURE. IT WAS REPORTED THAT THE BALLOON GOT LODGED INSIDE THE TROCAR AND WAS UNABLE TO BE PULLED OUT, THE TROCAR STYLET WAS REMOVED, THE INTELIFLATOR WAS REMOVED AND THE LOCKING SYRINGE WAS UTILIZED TO REMOVE ANY EXCESS FLUID, THE WHOLE TROCAR HAD TO BE REMOVED AND A NEW ONE INSERTED. BALLOON RUPTURED DURING DEFLATION. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21879737 ↗
• MalfunctionSep 14, 2021Material Rupture; Material Rupture

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING BONE TAMP. IT WAS REPORTED THAT BALLOON RUPTURED IN THE BODY OF THE VERTEBRA DURING INFLATION BUT IT WAS EASY TO TAKE IT OUT. A NEW BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12465912 ↗

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.