KYPHON Xpander™ Inflatable Bone Tamp K08A (UDI 00643169103054)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00643169103054), received between Sep 28, 2017 and Apr 17, 2019 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PATIENT UNDERWENT BALLOON KYPHOPLASTY DUE TO OSTEOPOROTIC VERTEBRAL FRACTURES AT THREE LUMBAR VERTEBRAE. INTRA-OP, WHILE INFLATING THE BALLOON, LEAK OF CONTRAST MEDIUM INSIDE THE VERTEBRAL BODY WAS OBSERVED. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO FRAGMENT OF THE BALLOON REMAINED INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8523541 ↗
• MalfunctionOct 23, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH OSTEOPOROTIC L2 VERTEBRAL FRACTURE AND UNDERWENT BALLOON KYPHOPLASTY (BKP) PROCEDURE. DURING SURGERY, WHILE INFLATING THE BALLOON, AT 200 PSI, DIFFUSION OF CONTRAST MEDIUM WAS DETECTED. UPON DEFLATION AND VISUAL INSPECTION, IT REVEALED THAT THERE WAS A TEAR AT THE BALLOON. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7993955 ↗
• MalfunctionJul 18, 2018Material Rupture

  IT WAS REPORTED THAT INTRA-OPERATIVELY THE IBT BALLOON RUPTURE DURING INFLATION. THE DEVICE CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7697632 ↗
• MalfunctionMar 8, 2018Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE PATIENT UNDERWENT KYPHOPLASTY PROCEDURE AT L1 DUE TO OSTEOPOROSIS AND VERTEBRAL BODY FRACTURE L1. INTRA-OP, IT WAS NOT POSSIBLE TO INTRODUCE THE BALLOON ON THE RIGHT SIDE OF THE VERTEBRAL BODY COMPLETELY THROUGH THE INTRODUCER. THE BALLOON STOPPED AFTER ABOUT 2 CM. THE OPERATION WAS SUCCESSFULLY COMPLETED WITH NEW ONE. THE DEVICE CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7323630 ↗
• MalfunctionJan 25, 2018Fluid/Blood Leak; Material Rupture; Fluid/Blood Leak; Material Rupture

  THE CONTRAST LEAKED INTO THE PATIENT. NO FRAGMENTS LEFT IN THE VERTEBRAL BODY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7217894 ↗
• MalfunctionOct 4, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT ON (B)(6) 2017, INTRA OP, THE BALLOON WAS LEAKING FROM THE "STOP COCK" CONNECTION. DUE TO THE LEAK, THE INFLATION DEVICE HAD AIR IN THE SYSTEM. WHEN TRYING TO RELEASE THE AIR, THE READING OF THE DEVICE CHANGED. WHEN THE SURGEON WAS INFLATING THE TWO BALLOONS, THEY WERE INFLATING, BUT GIVING AN INCORRECT READING. THE RESULT IS THAT THE BKP TAMP BALLOON RUPTURED DUE TO THE PRESSURE ACCEDING THE ATM BURST PRESSURE. THE RUPTURED BALLOONS WERE REMOVED. SURGEON WAS ABLE TO INSERT ANOTHER BKP TRAY¿S BALLOON SYSTEM. THE CASE WAS COMPLETED WITH NO OTHER ISSUES. NO PATIENT COMPLICATION WAS REPORTED AS A RESULT OF THIS EVENT. NO FRAGMENTS OF THE BALLOON REMAINED INSIDE THE PATIENT'S BODY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6914456 ↗
• MalfunctionOct 4, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT ON (B)(6) 2017, INTRA OP, THE BALLOON WAS LEAKING FROM THE "STOP COCK" CONNECTION. DUE TO THE LEAK, THE INFLATION DEVICE HAD AIR IN THE SYSTEM. WHEN TRYING TO RELEASE THE AIR, THE READING OF THE DEVICE CHANGED. WHEN THE SURGEON WAS INFLATING THE TWO BALLOONS, THEY WERE INFLATING, BUT GIVING AN INCORRECT READING. THE RESULT IS THAT THE BKP TAMP BALLOON RUPTURED DUE TO THE PRESSURE ACCEDING THE ATM BURST PRESSURE. THE RUPTURED BALLOONS WERE REMOVED. SURGEON WAS ABLE TO INSERT ANOTHER BKP TRAY¿S BALLOON SYSTEM. THE CASE WAS COMPLETED WITH NO OTHER ISSUES. NO PATIENT COMPLICATION WAS REPORTED AS A RESULT OF THIS EVENT. NO FRAGMENTS OF THE BALLOON REMAINED INSIDE THE PATIENT'S BODY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6914013 ↗
• MalfunctionSep 28, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT BALLOON KYPHOPLASTY (BKP) AT L3 DUE TO VERTEBRAL FRACTURE. DURING THE SURGERY, AT THE PRESSURE OF 220 PSI THE BALLOON BURST. NO FRAGMENT OF THE BALLOON REMAINED IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS THE RESULT OF THIS EVENT. THE PATIENT WAS NOT ALLERGIC TO CONTRAST MEDIUM. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE ORIGINAL PRODUCT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6899941 ↗

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.