KYPHON® Express™ Inflatable Bone Tamp K15ARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00858196001185), received between Feb 2, 2017 and Aug 30, 2019 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 30, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGERY DUE TO VERTEBRAL COMPRESSION FRACTURE. INTRA-OP, IBT RUPTURED DURING PROCEDURE. IBT RUPTURED AT 285 PSI. THERE WAS NO RESISTANCE AND BALLOON PRESSURE KEPT COMING DOWN WHEN INFLATED. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8949234 ↗
• MalfunctionAug 21, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH OSTEOPOROTIC FRACTURE AND UNDERWENT BALLOON KYPHOPLASTY. DURING THE SURGERY, BALLOON BROKE DURING INFLATION INSIDE THE VERTEBRA. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS THE RESULT OF THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7800453 ↗
• MalfunctionFeb 6, 2017Material Rupture; Material Rupture

  IT WAS REPORTED THAT PATIENT WITH VERTEBRAL COMPRESSION FRACTURE OF THE UNDERWENT KYPHOPLASTY. INTRA-OP, THE BALLOON RUPTURED IN THE VERTEBRAL BODY DURING DEFLATION. THE SURGEON LEFT THE BALLOON IN THE BONE WHILE WAITING FOR THE CEMENT TO BE READY FOR IMPLANTATION, AND THE BALLOON POPPED. ALL THE FRAGMENTS OF THE RUPTURED BALLOON WERE REMOVED FROM THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6306291 ↗
• InjuryFeb 2, 2017Disassembly; Material Rupture; Disassembly; Material Rupture

  IT WAS REPORTED THAT ON (B)(6) 2017, PATIENT UNDERWENT BALLOON KYPHOPLASTY AT T11 AND T12 FOR METASTATIC DISEASE WITH FRACTURE. INTR A-OP, THE BALLOON RUPTURED DURING DEFLATION <(>&<)> CAME OFF THE TAMP. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. RUPTURED BALLOON REMAINED INSIDE THE PATIENT'S T11 VERTEBRAL BODY. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6295381 ↗

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-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-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.