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KYPHON Express Inflatable Bone Tamp K15ARecalls & reported problems

Medtronic Sofamor Danek, Inc. · TAMP K15A IBT KYPHX EXPRESS SIZE 10/2 · Class 2

All models of KYPHON Express Inflatable Bone Tamp (9)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
4
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000025618), received between May 22, 2019 and Jul 3, 2020 — classified as 4 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 16, 2026.

Most reported problems

Device problems

  • Material Rupture4

Patient problems

  • No Known Impact Or Consequence To Patient4

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJul 3, 2020Material Rupture; Material Rupture

    PRE-OPERATIVE DIAGNOSIS:COMPRESSION FRACTURE PROCEDURE: KYPHOPLASTY LEVELS TREATED : T8 INTRA-OP, BALLOON POPPED(RUPTURED) WHILE INFLATING IN THE PATIENT¿S T8 VERTEBRAL BODY. THE MAXIMUM VOLUME WAS 2CC¿S WITH A PRESSURE OF 150PSI. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE ORIGINAL PRODUCT. THERE WAS NO DELAY IN OVERALL PROCEDURE TIME. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 10229109 ↗
  • MalfunctionOct 28, 2019Material Rupture; Material Rupture

    IT WAS REPORTED THAT THE PATIENT UNDERWENT BALLOON KYPHOPLASTY AT L5 DUE TO FRACTURE. INTRA-OP, DURING INFLATION, THE BALLOON OF THE INFLATABLE BONE TAMP (IBT) BURST AT 200 PSI. THIS WAS THE SECOND BALLOON THAT RUPTURED DURING THIS CASE. HENCE, THE CASE WAS ABLE TO BE COMPLETED WITH THE CAVITY THAT WAS CREATED BEFORE THE BALLOONS BURST. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9243509 ↗
  • MalfunctionOct 28, 2019Material Rupture; Material Rupture

    IT WAS REPORTED THAT THE PATIENT UNDERWENT BALLOON KYPHOPLASTY AT L5 DUE TO FRACTURE. INTRA-OP, DURING INFLATION, THE BALLOON OF THE INFLATABLE BONE TAMP (IBT) BURST AT 200 PSI. THE BALLOON WAS IMMEDIATELY DEFLATED AND WAS REPLACED WITH A SECOND IBT. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9243500 ↗
  • MalfunctionMay 22, 2019Material Rupture; Material Rupture

    IT WAS REPORTED THAT THE PATIENT UNDERWENT BALLOON KYPHOPLASTY AT L1 DUE TO VERTEBRAL COMPRESSION FRACTURE (VCF). INTRA-OP, UPON INFLATION THE IBT RUPTURED AT 150 PSI. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8630610 ↗

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.

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Sources and updates

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