KYPHON Express Inflatable Bone Tamp K15BRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00763000025625), received between Aug 29, 2018 and May 12, 2020 — classified as 1 injury, 6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2020Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT THE PATIENT UNDERWENT UNKNOWN SURGERY. INTRA-OP, BALLOON FAILED TO INFLATE WITH CONTRAST. CONTRAST WAS LEAKING INTO VERTEBRAL BODY UNDER FLUOROSCOPY. IT WAS REPLACED WITH ANOTHER BALLOON OF THE SAME SIZE, AND THE PROCEDURE WAS COMPLETED. THE MALFUNCTION WAS DISCOVERED WHEN THE PHYSICIAN ATTEMPTED TO INFLATE THE BALLOON IN THE VERTEBRAE. THERE WERE NO PATIENT COMPLICATIONS, BUT CONTRAST LEAKED INTO THE VERTEBRAE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10045968 ↗
• MalfunctionMar 20, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH L1 VERTEBRAL COMPRESSION FRACTURE; AND UNDERWENT L1 BALLOON KYPHOPLASTY. INTRA-OP, WHILE RE-INTRODUCING THE INNER STYLET INTO THE BONE TAMP, THE BONE TAMP BURST INSIDE THE PATIENT. THE STYLET PIERCED THE INFLATED BALLOON. THE PROCEDURE WAS THEN COMPLETED SUCCESSFULLY WITH A NEW PRODUCT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9862812 ↗
• MalfunctionDec 25, 2019Inflation Problem; Device Slipped; Inflation Problem; Device Slipped

  IT WAS REPORTED THAT THE PATIENT UNDERWENT UNKNOWN SURGERY AT L1-L2 DUE TO 2 LEVEL COMPRESSION FRACTURE. INTRA-OP, THE BALLOON WOULD NOT EXPAND INITIALLY BECAUSE THE BAND ON THE PROXIMAL PORTION OF THE BALLOON THAT HAS THE SIZE OF THE KIT ON IT (15/2) WAS LOOSE. IT SLIDES UP AND DOWN SHAFT OF THE BALLOON AND COULD ACCIDENTALLY BE IMPLANTED IN THE PATIENT. IT WAS NOT NOTICED AND THE BALLOON WENT UP TO 700 PSI. LATER IT SLIPPED OUT OF THE BAND AND EXPANDED RAPIDLY. THERE WAS DELAY IN OVERALL PROCEDURE TIME AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE ORIGINAL PRODUCT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATION REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9517651 ↗
• InjuryAug 13, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT BALLOON KYPHOPLASTY DUE TO COMPRESSION FRACTURE. INTRA-OP, WHEN THE PHYSICIAN DEFLATED THE INFLATABLE BONE TAMP (IBT) AND WAS REMOVING IT, THE BALLOON PORTION DETACHED FROM THE IBT. THE BALLOON PORTION REMAINED IN THE VERTEBRAL BODY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8887333 ↗
• MalfunctionApr 19, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT BALLOON KYPHOPLASTY AT L4 DUE TO BONE FRACTURE. INTRA-OP, THE BALLOON RUPTURED DURING INFLATION AT 350 PSI. THE PATIENT WAS NOT ALLERGIC TO CONTRAST MEDIA. THE PROCEDURE WAS EVENTUALLY COMPLETED WITH A NEW PRODUCT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8531171 ↗
• MalfunctionAug 29, 2018Material Rupture; Material Rupture

  LEVELS IMPLANTED: L4. IT WAS REPORTED THAT INTRA-OPERATIVELY BOTH THE IBT BALLOON WERE RUPTURED DURING INFLATION AT LESS THAN 100PSI. 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 7825968 ↗
• MalfunctionAug 29, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT INTRA-OPERATIVELY BOTH THE BALLOONS RUPTURED DURING INFLATION AT LESS THAN 100PSI, AT VOLUME LESS THAN 3 ML. THE EXTRAVASATED CONTRAST WAS ASPIRATED FROM THE SURGICAL FIELD AND THE PROCEDURE WAS COMPLETED NORMALLY. THE BALLOONS WERE REMOVED AND FOUND TO BE INTACT WITH THE EXCEPTION OF PIN HOLES. THERE WAS NO EVIDENCE OF ANY INJURY THAT OCCURRED DUE TO THE EXTRAVASATED CONTRAST.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7825958 ↗

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.