KYPHON Xpander Inflatable Bone TampRecalls & reported problems across all models
Medtronic Sofamor Danek, Inc. · 15 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 181
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls
- 1
We found 15 models of KYPHON Xpander Inflatable Bone Tamp by Medtronic Sofamor Danek, Inc. in the FDA's device registry (GUDID). Together they are named in 181 adverse event reports in the FDA's MAUDE database, received between Dec 13, 2016 and Dec 31, 2025 — classified as 5 injuries, 176 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (136 reports).
1 FDA recall record name at least one of these models by its device identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
KYPHON Xpander Inflatable Bone Tamp recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Feb 4, 2009Terminated
Product not sterile: 10 units were released for distribution without undergoing sterilization process.
Z-1209-2009 · Root cause: Process change control · Recall details · FDA record ↗
Most reported KYPHON Xpander Inflatable Bone Tamp problems
Device problems
- Material Rupture136
- Leak/Splash28
- Deflation Problem9
- Fluid/Blood Leak8
- Inflation Problem8
- Break3
- Burst Container or Vessel2
- Failure to Advance2
Patient problems
- No Known Impact Or Consequence To Patient134
- No Clinical Signs, Symptoms or Conditions34
- No Consequences Or Impact To Patient10
- Device Embedded In Tissue or Plaque3
- No Code Available2
- Extravasation1
- Foreign Body In Patient1
KYPHON Xpander Inflatable Bone Tamp models
15 models, most reported first. Each model has its own page with its reports, recalls and device details.
- KYPHON Xpander™ Inflatable Bone Tamp K09AARTHROSCOPE1 recall41 reports
- KYPHON Xpander Inflatable Bone Tamp K09AArthroscope35 reports
- KYPHON Xpander™ Inflatable Bone Tamp K09AArthroscope21 reports
- KYPHON Xpander™ Inflatable Bone Tamp K09AARTHROSCOPE17 reports
- KYPHON Xpander Inflatable Bone Tamp K08AArthroscope11 reports
- KYPHON Xpander™ Inflatable Bone Tamp K09AARTHROSCOPE9 reports
- KYPHON Xpander™ Inflatable Bone Tamp K08AArthroscope9 reports
- KYPHON Xpander™ Inflatable Bone Tamp K08AARTHROSCOPE8 reports
- KYPHON Xpander Inflatable Bone Tamp K13AArthroscope7 reports
- KYPHON Xpander™ Inflatable Bone Tamp K08AARTHROSCOPE7 reports
- KYPHON Xpander™ Inflatable Bone Tamp K13AARTHROSCOPE5 reports
- KYPHON Xpander™ Inflatable Bone Tamp K13AARTHROSCOPE4 reports
- KYPHON Xpander™ Inflatable Bone Tamp K13AArthroscope3 reports
- KYPHON Xpander™ Inflatable Bone Tamp K13AARTHROSCOPE2 reports
- KYPHON Xpander™ Inflatable Bone Tamp K08AARTHROSCOPE2 reports
Recent KYPHON Xpander Inflatable Bone Tamp adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionDec 23, 2025Material Rupture; Material Rupture
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING BALLOON KYPHOPL ASTY. IT WAS REPORTED THAT THE BALLOON HAS RUPTURED WHILE EXPANSION. 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 23875861 ↗MalfunctionSep 16, 2025Material Rupture; Material Rupture
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING BALLOON KYPHOPLASTY DUE TO PRIMARY OSTEOPOROSIS (COMPRESSION FRACTURE). IT WAS REPORTED THAT THE BALLOONWAS GRADUALLY INFLATED, AND WHEN THE 3 CC CONTRAST AGENT WAS REFILLED, THE BALLOON PRESSURE INCREASED TO 280 PSI. THE BALLOON RUPTURED WHILE WAITING FOR A WHILE, AND THE BALLOON PRESSURE DECREASED TO 0. THE BALLOON WAS REMOVED FROM THE DAMAGED IBT AND FILLED WITH CEMENT. 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 23061256 ↗MalfunctionSep 11, 2025Material Rupture; Material Rupture
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED IN A PAT IENT HAVING SPINAL THERAPY AT LEVELS L1-4. PREOP DIAGNOSIS - VERTEBRAL FRACTURE. IT WAS REPORTED THAT AFTER INFLATION THE BALLOON RUPTURED AND THE CONTRAST MEDIUM LEAKED FROM THE VERTEBRAE. THE SURGERY WAS PERFORMED SUCCESSFULLY WITH THE OTHER (SECOND) BALLOON AND PROCEEDED WITHOUT COMPLICATIONS. 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 23025197 ↗MalfunctionAug 29, 2025Material Rupture; Material Rupture
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR PRIMARY OSTEOPOROSIS - COMPRESSION FRACTURE. IT WAS REPORTED THAT THE BALLOON WAS RUPTURED DURING THE EXPANSION. 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 22920593 ↗MalfunctionJul 25, 2025Crack; Leak/Splash; Material Rupture; Crack; Leak/Splash; Material Rupture
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING KYPHOPLASTY AT L3 FOR PRIMARY OSTEOPOROSIS WITH A COMPRESSION FRACTURE (INTRASPINAL CLEFT). IT WAS REPORTED THAT THE RIGHT BALLOON WAS CRACKED AND RUPTURED DURING EXPANSION. THE CONTRAST AGENT LEAKAGE WAS CONFIRMED WHEN IT WAS TRIED TO INFLATE TO 3.5 CC; THE PSI WAS ALSO 0; IT WAS DETERMINED THAT THE BALLOON HAD SPLIT. THERE WAS NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22610570 ↗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 11, 2025Material Rupture; Material Rupture
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L3 BALLOON KYP HOPLASTY (BKP) FOR PRIMARY OSTEOPOROSIS (COMPRESSION FRACTURE). IT WAS REPORTED THAT THE BALLOON RUPTURED WITHOUT TRIGGER DURING BALLOON INFLATION. 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 22477664 ↗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 ↗MalfunctionMay 23, 2025Material Rupture; Material Rupture
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING LUMBAR LAMINOPL ASTY SPINAL THERAPY FOR PRIMARY OSTEOPOROSIS(COMPRESSION FRACTURE). LEVEL AT WHICH IMPLANT WAS PERFORMED IS L1. IT WAS REPORTED THAT THE BALLOON WAS RUPTURED WHEN THE BALLOON WAS INFLATED DURING THE INITIAL INSERTION. FLUSHED WITH SALINE, AND NO DEBRIS REMAINING IN THE BODY. 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 22076973 ↗MalfunctionMay 22, 2025Material Rupture; Material Rupture
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING BALLOON KYPHOPL ASTY PROCEDURE (TH12) DUE TO PRIMARY OSTEOPOROSIS ( COMPRESSION FRACTURE). IT WAS REPORTED THAT AFTER INSERTION, EXPANSION AND VERIFICATION OF THE FRONT AND SIDE VIEWS WERE PERFORMED. WHILE THE BALLOON WAS EXPANDED INSIDE THE BODY, CEMENT MIXING WAS CONDUCTED. UPON CHECKING THE CEMENT VISCOSITY AND AT THE TIMING OF DEFLATING THE BALLOON, BLOOD BACKFLOW INTO ONE OF THE IBTS WAS OBSERVED, INDICATING BALLOON DAMAGE. THE OTHER IBT WAS USED WITHOUT ANY ISSUES. SINCE NO CONTRAST MEDIUM SHADOW WAS DETECTED ON THE IMAGE IN THE FULLY DEFLATED STATE, IT WAS ASSUMED THERE WERE NO RESIDUALS INSIDE THE BODY, AND THE PROCEDURE WAS CONTINUED. IT WAS NOTED THAT SIGNIFICANT BONE SCLEROSIS HAD PROGRESSED, AND ONLY 1.5CC OF CEMENT COULD BE FILLED AT A TIME, LEADING THE PHYSICIAN TO COMMENT THAT THE BONE MIGHT HAVE BEEN HARD. BALLOON RUPTURED DURING CONTRACTION. PRE- RUPTURE PRESSURE WAS NOT 200 PSI OR GREATER. 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 22068349 ↗
Other Medtronic Sofamor Danek, Inc. products
- CD HORIZON Spinal System342 models · 2,323 reports
- GRAFTONand GRAFTON PLUSDemineralized Bone Matrix (DBM)25 models · 12 reports · 14 recalls
- METRx System5 models · 672 reports
- INFUSE Bone Graft6 models · 576 reports · 1 recall
- CD HORIZON SOLERA VOYAGER Spinal System60 models · 411 reports
- POWEREASE Instruments8 models · 331 reports · 1 recall
- Catalyft PL Expandable Interbody System16 models · 279 reports · 1 recall
- INFINITY Occipitocervical Upper Thoracic System35 models · 63 reports · 5 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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