Catalyft PL Expandable Interbody SystemRecalls & reported problems across all models
Medtronic Sofamor Danek, Inc. · 16 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names at least one Catalyft PL Expandable Interbody System model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 279
- Deaths reported
- 0
- Injuries reported
- 64
- Recalls
- 1
We found 16 models of Catalyft PL Expandable Interbody System by Medtronic Sofamor Danek, Inc. in the FDA's device registry (GUDID). Together they are named in 279 adverse event reports in the FDA's MAUDE database, received between Aug 16, 2021 and Aug 17, 2026 — classified as 64 injuries, 215 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (175 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
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
Catalyft PL Expandable Interbody System 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.
- Sep 16, 2025Class IIOpen, Classified
Expandable interbody system cage may loose height or collapse (loss of lordosis), which could result in migration, subsidence and/or neurological injury. Therefore, surgical technique and instructions for use will be updated to mitigate risk of loss of lordosis to occur.
Z-0580-2026 · Root cause: Labeling design · names 12 of these models · Recall details · FDA record ↗
Most reported Catalyft PL Expandable Interbody System problems
Device problems
- Mechanical Problem175
- Migration60
- Mechanics Altered33
- Break19
- Adverse Event Without Identified Device or Use Problem5
- Migration or Expulsion of Device5
- Device Dislodged or Dislocated2
- Off-Label Use2
Patient problems
- No Clinical Signs, Symptoms or Conditions216
- Pain32
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available6
- Back pain6
- Inadequate Osseointegration6
- Unspecified Nervous System Problem5
- Device Embedded In Tissue or Plaque4
- Numbness4
Catalyft PL Expandable Interbody System models
16 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Catalyft PL Expandable Interbody System 6068073Intervertebral fusion device with bone graft, lumbar1 recall66 reports
- Catalyft PL Expandable Interbody System 6069076Intervertebral fusion device with bone graft, lumbar1 recall51 reports
- Catalyft PL Expandable Interbody System 6068076Intervertebral fusion device with bone graft, lumbar1 recall46 reports
- Catalyft PL Expandable Interbody System 6069096Intervertebral fusion device with bone graft, lumbar1 recall25 reports
- Catalyft PL Expandable Interbody System 6068093Intervertebral fusion device with bone graft, lumbar1 recall24 reports
- Catalyft PL Expandable Interbody System 6068096Intervertebral fusion device with bone graft, lumbar1 recall20 reports
- Catalyft PL Expandable Interbody System 6069073Intervertebral fusion device with bone graft, lumbar1 recall12 reports
- Catalyft PL Expandable Interbody System 6069093Intervertebral fusion device with bone graft, lumbar1 recall12 reports
- Catalyft PL Expandable Interbody System 6069116Intervertebral fusion device with bone graft, lumbar1 recall2 reports
- Catalyft PL Expandable Interbody System 6068113Intervertebral fusion device with bone graft, lumbar1 recall1 report
- Catalyft PL Expandable Interbody System 6068116Intervertebral fusion device with bone graft, lumbar1 recall1 report
- Catalyft PL Expandable Interbody System 6069113Intervertebral fusion device with bone graft, lumbar1 recall0 reports
- Catalyft PL Expandable Interbody System 6061002Intervertebral fusion device with bone graft, lumbar14 reports
- Catalyft PL Expandable Interbody System 6061000Intervertebral fusion device with bone graft, lumbar3 reports
- Catalyft PL Expandable Interbody System 6061001Intervertebral fusion device with bone graft, lumbar1 report
- Catalyft PL Expandable Interbody System NAV6061000Orthopedic stereotaxic instrument1 report
Recent Catalyft PL Expandable Interbody System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 17, 2026Migration
Information was received from clinical study, healthcare provider (HCP) via a manufacturer representative regarding a patient having Spinal therapy. It was reported that, at the Unscheduled 01 visit, Hardware Condition was adjudicated by MMI Imaging as one or more components of the fixation hardware has moved from its original location. There was only one cage was implanted and there was progressive dorsal displacement of intervertebral cage (L3-L4). There were no patient symptoms reported. No further complications reported regarding the event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50271056 ↗MalfunctionJul 7, 2026Difficult or Delayed Positioning; Mechanics Altered
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A SPACER USED FOR L3-5 SCREWS WITH L4/5 TRANSFORAMINAL LUMBAR INTERBODY FUSION WITH CATALYFT CAGES. IT WAS REPORTED THAT UPON INSERTION OF THE CAGE THE SURGEON ATTEMPTED TO EXPAND BUT THEEXPANSION DRIVER DID NOT ENGAGE AND WAS FREELY SPINNING. UNABLE TO EXPAND, SURGEON REMOVED THE CAGE AND IT WAS CHECKED FOR ANY ISSUES. USING THE EXPANSION DRIVER THE SCRUB NURSE WAS ABLE TO SUCCESSFULLY OPEN AND CLOSE THE CAGE. THE CAGE WAS THEN IMPLANTED A SECOND TIME; AND YET AGAIN THE TIP OF THE DRIVER WAS UNABLE TO ENGAGE WITH THE CAGE. THE DECISION WAS THEN MADE TO DISENGAGE THE CAGE FROM THE INSERTER TO FURTHER TROUBLESHOOT. UNFORTUNATELY, WHEN LATER TRYING TO RETHREAD THE CAGE ONTO THE REVISION SLEEVE THE CAGE MIGRATED ANTERIORLY AND BREACHED THE ANTERIOR DISC SPACE. DUE TO THE DANGEROUS POSITION, ONE AND HALF HOURS WAS LOST TRYING TO REVERSE THE CAGE WITH VARIOUS TOOLS AS THE REVISION SLEEVE COULD NOT BE ATTACHED. AFTER THE DELAY, THE PHYSICIAN WAS ABLE TO SUCCESSFULLY PULL THE CAGE BACK OUT ENTIRELY, TRIED EXPANDING AND COLLAPSING THE CAGE THEMSELVES AND THEN WERE ABLE TO REP OSITION AND INS
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25729848 ↗MalfunctionJul 6, 2026Mechanical Problem
INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE CAGES WOULDN'T EXPAND PROPERLY AND ONLY ONE DEFECTIVE CAGE WAS IMPLANTED AND IT WAS EXPLANTED AND REPLACED. 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 25713399 ↗InjuryMay 21, 2026Expulsion
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
Patient problems: Muscle Weakness/Atrophy; Numbness; Urinary Retention
MAUDE report 25240042 ↗InjuryMay 11, 2026Mechanical Problem; Migration
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A CATALYFT CAGE USED IN ANTERIOR LUMBAR INTERBODY FUSION AT LEVELS L4¿5. IT WAS REPORTED THAT DURING IMAGING CHECK UP, THE PHYSICIAN FOUND OUT THAT THE CAGE HAD COLLAPSED AND MIGRATED POSTERIORLY, THREE MONTHS POST-OPERATIVELY. THE PATIENT WAS ASYMPTOMATIC AT THE EVENT. A REVISION SURGERY, ALIF L4-5 AND REMOVAL OF CATALYFT CAGE WAS PERFORMED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED THAT THE CAGE WAS IMPLANTED IN A PROCEDURE OF TLIF(TRANSFORAMINAL LUMBAR INTERBODY FUSION.) AND ALIF( ANTERIOR LUMBAR INTERBODY FUSION AT LEVELS L4¿5 WAS THE REVISION SURGERY. THE MALFUNCTION WAS OBSERVED THROUGH IMAGING BY THE PHYSICIAN JUST BEFORE THE REVISION SURGERY DURING PATIENT'S THREE MONTH FOLLOW-UP. THE CAGE WAS EXPLANTED DURING THE REVISION PERFORMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25144822 ↗InjuryMar 12, 2026Mechanical Problem; Use of Device Problem; Migration
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT, THE CAGE COLLAPSED BY A FEW MILLIMETERS AND CAUSED IT TO MOVE WITHOUT ANY HARM TO THE PATIENT. SURGEON SAYS THAT WHEN THE CAGE IN QUESTION WAS IMPLANTED, HE DID NOT PERFORM THE PRACTICE OF MAKING THE TORQUE HANDLE CLICK AS AT THAT TIME, IT WAS NOT YET INDICATED AS BEING REQUIRED. LEVELS IMPLANTED WERE L5-S1. REVISION SURGERY WAS PERFORMED AND THE CAGE WAS EXPLANTED. THERE WAS NO PATIENT SYMPTOMS REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24578856 ↗MalfunctionMar 12, 2026Break
INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REP ORTED THAT THE TEETH BROKE OFF THE TIP. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24578001 ↗MalfunctionMar 12, 2026Mechanics Altered
INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR TRANSFORAMINAL LUMBAR INTE RBODY FUSION (TLIF). IT WAS REPORTED THAT THE INJECT INSERTER WILL NOT THREAD INTO INNER SLEEVE PIECE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24577338 ↗MalfunctionMar 11, 2026Break
INFORMATION WAS RECEIVED FROM REGULATORY BODY (RB), USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR TLIF INTERBODY INSERTION SPINAL THERAPY. IT WAS REPORTED THAT DEVICE WAS RUSTED AND BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED AND NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT INNER PORTION OF THE INSERTER HAS RUSTED OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24569340 ↗MalfunctionMar 6, 2026Break
INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REP ORTED THAT, THE DRIVER FROM THE CATALYFT INSTRUMENT SET WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24528964 ↗MalfunctionFeb 25, 2026Migration
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT DURING PATIENT FOLLOW-UP, A LATERAL X-RAY SHOWS THAT THE CAGE HAS MIGRATED. PROCEDURE PERFORMED WAS TRANSFORAMINAL LUMBAR INTERBODY FUSION. PATIENT IS ASYMPTOMATIC AT THIS TIME AND WILL RETURN IN A MONTH FOR ANOTHER FOLLOW UP VISIT. ADDITIONAL INFORMATION RECEIVED STATING PATIENT HAD A RECENT SCAN AND REMAINS ASYMPTOMATIC. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24438755 ↗MalfunctionFeb 24, 2026Use of Device Problem
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE SPACER DID NOT FIT CORRECTLY. THE PRODUCT WAS EXPLANTED. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PRPCEDURE WAS TLIF (TRANSFORAMINAL LUMBAR INTERBODY FUSION. WHEN THE IMPLANT WAS EXPANDED TO ITS MAX, THE DEVICE WAS NOT TIGHT ENOUGH IN THE DISC SPACE. THE SURGEON DIDN'T FEEL COMFORTABLE LEAVING. THEY REPLACED IT WITH A BIGGER CAGE. PROCEDURE WAS A SUCCESS ONCE WE RESIZED THE CAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24426166 ↗MalfunctionFeb 10, 2026Migration
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT BIOTH THE CAGES IMPINGED ONTO UPPER ENDPLATE OF L4/5 DISC PATIENT REPORTED CRAMPING LEG . THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: Cramp(s) /Muscle Spasm(s)
MAUDE report 24302453 ↗MalfunctionFeb 10, 2026Migration
ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE STATING THAT THE PROCEDURE INVOLVED WAS TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L4/5. NO REVISION SURGERY PLANNED.
Patient problems: Cramp(s) /Muscle Spasm(s)
MAUDE report 24302396 ↗MalfunctionFeb 9, 2026Mechanical Problem
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS IMPLANTED WITH SPACER IN L4/5 TRANSFORAMINAL LUMBAR INTERBODY FUSION. IT WAS REPORTED THAT AFTER THE TLIF PROCEDURE, THE CAGE HAS COLLAPSED. SINCETHE PATIENT IS NOT EXHIBITING ANY SYMPTOMS, IT HAS BEEN DECIDED TO MONITOR THE SITUATION AS IT IS. THE PHYSICIAN MENTIONED THAT MORE TORQUE SHOULD HAVE BEEN APPLIED. THE SURGERY WAS PERFORMED IN (B)(6) 2025, BUT IMAGING EVERY 3 MONTHS POSTOPERATIVELY SHOWS THAT THE CAGE IS GRADUALLY COLLAPSING. 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 24289356 ↗
Other Medtronic Sofamor Danek, Inc. products
- CD HORIZON Spinal System342 models · 2,323 reports
- GRAFTONand GRAFTON PLUSDemineralized Bone Matrix (DBM)25 models · 12 reports · 16 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
- INFINITY Occipitocervical Upper Thoracic System35 models · 63 reports · 5 recalls
- Catalyft LS Expandable Interbody System6 models · 3 reports · 6 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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