In September 2025, Medtronic initiated an Urgent Medical Device Correction related to its Catalyft™ PL and PL40 expandable interbody systems, aimed at mitigating the risk of post-implantation loss of lordosis, also described as loss of height or cage collapse.
The correction was initiated on September 16, 2025, and posted publicly on November 21, 2025, following internal review and evaluation. The action applies to affected geographies including the Americas, EMEA, and APAC.
Medtronic confirmed that the Catalyft™ PL & PL40 systems meet all design and manufacturing specifications and remain available for use. The correction does not represent a recall, but rather an update to labeling and surgical guidance intended to mitigate known risks associated with expandable interbody cages.
Description of the Issue
The Catalyft™ PL & PL40 implants are designed to be inserted into the disc space in a closed configuration and expanded in situ to achieve the desired lordosis as an adjunct to spinal fusion procedures. Loss of lordosis and subsidence are known risks associated with expandable interbody implants.
According to Medtronic, the majority of reported cases were asymptomatic, identified during routine post-operative imaging. In some cases, patients required revision surgery, primarily due to pain or pseudoarthrosis.
Updates to IFU and Surgical Technique
Medtronic is implementing several updates, including:
- Addition of loss of lordosis and subsidence to the Adverse Events section of the Instructions for Use (IFU).
- Updates to the Surgical Technique Guide emphasizing:
- Anterior cage placement on the apophyseal ring
- Adequate implant loading and torque during expansion
- Posterior compression to optimize endplate engagement
- Appropriate cage sizing
- Intra-operative imaging confirmation
These measures are intended to improve implant stability, endplate contact, and long-term alignment.
Patient Management
For patients already implanted with Catalyft™ PL or PL40 devices, no additional actions are recommended beyond standard post-operative follow-up. If loss of lordosis is identified, clinical management should be based on the patient’s overall medical condition. loss of lordosis is identified, clinical management should be based on the patient’s overall medical condition.
About Medtronic
A global healthcare technology leader — boldly attacking the most challenging health problems facing humanity with innovations that transform lives.Website: http://www.medtronic.com
Resources:
- Catalyft-pl-pl40-expandable-interbody-system-cage-Recall.pdf
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=216383
- Catalyft-pl-Brochure.Medtronic.pdf
- Catalyft Video Animation
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