Spinal Decompression System Recalled for Potential Weld Breakage
Boston Scientific is recalling 175 Superion Indirect Decompression System devices due to potential weld breakage at the spindle cap that may prevent proper deployment during implantation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported injuries, deaths, or confirmed harm. The device exhibits a potential weld defect that could prevent proper deployment during spinal surgery, representing a theoretical risk without documented incidents. Per the rubric, theoretical hazards with no reported illness cap at Score 3 (High).
Plain-English summary
Boston Scientific Neuromodulation Corporation is recalling 175 units of the Superion Indirect Decompression System (IDS), a spinal decompression medical device. The recall affects three model sizes: 101-9808 (8mm), 101-9812 (12mm), and 101-9814 (14mm), with specific lot numbers identified for each model.
The devices are being recalled due to a potential for weld breakage at the spindle cap-to-main body interface. If the spindle cap separates from the main body during implantation, the device may not deploy properly, which could prevent the surgical procedure from being completed as intended.
The recalled devices were distributed nationwide across 33 states including Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Louisiana, Michigan, Minnesota, Mississippi, North Carolina, North Dakota, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Texas, Utah, Wisconsin, West Virginia, and Wyoming.
The recalled product
- Product
- Superion¿ Indirect Decompression System (IDS) Model Numbers and Size: 101-9808 - 8mm 01-9812 - 12mm 101-9814 - 14mm
- Manufacturer
- Boston Scientific Neuromodulation Corporation
- Affected units
- 175
Distribution
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