Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
IntellaMap Orion High Resolution Mapping Catheter Recalled by Boston Scientific Corp Due to Some IntellaMap Orion High Resolution Mapping Catheters are...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Boston Scientific Corp directly.
Affected Products
IntellaMap Orion High Resolution Mapping Catheter; Material number: M004RC64S0; Catalog number RC64S; Is indicated for electrophysiological mapping (recording or stimulating only) of the cardiac structures of the heart.
Quantity: 184 units
Why Was This Recalled?
Some IntellaMap Orion High Resolution Mapping Catheters are exhibiting a failure mode in which a glue bond on the Deployment Interlock Button has been observed to fail in the field.
Where Was This Sold?
This product was distributed to 4 states: AL, MA, NC, OK
About Boston Scientific Corp
Boston Scientific Corp has 7 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report