Reported Dec 17, 2014 · Terminated
IntellaMap Orion High Resolution Mapping Catheter; Material number: M004RC64S0; Catalog number RC64S; Is indicated for…
Boston Scientific Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Corp · 150 Baytech Dr · San Jose, CA · 95134-2302
Is this the product you have?
- IntellaMap Orion High Resolution Mapping Catheter
- Material numberM004RC64S0; Catalog number RC64S; Is indicated for electrophysiological mapping (recording or stimulating only) of the cardiac structures of the heart
- Lot codes and dates
- Lot numbers
170755501707598117083913170888261709408117101668172084451721846717251661172586171727493717292792and 17308586. Expiry Dates from June 252015 to September 242015
- Lot numbers
- Amount recalled
- 184 units
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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