IntellaMap Orion High Resolution Mapping Catheter recall
IntellaMap Orion High Resolution Mapping Catheter; Material number: M004RC64S0; Catalog number RC64S; Is indicated for electrophysiological mapping…
Why was IntellaMap Orion High Resolution Mapping Catheter 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot numbers: 17075550, 17075981, 17083913, 17088826, 17094081, 17101668, 17208445, 17218467, 17251661, 17258617, 17274937, 17292792, and 17308586. Expiry Dates from June 25, 2015 to September 24, 2015.
- Product
- IntellaMap Orion High Resolution Mapping Catheter; Material number: M004RC64S0; Catalog number RC64S; Is indicated for electrophysiological mapping…
- Recalling firm
- Boston Scientific Corp
- Quantity
- 184 units
- Distribution
- Worldwide Distribution -- US, including the states of MA, AL, NC, and OK; and, the countries of Germany, France, and Great Britain.
- Recall date
- December 17, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)