Boston Scientific Recalls IntellaMap Orion Mapping Catheters Due to Glue Failure
Boston Scientific is recalling 184 IntellaMap Orion High Resolution Mapping Catheters because a glue bond on the Deployment Interlock Button may fail.
What this means for you
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: The recall is classified as FDA Class II. The hazard involves a mechanical failure of a safety interlock on a medical device used in cardiac procedures, which poses a risk of harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Boston Scientific Corp is recalling 184 units of the IntellaMap Orion High Resolution Mapping Catheter (Material number: M004RC64S0; Catalog number RC64S). The device is indicated for electrophysiological mapping of cardiac structures. The recall is due to a failure mode where a glue bond on the Deployment Interlock Button has been observed to fail in the field.
The affected units are distributed worldwide, including in the United States (specifically Massachusetts, Alabama, North Carolina, and Oklahoma) and in Germany, France, and Great Britain. The recall covers specific lot numbers with expiry dates ranging from June 25, 2015, to September 24, 2015.
Healthcare providers and facilities should stop using the affected catheters and contact Boston Scientific for further instructions on the recall process.
The recalled product
- Product
- 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.
- Manufacturer
- Boston Scientific Corp
- Affected units
- 184
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (15)
- 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.
Distribution
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