Boston Scientific Recalls IntellaTip MiFi Radiofrequency Ablation Catheters
Boston Scientific is recalling 14 IntellaTip MiFi radiofrequency ablation catheters due to reports of char formation on the distal tip electrodes.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is Class I, which mandates a minimum severity score of 4 per the rubric.
Plain-English summary
Boston Scientific Corp is recalling 14 units of IntellaTip MiFi Open-Irrigated radiofrequency Ablation Catheters. The affected devices include specific material and catalog numbers (M004EPM96200/EPM9620, M004EPM9620K20/EPM9620K2, and M004EPM9620N40/EPM9620N4) with expiry dates ranging from April 20, 2015, to June 14, 2015.
The recall was initiated due to reports of char formation adherent to the proximal part of the distal tip electrodes. The product is a 7.5F quadrapolar open-irrigated ablation catheter designed to deliver radiofrequency energy for cardiac ablation. The source text notes that the product is not approved for use or sale in the US.
The devices were distributed in Germany, Great Britain, and the Netherlands. Specific serial numbers for the affected units are listed in the recall documentation. Users should stop using the affected devices and contact the manufacturer for further instructions.
The recalled product
- Product
- IntellaTip MiFi Open-Irrigated radiofrequency Ablation Catheters: Material number: M004EPM96200, Catalog Number: EPM9620: Material number: M004EPM9620K20, Catalog Number: EPM9620K2; Material number : M004EPM9620N40; Catalog number: EPM9620N4. The IntellaTip MiFi…
- Manufacturer
- Boston Scientific Corp
- Hazard
- Affected units
- 14
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 (20)
- Material number: M004EPM96200
- Catalog Number EPM9620
- Serial numbers: 16941576
- 16943730
- 17150129
- 17156568
- 17156570
- 17168752
- 17171230
- 17218387
- 17221754
- 17237747
- 17247469
- 17261879. Material number: M004EPM9620K20
- Catalog Number: EPM9620K2: Serial numbers : 17018928
- 17018929
- 17147617
- 17172602
- 17175351
- 17223957
Distribution
Distribution scope not specified by the agency.
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