Reported Mar 11, 2015 · Terminated
IntellaTip MiFi Open-Irrigated radiofrequency Ablation Catheters
Boston Scientific Corp.
High riskUsing this product could cause serious injury, illness or death — stop using it now.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?
IntellaTip MiFi Open-Irrigated radiofrequency Ablation Catheters
3 of 3 products
| Model / number | Product as published |
|---|---|
EPM9620K2 | Material number: M004EPM96200, Catalog Number: EPM9620: Material number: M004EPM9620K20 |
| — | Material number : M004EPM9620N40 |
EPM9620N4. | The IntellaTip MiFi Open-Irrigated Ablation Catheter is a 7.5F (2.5 mm) quadrapolar open-irrigated (OI) ablation catheter designed to deliver radiofrequency (RF) energy to the 4.5 mm catheter tip electrode for cardiac ablation The product is not approved for use/sale in the US. |
- Lot codes and dates
4 of 4 products
Products covered by this recall Model / number Product as published EPM9620Material number: M004EPM96200 EPM9620K2Serial numbers: 16941576, 16943730, 17150129, 17156568, 17156570, 17168752, 17171230, 17218387, 17221754, 17237747, 17247469, 17261879. Material number: M004EPM9620K20, : Serial numbers : 17018928, 17018929, 17147617, 17172602, 17175351, 17223957, 17230227, 17233882, 17235011, 17241926, 17263604, 17285884, 17288714. Material number : M004EPM9620N40 EPM9620N4— — Serial numbers: 17148152, 17226126, 17266642. All with Expiry Dates of April 20, 2015 - June 14, 2015. - Amount recalled
- 14 units
Why it was recalled
Stop using this product now
Reports of formation of char adherent to the proximal part of the distal tip electrodes
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Boston Scientific Corp. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.