IntellaTip MiFi XP Temperature Ablation Catheter recall
IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Standard Curve. The BSC Controller and Accessories are indicated for use in…
Why was IntellaTip MiFi XP Temperature Ablation Catheter recalled?
Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification.
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?
Catalog Number: PM4790; Material Number: M004PM47900; Serial numbers: 16538009, 16743272, 16743273, 16872937 Expiry Dates: May 11, 2014 to January 13, 2017
- Product
- IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Standard Curve. The BSC Controller and Accessories are indicated for use in…
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 968 units total all models
- Distribution
- Nationwide Distribution.
- Recall date
- June 25, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)