Device Recall IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm)
Modèle / numéro de série
Catalog Number: PM4500N4; Material Number: M004PM45000N40; Serial numbers: 16521557, 16615976, 16623754, 16623755, 16736927, 16739588, 16743271, 16872124. Expiry Dates: May 11, 2014 to January 13, 2017
IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm); Asymmetric Curve. || The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures.
“We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm) Standard Curve. || The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures.
IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm); Large Curve. || The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures.