openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 6
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.
Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification.
Code information
Catalog Number: PM4500; Material Number: M004PM45000; Serial numbers: 16521554, 16538010, 16573561, 16615973, 16744972, 16744973, 16744974, 16744975, 16872127, 16872836. Expiry Dates: May 7, 2014 to January 13, 2017
Distribution pattern
Nationwide Distribution.
device · product 2 of 6
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.
Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification.
Code information
Catalog Number: PM4500K2; Material Number: M004PM45000K20; Serial numbers: 16560406, 16560408, 16573562, 16573563, 16573564, 16599366, 16606148, 16615974, 16615975, 16623756, 16743274, 16743275, 16743276, 16757632, 16757633, 16757634, 16757635, 16757636, 16757637, 16757638, 16757639, 16757781, 16757782, 16872835. Expiry Dates: May 11, 2014 to January 13, 2017
Distribution pattern
Nationwide Distribution.
device · product 3 of 6
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.
Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification.
Code information
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
Distribution pattern
Nationwide Distribution.
device · product 4 of 6
IntellaTip MiFi XP Temperature Ablation Catheter; 10m 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.
Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification.
Code information
Catalog Number: PM4790; Material Number: M004PM47900; Serial numbers: 16538009, 16743272, 16743273, 16872937 Expiry Dates: May 11, 2014 to January 13, 2017
Distribution pattern
Nationwide Distribution.
device · product 5 of 6
IntellaTip MiFi XP Temperature Ablation Catheter; 10m 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.
Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification.
Code information
Catalog Number: PM4790K2; Material Number: M004PM47900K2; Serial numbers: 16739673, 16739674, 16739675, 16739676, 16739677, 16739678, 16739679, 16739860, 16872121, 16872935 Expiry Dates: May 11, 2014 to January 13, 2017
Distribution pattern
Nationwide Distribution.
device · product 6 of 6
IntellaTip MiFi XP Temperature Ablation Catheter; 10m 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.
