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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Boston Scientific Corp: During routine monitoring of complaints, BSC noted that the IntellaTip MiFi XP N4 complaint rate for distal tip bends/kinks was above the anticipated rate in BSC's product risk documentation.; During routine monitoring of complaints, BSC noted that the IntellaTip MiFi XP N4 complaint rate for distal tip bends/kinks was above the anticipated rate in BSCs product risk documentation.

Agency Publication Date: December 22, 2015
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Affected Products

Product: IntellaTip MiFi XP Asymmetric (N4) Curve, 7/110/2.5/8-8 OUS; Material Number: M004EPM4500N40; Catalog number: EPM4500N4; Cardiac: The IntellaTip MiFi XP Catheter is indicated for interruption of accessory atrioventricular conduction pathways associated with tachycardia, for treatment of AV nodal reentrant tachycardia, for treatment of atrial flutter tachycardia, and for creation of complete AV block in patients with a rapid ventricular response to an atrial arrhythmia  typically chronic

Material Number: M004EPM4500N40; Catalog number: EPM4500N4; Lot numbers: 16743760, 17135083, 17614450, 18140623, 18162387. Expiration Date Range: 2/16/2017 to 7/3/2018.

Lot Numbers:
numbers
Product: IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-10 OUS; Material Number: M004EPM4790N40; Catalog number: EPM4790N4; Cardiac: The IntellaTip MiFi XP Catheter is indicated for interruption of accessory atrioventricular conduction pathways associated with tachycardia, for treatment of AV nodal reentrant tachycardia, for treatment of atrial flutter tachycardia, and for creation of complete AV block in patients with a rapid ventricular response to an atrial arrhythmia typically chronic,

Material Number: M004EPM4790N40; Catalog number: EPM4790N4; Lot numbers: 16743398, 17135082.. Expiration Date Range: 2/16/2017 to 7/22/2017

Lot Numbers:
numbers
Product: IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-8 Material Number: M004PM4500N40; Catalog number: PM4500N4; Cardiac: The IntellaTip MiFi XP Catheter is indicated for interruption of accessory atrioventricular conduction pathways associated with tachycardia, for treatment of AV nodal reentrant tachycardia, for treatment of atrial flutter tachycardia, and for creation of complete AV block in patients with a rapid ventricular response to an atrial arrhythmia typically chronic, drug re

Material Number: M004PM4500N40; Catalog number: PM4500N4; Lot numbers: 16309584, 16615976, 16623754, 16623755, 16722434, 16736927, 16739588, 16743271, 16872124, 16999075, 17118111, 17157418, 17201805, 17222051, 17222052, 17370483, 17376573, 17376574, 17436562, 17436563, 17436565, 17451802, 17478950, 17499145, 17499152, 17590503, 17611785, 17625992, 17768306, 17791420, 17925492, 17925493, 18012208, 18161715. Expiration Date Range:8/15/2016 to 7/2/2018.

Lot Numbers:
numbers
Product: IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-10 ; Material Number: M004PM4790N40; Catalog number: PM4790N4; Cardiac: The IntellaTip MiFi XP Catheter is indicated for interruption of accessory atrioventricular conduction pathways associated with tachycardia, for treatment of AV nodal reentrant tachycardia, for treatment of atrial flutter tachycardia, and for creation of complete AV block in patients with a rapid ventricular response to an atrial arrhythmia  typically chronic, dru

Material Number: M004PM4790N40; Catalog number: PM4790N4; Lot numbers: 16743269, 16818653, 16818654, 16872007, 16993525, 17511087, 18159904, 18385792. Expiration Date Range: 9/1/2016 to 9/20/2018. .

Lot Numbers:
numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 72721
Status: Resolved
Manufacturer: Boston Scientific Corp
Manufactured In: United States
Units Affected: 4 products (1556 - all models; 1556 total - all models; 1556 total - all models; 1556 total - all models)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.