Home / Recalls / Boston Scientific Corp / Z-0463-2016

Z-0463-2016 Class II Terminated

Recalled by Boston Scientific Corp — San Jose, CA

FDA device recall Z-0463-2016 was initiated by Boston Scientific Corp on November 20, 2015 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated November 27, 2019). Affected quantity: 1556 total - all models.

Recall Details

Product Type
Devices
Report Date
December 30, 2015
Initiation Date
November 20, 2015
Termination Date
November 27, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1556 total - all models

Product Description

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, drug refractory atrial fibrillation.

Reason for Recall

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.

Distribution Pattern

Worldwide Distribution - US Nationwide in the state of: PA, FL, IN, MI, TN, AL, IL, KY, MI, TX, OH, MO, MA, MN, ID, AL, TN, VA, CA and internationally to Austria, Australia, Belgium, Switzerland, Germany, Great Britain, Greece, Hong Kong, Israel, Iran, Italy, Japan, Kuwait, Latvia, Malaysia, Netherlands, Saudi Arabia, Singapore, Thailand, and South Africa.

Code Information

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

Other recalls by Boston Scientific Corp

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  • Z-1730-2020 Class II — Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX /150CM UPN: M0066703061 (March 9, 2020)
  • Z-1737-2020 Class II — Stretch VL Ureteral Stent Set 4.8FX22-30CM with .035 Sensor UPN: M006185155080 (March 9, 2020)
  • Z-1738-2020 Class II — Stretch VL Ureteral Stent Set 6FX22- 30CM with .035 Sensor UPN: M006185156080 (March 9, 2020)
  • Z-1740-2020 Class II — Polaris Ultra Ureteral Stent Set 6FX24CM with .035 Sensor UPN: M006192132080 (March 9, 2020)
  • Z-1732-2020 Class II — Sensor Nitinol Wire with Hydrophilic Tip .0383CM FLEX ANG/150CM UPN: M006670 (March 9, 2020)
  • Z-1729-2020 Class II — Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX STR/150CM UPN: M00667030 (March 9, 2020)
  • Z-1731-2020 Class II — Sensor Nitinol Wire with Hydrophilic Tip .038 3CM FLEX STR/150CM UPN: M00667 (March 9, 2020)
  • Z-1739-2020 Class II — Stretch VL Ureteral Stent Set 7FX22-30CM with .035 Sensor UPN: M006185157080 (March 9, 2020)
  • Z-1733-2020 Class II — Percuflex Plus Ureteral Stent Set 6FX24CM with .038 Sensor UPN: M00617526211 (March 9, 2020)

FDA data resources