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U.S. Department of Health and Human Services

Class 2 Device Recall Pacific Xtreme (PTCA Balloon Dilation Catheter)

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  Class 2 Device Recall Pacific Xtreme (PTCA Balloon Dilation Catheter) see related information
Date Initiated by Firm August 26, 2020
Create Date September 30, 2020
Recall Status1 Terminated 3 on June 09, 2023
Recall Number Z-3055-2020
Recall Event ID 86393
510(K)Number K103464  
Product Classification Catheter, angioplasty, peripheral, transluminal - Product Code LIT
Product Pacific Xtreme (PTCA Balloon Dilation Catheter)
Code Information Model: PCU060150090 Lot Numbers: 217978890, 218622060.  Model: PCU060150130 Lot Numbers: 217466573, 217603335, 217790972, 217860448, 217876552, 217892598, 217951979, 218153799, 218217163, 218424513, 218482262, 218557813, 218639138, 218712737, 218732096, 218745770, 218815063, 218902560, 218998027, 219036544, 219105117, 219113539, 219236001, 219245043, 219369215, 219544768, 219690958.  Model Number: PCU060200090 Lot Number:217978889  Model Number: PCU060200130 Lot Numbers: 217371273, 217466571, 217617124, 217799993, 217876554, 217914347, 217951978,218037674, 218153802, 218247209, 218321788, 218502816, 218569122, 218655092, 218712742, 218723547, 218732101, 218745773, 218815056, 218846687, 218902556, 218994904, 219018137, 219097771, 219105115, 219113534, 219235998, 219245040, 219333058, 219369216, 219377669, 219444491, 219582240, 219598484, 219690961.  Model Number: PCU060250090 Lot Number: 217603333  Model Number: PCU060250130 Lot Numbers: 217371272, 217451265, 217741799, 217799997, 217867045, 217876555, 218153797, 218217158, 218239743, 218247216, 218424511, 218471575, 218502814, 218569123, 218732098, 218745771, 218815057, 218892319, 218994905, 219018141, 219036626, 219113533, 219235999, 219245041, 219290848, 219358711, 219444490, 219666731.  Model Number: PCU060300090 Lot Numbers: 217790974, 218179770.  Model Number: PCU060300130 Lot Numbers: 217466572, 217558443, 217693877, 217728143, 217741797, 217867826, 217892596, 217914351, 218033558, 218079623, 218170536, 218217164, 218247211, 218321790, 218454476, 218569121, 218655090, 218712741, 218723546, 218752665, 218815061, 218892317, 219018140, 219097767, 219105116, 219217703, 219235996, 219290780, 219369212, 219544769, 219582241, 219598482, 219666726.  Expiration dates are from 03/22/2022 to 04/21/2023
Recalling Firm/
Manufacturer		 ev3 Inc.
4600 Nathan Ln N
Plymouth MN 55442-2890
For Additional Information Contact Carlos Alfonzo
763-526-2513
Manufacturer Reason
for Recall		 Labeling discrepancy for the Rated Burst Pressure (RBP) value.
FDA Determined
Cause 2		 Under Investigation by firm
Action On August 26th 2020 the firm send its consignees a letter. Customer Instructions: Medtronic records indicate that your facility has received one or more of the listed Pacific Xtreme PTA Balloon Catheter. As a result, Medtronic requests that you immediately take the following actions: 1.Identify and quarantine all affected and unused Pacific Xtreme PTA Balloon Catheters as listed in the enclosed Customer Notification Detail Report. 2.Return/Exchange all affected and unused Pacific Xtreme PTA Balloon Catheters in your inventory to Medtronic.Contact Medtronic Customer Service at 800-716-6700 to initiate a product return/exchange. Your local Medtronic Representative can assist you as necessary in initiating the return of this product. 3.Complete the enclosed Customer Confirmation Form and email to rs.cfqfca@medtronic.com
Quantity in Commerce 4286 devices
Distribution Domestic Distribution: AL, AR, AZ, CA, CO, DC, DE, FL, GA, IA, IL,IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX,VA, WA, WI and WV. International Distribution: Canada and Puerto Rico.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LIT and Original Applicant = MEDTRONIC INC.
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