ev3 Inc.: Pacific Xtreme (PTCA Balloon Dilation Catheter)

Recall number

Z-3055-2020

Recalling firm

ev3 Inc.

Product

Pacific Xtreme (PTCA Balloon Dilation Catheter)

Status

Terminated

Initiated

2020-08-26

Posted

not on file

Terminated

2023-06-09

Reason

Labeling discrepancy for the Rated Burst Pressure (RBP) value.

Root cause

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

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.

Lot, serial or model codes

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

510(k) numbers

["K103464"]

PMA numbers

not on file

Product code

LIT

Firm FEI

2183870

Firm city

Plymouth

Firm state

MN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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