Reported Oct 7, 2020 · Terminated
Pacific Xtreme (PTCA Balloon Dilation Catheter)
ev3 Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ev3 Inc. · 4600 Nathan Ln N · Plymouth, MN · 55442-2890
Is this the product you have?
- Pacific Xtreme (PTCA Balloon Dilation Catheter)
- Lot codes and dates
16 of 16 products
Products covered by this recall Model / number Product as published PCU060150090— — Lot Numbers: 217978890, 218622060. 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. PCU060200090— — Lot Number:217978889 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. PCU060250090— — Lot Number: 217603333 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. PCU060300090— — Lot Numbers: 217790974, 218179770. 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 - Amount recalled
- 4286 devices
Where it was sold
Why it was recalled
Labeling discrepancy for the Rated Burst Pressure (RBP) value.
This product could cause temporary or reversible health problems — stop using it.
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