FDA Device recall Z-3055-2020

Pacific Xtreme (PTCA Balloon Dilation Catheter)

FDA Device
Class II
terminated
Published 2020-10-07

On 2020-10-07 the FDA classified a Class II recall of Pacific Xtreme (PTCA Balloon Dilation Catheter) by Ev3, citing labeling discrepancy for the Rated Burst Pressure (RBP) value.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-3055-2020
Classification	Class II
Status	terminated
Initiated	2020-08-26
Published	2020-10-07
Last updated	2026-09-13 11:55 UTC
Company	Ev3
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, PR, RI, SC, SD, TN, TX, VA, WA, WI, WV

Product

Pacific Xtreme (PTCA Balloon Dilation Catheter)

Reason

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

Identifiers

code_info	Model: PCU060150090 Lot Numbers: 217978890, 218622060. Model: PCU060150130 Lot Numbers: 217466573, 217603335, 2177… 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,

code_info

Model: PCU060150090 Lot Numbers: 217978890, 218622060. Model: PCU060150130 Lot Numbers: 217466573, 217603335, 2177…

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,

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3055-2020%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.