Z-3055-2020Class II

Pacific Xtreme (PTCA Balloon Dilation Catheter)

Name: Z-3055-2020 Pacific Xtreme (PTCA Balloon Dilation Catheter)
Creator: ev3 Inc.
Published: 2020-08-26
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2020-08-26 / Terminated / root cause: labeling and UDI

FDA source

ev3 Inc. began a recall of Pacific Xtreme (PTCA Balloon Dilation Catheter) on 2020-08-26. FDA classified it as Class II and gives the reason as "Labeling discrepancy for the Rated Burst Pressure (RBP) value". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-3055-2020
Classification: Class II
Status: Terminated
Initiated: 2020-08-26
Posted: 2020-09-30
Terminated: 2023-06-09
Recalling firm: Medtronic, Inc.
Product: Pacific Xtreme (PTCA Balloon Dilation Catheter)
Product code: LIT Catheter, Angioplasty, Peripheral, Transluminal
Reason for recall: Labeling discrepancy for the Rated Burst Pressure (RBP) value.
Root cause tag: labeling and UDI
FDA 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 [email protected]
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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3055-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3055-2020	Class II	Terminated	Voluntary: Firm initiated	2020-10-07	2020-09-30

Product code LIT

K103464Class IIPacific Xtreme Ptca Balloon Dilatation CatheterMedtronic, Inc. / cleared 2010-12-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)