Pacific Xtreme (PTCA Balloon Dilation Catheter)
FDA Recall Z-3055-2020 · Posted None
Advertisement
Recalling Firmev3 Inc.
Recall StatusTerminated
Product CodeLIT
Date Initiated2020-08-26
Date Terminated2023-06-09
Product Quantity4286 devices
Reason for Recall
Labeling discrepancy for the Rated Burst Pressure (RBP) value.
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]
Root Cause
Under Investigation by firm
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement