PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System, Catalog numbers PG2990BPS, PG2990BPX, PG399
Summary
The FDA issued a Class II for PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System, Cat by Cordis US Corp. Reason: Potential for stent dislodgement and associated failures related to two specific sizes of the device..
Details
Source
Device Recall
External ID
Z-1363-2022
Action Date
2022-07-20
Status
Ongoing
Category
device
Product Description
PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System, Catalog numbers PG2990BPS, PG2990BPX, PG3990BPS, PG3990BPX.
Lot/Code Info: Catalog #PG2990BPS - Lot numbers 82184806, exp. 12/31/2022; 82191321, exp. 3/31/2023; and 82208532, exp. 10/31/2023. Catalog #PG2990BPX - Lot numbers 82185924, exp. 1/31/2023; and 82208528, exp. 10/31/2023. Catalog #PG3990BPS - Lot numbers 82180267, exp. 10/31/2022; 82191527, exp. 3/31/2023; 82193089, exp. 5/31/2023; and 82206059, exp. 10/31/2023. Catalog #PG3990BPX - Lot numbers 82208524, exp. 11/30/2023; and 82211296, exp. 12/31/2023.
Quantity Affected: 1,089 units
Reason for Recall
Potential for stent dislodgement and associated failures related to two specific sizes of the device.
Distribution
US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI, and WY. There was also government/military distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-05-20
Company
Miami Lakes, FL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 143 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Cordis US Corp has 26 FDA actions in our database, including 22 recalls and 4 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Cordis US Corp) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Cordis US Corp have FDA actions?
Cordis US Corp has 26 FDA actions in our database, including 22 recalls and 4 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1363-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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