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Cordis Vista Brite Tip & Androit Guiding Catheters Product Usage: The guiding catheter is int...

FDA Device Recall #Z-1198-2019 — Class III — February 7, 2019

Recall Summary

Recall Number Z-1198-2019
Classification Class III — Low risk
Date Initiated February 7, 2019
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Cordis Corporation
Location Miami Lakes, FL
Product Type Devices
Quantity 23481

Product Description

Cordis Vista Brite Tip & Androit Guiding Catheters Product Usage: The guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vascular systems.

Reason for Recall

Frayed pieces of the mounting card being inside the primary packaging.

Distribution Pattern

Worldwide Distribution - US Nationwide in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico and Guam Singapore and Canada

Lot / Code Information

Lot Number Exp. Date 17744955 12/31/2020 17750783 12/31/2020 17757121 1/31/2021 17735533 10/31/2020 17735534 10/31/2020 17744429 12/31/2020 17744430 12/31/2020 17750785 12/31/2020 17757116 1/31/2021 17748743 12/31/2020 17750476 12/31/2020 17755096 1/31/2021 17757122 1/31/2021 17753002 12/31/2020 17779364 4/30/2021 17815946 9/30/2021 17805148 7/31/2021 17815949 9/30/2021 17753959 1/31/2021 17746022 12/31/2020 17762925 2/28/2021 17733016 10/31/2020 17747583 12/31/2020 17749800 12/31/2020 17752698 12/31/2020 17767925 2/28/2021 17769354 3/31/2021 17771053 3/31/2021 17772929 4/30/2021 17722360 9/30/2020 17735189 10/31/2020 17733019 10/31/2020 17746026 12/31/2020 17747584 12/31/2020 17749793 12/31/2020 17752703 12/31/2020 17754875 1/31/2021 17756762 1/31/2021 17762928 2/28/2021 17771058 3/31/2021 17772931 4/30/2021 17816029 9/30/2021 17817637 9/30/2021 17722359 9/30/2020 17740611 11/30/2020 17778655 4/30/2021 17724480 9/30/2020 17767923 2/28/2021 17771049 3/31/2021 17772926 4/30/2021 17756076 7/31/2020 17816499 3/31/2021 17753948 7/31/2020 17777712 10/31/2020 17816501 3/31/2021 17729208 3/31/2020 17733005 4/30/2020 17736643 4/30/2020 17737608 4/30/2020 17740605 5/31/2020 17742559 5/30/2020 17743099 6/30/2020 17743101 6/30/2020 17745965 6/30/2020 17756074 7/31/2020 17816500 3/31/2021 17756075 7/31/2020 17746147 12/31/2020 17807995 8/31/2021 17811028 8/31/2021 17814511 9/30/2021 17818155 9/30/2021 17755015 1/31/2021 17724819 9/30/2020 17742581 11/30/2020 17756975 1/31/2021 17771328 3/31/2021 17794750 6/30/2021 17814264 9/30/2021 17816167 9/30/2021 17750494 12/31/2020 17817649 9/30/2021 17800760 7/31/2021 17801566 7/31/2021 17802170 7/31/2021 17802171 7/31/2021 17803141 7/31/2021 17803142 7/31/2021 17803143 7/31/2021 17803536 7/31/2021 17803539 7/31/2021 17803540 7/31/2021 17804225 7/31/2021 17804226 7/31/2021 17804764 7/31/2021 17805447 7/31/2021 17805899 8/31/2021 17805901 8/31/2021 17806219 8/31/2021 17806330 8/31/2021 17806331 8/31/2021 17806332 8/31/2021 17806706 8/31/2021 17807595 8/31/2021 17807603 8/31/2021 17807626 8/31/2021 17807628 8/31/2021 17807629 8/31/2021 17809536 8/31/2021 17809537 8/31/2021 17809538 8/31/2021 17809786 8/31/2021 17809791 8/31/2021 17809792 8/31/2021 17809793 8/31/2021 17810429 8/31/2021 17810430 8/31/2021 17810432 8/31/2021 17810433 8/31/2021 17811219 8/31/2021 17811220 8/31/2021 17811221 8/31/2021 17811677 8/31/2021 17811834 8/31/2021 17811836 8/31/2021 17811837 8/31/2021 17811839 8/31/2021 17812321 8/31/2021 17813158 9/30/2021 17813159 9/30/2021 17814278 9/30/2021 17814279 9/30/2021 17814640 9/30/2021 17814641 9/30/2021 17814642 9/30/2021 17814643 9/30/2021 17815025 9/30/2021 17815340 9/30/2021 17817001 9/30/2021 17817002 9/30/2021 17817004 9/30/2021 17817285 9/30/2021 17818563 9/30/2021 17818564 9/30/2021 17819221 9/30/2021 17819222 9/30/2021 17821534 10/31/2021 17800613 7/31/2021 17800614 7/31/2021 17800615 7/31/2021 17802172 7/31/2021 17803537 7/31/2021 17803538 7/31/2021 17804026 7/31/2021 17804222 7/31/2021 17804223 7/31/2021 17804224 7/31/2021 17804765 7/31/2021 17804766 7/31/2021 17805898 7/31/2021 17805900 8/31/2021 17805902 8/31/2021 17806214 8/31/2021 17807627 8/31/2021 17808004 8/31/2021 17809486 8/31/2021 17811835 8/31/2021 17815021 9/30/2021 17815022 9/30/2021 17815023 9/30/2021 17815024 9/30/2021 17817003 9/30/2021 17819220 9/30/2021

Other Recalls from Cordis Corporation

Recall # Classification Product Date
Z-0221-2022 Class II SMART FLEX 10x100 BIL, 120cm The S.M.A.R.T.¿ F... Oct 1, 2021
Z-0216-2022 Class II SMART FLEX 9x60 BIL, 80cm The S.M.A.R.T.¿ Flex... Oct 1, 2021
Z-0218-2022 Class II SMART FLEX 6x150 BIL, 120cm The S.M.A.R.T.¿ Fl... Oct 1, 2021
Z-0220-2022 Class II SMART FLEX 10x100 BIL, 80cm The S.M.A.R.T.¿ Fl... Oct 1, 2021
Z-0219-2022 Class II SMART FLEX 8x60 BIL, 80cm The S.M.A.R.T.¿ Flex... Oct 1, 2021

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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