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U.S. Department of Health and Human Services

Class 1 Device Recall PRECISE PRO RX CAROTID STENT implant system

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  Class 1 Device Recall PRECISE PRO RX CAROTID STENT implant system see related information
Date Initiated by Firm February 11, 2021
Create Date March 15, 2021
Recall Status1 Open3, Classified
Recall Number Z-1257-2021
Recall Event ID 87329
PMA Number P030047 
Product Classification Stent, carotid - Product Code NIM
Product PRECISE PRO RX CAROTID STENT implant system, Product Codes: PC0520RXC, PC0530RXC, PC0540RXC, PC0620RXC, PC0630RXC, PC0640RXC, PC0720RXC, PC0730RXC, PC0740RXC, PC0820RXC, PC0830RXC, PC0840RXC, PC0920RXC, PC0930RXC, PC0940RXC, PC1030RXC, PC1040RXC
Code Information 1. PC0520RXC, Lot Numbers: 17917082, 17925698, 17945241, 17946961 2. PC0530RXC, Lot Numbers: 17907242, 17915157, 17931757, 17936915, 17940306, 17945490, 17950283, 17952939 3. PC0540RXC, Lot Numbers: 17907243, 17911879, 17920422, 17931758, 17942800, 17945242, 17947078, 17950284, 17955963, 17960311 4. PC0620RXC, Lot Numbers: 17917084, 17920423, 17931102, 17949017, 17955964 5. PC0630RXC, Lot Numbers: 17910548, 17914196, 17915158, 17921807, 17937805, 17939529, 17945243, 17945883, 17949018, 17957289  6. PC0640RXC, Lot Numbers: 17903563, 17908608, 17912281, 17916478, 17928282, 17934629, 17936243, 17939530, 17946675, 17950285, 17958864, 17961560  7. PC0720RXC, Lot Numbers: 17929124, 17933386 8. PC0730RXC, Lot Numbers: 17909814, 17916479, 17925699, 17929770, 17935168, 17940238, 17941419, 17949346, 17951255, 17951944, 17954156, 17959599  9. PC0740RXC, Lot Numbers: 17905295, 17915162, 17920425, 17922174, 17926320, 17935169, 17936920, 17937807, 17940240, 17941874, 17941875, 17956888, 17959601, 17962539  10. PC0820RXC, Lot Numbers: 17905297, 17919723, 17942803, 17945491 11. PC0830RXC, Lot Numbers: 17910553, 17916481, 17919724, 17928285, 17931762, 17934630, 17936244, 17939531, 17945884, 17945885, 17949962, 17955967, 17959602  12. PC0840RXC, Lot Numbers: 17904654, 17907246, 17910556, 17912285, 17913915, 17918979, 17918980, 17920427, 17921809, 17924451, 17926321, 17928286, 17929771, 17931763, 17933387, 17935170, 17936245, 17936922, 17936923, 17941421, 17941422, 17941876, 17941877, 17947267, 17947268, 17948772, 17949964, 17951256, 17958217, 17959603, 17961226 13. PC0920RXC, Lot Numbers: 17949965 14. PC0930RXC, Lot Numbers: 17906531, 17914902, 17929126, 17934632, 17941424, 17945244, 17946676, 17946963, 17960312  15. PC0940RXC, Lot Numbers: 17907250, 17912290, 17914198, 17916482, 17917085, 17919725, 17928287, 17931103, 17935173, 17936247, 17939532, 17940242, 17945886, 17950287, 17955668 16. PC1030RXC, Lot Numbers: 17911881, 17913484, 17918070, 17934633, 17940243, 17947080  17. PC1040RXC, Lot Numbers: 17913485, 17917086, 17917087, 17917088, 17920429, 17927599, 17929128, 17931104, 17934634, 17935176, 17936248, 17940244, 17940245 
Recalling Firm/
Manufacturer		 Cordis Corporation
14201 NW 60th Ave
Miami Lakes FL 33014-2802
For Additional Information Contact Cordis QA
786-313-2087
Manufacturer Reason
for Recall		 Distal tip may become separated from the lumen wire in specific lots.
FDA Determined
Cause 2		 Process control
Action The firm initiated the recall by letter on 02/11/2021. The letter explained the reason for recall and potential impact to the patient, along with the request to further disseminate the notices and return of the recalled units.
Quantity in Commerce 18218 units
Distribution US (except MT and NM) and Taiwan
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA Database PMAs with Product Code = NIM and Original Applicant = Cordis US Corporation
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