—#185850

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

FDA product code: NIM — Stent, Carotid
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P030047
Affected lot / code info: 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

Why it was recalled

Distal tip may become separated from the lumen wire in specific lots.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Cordis Corporation
Address: 14201 NW 60th Ave, Miami Lakes, Florida 33014-2802

Distribution

Distribution pattern: US (except MT and NM) and Taiwan

Timeline

Recall initiated: 2021-02-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #185850. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.