Z-1257-2021Class I

PRECISE PRO RX CAROTID STENT implant system, Product Codes: PC0520RXC, PC0530RXC, PC0540RXC, PC0620RXC...

Name: Z-1257-2021 PRECISE PRO RX CAROTID STENT implant system, Product Codes: PC0520RXC, PC0530RXC, PC0540RXC, PC0620RXC...
Creator: Cordis Corporation
Published: 2021-02-11
License: https://open.fda.gov/license/

Cordis US Corp. / initiated 2021-02-11 / Completed / root cause: manufacturing process

FDA source

Cordis Corporation began a recall of PRECISE PRO RX CAROTID STENT implant system, Product Codes: PC0520RXC, PC0530RXC, PC0540RXC, PC0620RXC, PC0630RXC, PC0640RXC, PC0720RXC, PC0730RXC, PC0740RXC... on 2021-02-11. FDA classified it as Class I and gives the reason as "Distal tip may become separated from the lumen wire in specific lots". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1257-2021
Classification: Class I
Status: Completed
Initiated: 2021-02-11
Posted: 2021-03-15
Recalling firm: Cordis US Corp.
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
Product code: NIM Stent, Carotid
Reason for recall: Distal tip may become separated from the lumen wire in specific lots.
Root cause tag: manufacturing process
FDA root cause: 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1257-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1257-2021	Class I	Completed	Voluntary: Firm initiated	2021-03-24	2021-03-15

Product code NIM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)