Cordis PRECISE PRO Rx Nitinol Stent System PC0730RXCRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705032036457), received between Mar 30, 2017 and Nov 24, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Crack” (1 report).

4 other recalls cover devices cleared under the same FDA submission (P030047); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 24, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE 7MM X 30MM PRECISE PRO RAPID EXCHANGE (RX) CAROTID STENT SYSTEM COULDN'T BE DELIVERED TO THE TARGET SITE THEN THE DOCTOR FOUND THE TIP WAS RIPPED AND FRAGMENTED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS OPENED IN STERILE FIELD. THE DEVICE WAS CONTAMINATED BUT WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10896624 ↗
• MalfunctionMar 30, 2017Crack; Crack

  DURING DEPLOYMENT OF THE PRECISE PRO RX US CAROTID SYSTEM STENT, THERE WAS SIGNIFICANT RESISTANCE AND THE STENT DELIVERY SYSTEM BROKE (THE DELIVERY SYSTEM CRACKED) WHILE ATTEMPTING TO APPROPRIATELY DELIVER THE STENT TO THE PROPER LOCATION. A DIFFERENT PRECISE PRO SYSTEM WAS USED TO COMPLETE THE PROCEDURE. DURING DEPLOYMENT THE PHYSICIAN FELT RESISTANCE AND THEN FELT NONE. THE STENT WAS NOT DEPLOYED BUT THE PART PINNED WAS AT THE ROTATING HEMOSTATIC VALVE (RHV). OUT AN ABUNDANCE OF CAUTION, THE PHYSICIAN REMOVED THE DEVICE AND DISCOVER THAT THE DELIVERY SYSTEM HAD BROKEN (CRACKED). THE PHYSICIAN TOOK A DIFFERENT PRECISE PRO CAROTID STENT AND COMPLETED THE CASE WITHOUT INCIDENT. THE PRODUCT WAS STORED, HANDLED, INSPECTED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS PREPPED APPROPRIATELY. THE PHYSICIAN IS FAMILIAR WITH THE DEVICE AND PERFORMED ALL PREP TASK APPROPRIATELY. THERE WASN'T ANYTHING UNUSUAL NOTED ABOUT THE STENT DELIVERY SYSTEM PRIOR TO USE. THE INTENDED PROCEDURE/TARGET LESION WAS THE CAROTID ARTERY, HOWEVER THE LESION CHARACTERISTICS ARE UNKNOWN. WHEN REMOVED FROM THE TRAY, THE STENT WAS STILL CONSTRAINED WITHIN THE OUTER MEMBER/SHEATH. THE FOLL

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6446843 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P030047. One submission often covers many models, so check the product and lot details in each record.

• Z-1257-2021 · Feb 11, 2021 · Completed
  PRECISE PRO RX CAROTID STENT implant system, Product Codes: PC0520RXC, PC0530RXC, PC0540RXC, PC0620RXC, PC0630RXC, PC0640RXC, PC0720RXC, PC0730RXC, PC0740RXC, PC0820RXC, PC0830RXC
• Z-0729-2020 · Nov 14, 2019 · Open, Classified
  Cordis Precise Nitinol Stent System. The Cordis PRECISE Nitinol Stent System devices are designed to deliver a flexible, self-expanding endoluminal stent to the carotid vascula
• Z-1947-2016 · May 4, 2016 · Terminated
  Cordis PRECISE (R) RX Nitinol Stent System (Biliary)
• Z-1946-2016 · May 4, 2016 · Terminated
  Cordis PRECISE (R) PRO RX Nitinol Stent System (Carotid)