CASHMERE CERECYTE CRC140512-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00878528004523), received between Sep 27, 2016 and Dec 14, 2017 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 14, 2017Unraveled Material; Unraveled Material

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT A C-CASHMERE (CRC14051230/C19487) WAS USED DURING A COIL EMBOLIZATION PROCEDURE FOR AN EMERGENCY EVER AT THE LEFT INTERNAL ILIAC ARTERY WHERE THE COIL UNRAVELED. THE PHYSICIAN FELT SOMETHING THAT SEEMED TO BE UNRAVELED IN THE MICROCATHETER WHILE EMBOLIZATION WAS PERFORMED. THE COIL WAS REMOVED COMPLETELY AND WAS REPLACED WITH ANOTHER ONE. THE PATIENT WAS A MALE, AGE UNKNOWN, WHOSE VESSEL WAS HEAVILY TORTUROUS AND MODERATELY CALCIFIED. A GUIDEWIRE (CHIKAI, ASAHI INTECC), A MICROCATHETER (PROWLER SELECT PLUS LPES), A Y CONNECTOR (OKAY, GOODMAN), AN ENPOWER CABLE, AND DCB000005-00 WERE ALSO USED FOR THIS PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY. THERE WAS ALSO NO PATIENT INJURY/COMPLICATION REPORTED. THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND THE CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIME. NO VISIBLE DEFECT/DAMAGE WAS NOTED ON THE PRODUCTS PRIOR TO THE EVENT. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. THE PRODUCT IS NOT AVAILABLE FOR THE INVESTIGATION. NO FURTHER INFORMATIO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7117443 ↗
• MalfunctionAug 7, 2017Failure to Advance; Failure to Advance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL DURING THE PROCEDURE, RESISTANCE WAS EXPERIENCED WHEN A PRESIDIO10 COIL (PC410073030/C23504) AND A CASHMERE COIL (CRC14051230/S11722) WERE ADVANCED THROUGH A PROWLER CATHETER (606S155FX/17574497). INTRODUCER SHEATH OF BOTH THE PRESIDIO10 COIL AND THE CASHMERE COIL WERE ALSO DAMAGED. THE PROCEDURE WAS PRE-ENDOVASCULAR ANEURYSM REPAIR COIL EMBOLIZATION AT BRANCH(ES) OF THE LEFT INTERNAL ILIAC ARTERY. THE PATIENT WAS A (B)(6) MALE. THE PATIENT¿S VESSEL WAS HEAVILY TORTUROUS AND HEAVILY CALCIFIED. THE PRESIDIO10 COIL WAS DELIVERED HOWEVER RESISTANCE WAS EXPERIENCED WITH THE PROWLER CATHETER. REPORTEDLY THE DIAMETER OF THE PROWLER SELECT LPES WAS SMALL. THE INTRODUCER SHEATH OF THE PRESIDIO 10 COIL GOT DAMAGED DURING FRAMING. THEREFORE, IT WAS REPLACED WITH A CASHMERE COIL (CRC14051230/S11722), BUT THE SHEATH GOT DAMAGED AS WELL. THEREFORE, THE MICRO CATHETER WAS REPLACED WITH OTHER MICROCATHETER (SELECT PLUS), AND A NEW COIL WAS DELIVERED (PRESIDIO8*30). THE PROCEDURE WAS COMPLETED USING MICRUS COIL(S). EXCESSIVE FORCE WAS NOT USED WHEN HANDLING THE COMPLAINT COILS AND NO DIFFICULTY WAS EXPERIENCED WHEN HANDLING THE TWO COMPLAINT COILS. THE PROC

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6771629 ↗
• MalfunctionSep 27, 2016Positioning Failure; Positioning Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COIL EMBOLIZATION PROCEDURE OF RIGHT ANTERIOR CHOROIDAL ARTERY ANEURYSM A CASH 14 CERE 5MMX12CM ((B)(4)) COULD NOT BE DETACHED. A PRE-DEPLOYMENT CHECK WAS PERFORMED. THERE WERE NO DAMAGES NOTED ON THE COIL PRIOR TO USE OR UPON REMOVAL. THE COMPLAINT COIL WAS WITHDRAWN AND A NEW COIL (TYPE/LOT UNKNOWN) WAS USED TO COMPLETE THE PROCEDURE. THE REPORTED EVENT DID NOT REQUIRE AN EXCHANGE OF THE CONNECTING CABLE OR THE DETACHMENT CONTROL BOX, THE SAME CABLE AND DCB WERE USED FOR COILS PRIOR TO AND AFTER THE REPORTED EVENT. THE PATIENT WAS A (B)(6) FEMALE WITH AN ANEURYSM OF SIZE (B)(6). THERE WAS NO REPORT ON THE PATIENT INJURY. THERE WERE NO INTRA OR POST PROCEDURAL COMPLICATIONS OR DELAYS RELATED TO DEVICE OR REPORTED EVENT. IT WAS INITIALLY REPORTED THAT THE COMPLAINT PRODUCT IS AVAILABLE FOR RETURN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5980333 ↗