DELTAPLUSH CERECYTE CPL100202-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00878528008217), received between Aug 30, 2016 and Aug 30, 2016 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K083646); 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 16, 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.

• MalfunctionAug 30, 2016Positioning Failure; Positioning Failure

  AS REPORTED BY A HEALTH CARE PROFESSIONAL, DURING AN EMERGENCY COIL EMBOLIZATION OF AN ANEURYSM FOR HEMOPTYSIS TWO DELTAPLUSH (CPL100202-30/C36701) COILS FAILED TO DETACH. THE PATIENT'S GENDER AND AGE WERE UNKNOWN; THE LEVEL OF TORTUOUSNESS AND CALCIFICATION OF THE VESSELS WERE ALSO UNKNOWN. A 4FR SYSTEM WITH 45 DEGREE MICROCATHETER (COMPETITOR'S) WAS USED FOR THE PROCEDURE. A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED INDICATING NO ISSUES WITH THE POWER SUPPLY. WHEN THE PHYSICIAN ATTEMPTED TO DETACH THE COMPLAINT DELTAPLUSH COILS AFTER PLACEMENT, THE AUDIBLE SIGNAL BEEPED HOWEVER THE COILS DID NOT DETACH. THE COILS WERE COLLECTED AS DEFECTIVE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES AND DELAY. THERE WERE NO PATIENT INJURIES OR COMPLICATIONS REPORTED. ALL CONNECTIONS APPEAR TO FIT PROPERLY WITHOUT APPLICATION OF EXCESSIVE FORCE. THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND A CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIMES. NO VISIBLE DEFECT OR DAMAGE WAS NOTED ON THE PRODUCTS PRIOR TO AND AFTER THE EVENT. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICROCAT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5913470 ↗
• MalfunctionAug 30, 2016Positioning Failure; Positioning Failure

  AS REPORTED BY A HEALTH CARE PROFESSIONAL, DURING AN EMERGENCY COIL EMBOLIZATION OF AN ANEURYSM FOR HEMOPTYSIS TWO DELTAPLUSH (CPL100202-30/C36701) COILS FAILED TO DETACH. THE PATIENT'S GENDER AND AGE WERE UNKNOWN; THE LEVEL OF TORTUOUSNESS AND CALCIFICATION OF THE VESSELS WERE ALSO UNKNOWN. A 4FR SYSTEM WITH 45 DEGREE MICROCATHETER (COMPETITOR'S) WAS USED FOR THE PROCEDURE. A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED INDICATING NO ISSUES WITH THE POWER SUPPLY. WHEN THE PHYSICIAN ATTEMPTED TO DETACH THE COMPLAINT DELTAPLUSH COILS AFTER PLACEMENT, THE AUDIBLE SIGNAL BEEPED HOWEVER THE COILS DID NOT DETACH. THE COILS WERE COLLECTED AS DEFECTIVE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES AND DELAY. THERE WERE NO PATIENT INJURIES OR COMPLICATIONS REPORTED. ALL CONNECTIONS APPEAR TO FIT PROPERLY WITHOUT APPLICATION OF EXCESSIVE FORCE. THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND A CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIMES. NO VISIBLE DEFECT OR DAMAGE WAS NOTED ON THE PRODUCTS PRIOR TO AND AFTER THE EVENT. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICROCAT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5913466 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083646. One submission often covers many models, so check the product and lot details in each record.

• Z-0845-2011 · Oct 21, 2010 · Terminated
  Micrus Endovascular Microcoil Delivery System; The Micrus Microcoil Delivery System consists of three components, a Microcoil System, a Connecting Cable, and a Detachment Control B