DELTAPLUSH CERECYTE CPL100204-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00878528008224), received between Dec 15, 2016 and Jan 14, 2019 — classified as 5 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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 14, 2019Material Twisted/Bent; Material Twisted/Bent

  A REPORT WAS RECEIVED THAT DURING A COIL EMBOLIZATION, THE 2MM X 4CM DELTAPLUSH 10 (CPL10020430/C24954) AND 2MM X 6CM DELTAPLUSH 10 (CPL10020630/L10055) COILS WERE NOTED TO BE KINKED AND COULD NOT BE DEPLOYED/INSERTED INTO THE EMBOLIZATION. THE COILS WERE REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT WAS NOT REPORTED IF THE COILS WERE REMOVED WITHOUT THE NEED FOR ADDITIONAL INTERVENTION. THE SURGERY WAS NOT DELAYED DUE TO THE EVENT. THERE WAS NO REPORT OF CONSEQUENCE OF IMPACT TO THE PATIENT. THE PRODUCTS WILL BE RETURNED FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8245809 ↗
• MalfunctionOct 2, 2017Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, A DELTAPLUSH COIL (CPL10020430/C40204) STRETCHED DURING THE PROCEDURE. THEY USED ANOTHER ONE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY. IT WAS REPORTED THAT THE DEVICE WOULD BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6907495 ↗
• MalfunctionOct 2, 2017Positioning Failure; Positioning Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, A DELTAPLUSH COIL (CPL10020430/C38767) COULD NOT BE DETACHED DURING THE PROCEDURE. THEY USED ANOTHER ONE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY. IT WAS REPORTED THAT THE DEVICE WOULD BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6906965 ↗
• MalfunctionSep 11, 2017Kinked; Kinked

  AS REPORTED BY A HEALTH CARE PROFESSIONAL, DURING COILING OF AN ANTERIOR COMMUNICATING ARTERY ANEURYSM A DELTAPLUSH CERECYTE 2 MM X 4 CM (CPL10020430/C38154) DID NOT ADVANCE THROUGH THE PROXIMAL SHAFT OF A COMPETITOR¿S MICROCATHETER (ECHELON14 45-DEGREE MC). THE PROCEDURE WAS CONTINUED USING A SAME LIKE PRODUCT AND A DELAY OF 5 MINUTES WAS REPORTED DUE TO THE PRODUCT ISSUE. A DELTAPLUSH AND MICRUSPHERE COIL WENT THROUGH THE SAME MC WITHOUT ISSUES BEFORE AND AFTER THE ENCOUNTERED RESISTANCE. THERE WERE NO ISSUES EXPERIENCED WITH THE ECHELON MC. THERE WERE NO DAMAGES REPORTED ON THE COIL OR THE MC PRIOR TO USE OR UPON REMOVAL. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE CATHETER. THERE WERE NO ADVERSE CONSEQUENCES DUE TO THE REPORTED EVENT. IT WAS INITIALLY REPORTED THAT THE COMPLAINT PRODUCT IS AVAILABLE FOR RETURN, HOWEVER THE MC IS NOT AVAILABLE FOR RETURN. THE DELTAPLUSH EMBOLIC COIL WAS FOUND TO BE KINKED WHEN RECEIVED FOR INVESTIGATION. IT IS UNKNOWN WHEN THE DAMAGE TO THE COIL OCCURRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6854294 ↗
• MalfunctionDec 15, 2016Positioning Failure; Positioning Failure

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT A DELTAPL CERE COIL 10 SYS 2X4 WAS USED DURING A PROCEDURE AND WHEN THE DEVICE WAS GOING TO BE INTRODUCED INTO THE PATIENT, THE PLASTIC COULD NOT BE REMOVED AND THEREFORE THE COIL COULD NOT BE DEPLOYED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6178206 ↗

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