DELTAPLUSH CERECYTE CPL100203-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00878528008200), received between Sep 19, 2016 and Apr 23, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2018Fracture; Kinked; Fracture; Kinked

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7451746 ↗
• MalfunctionDec 15, 2016Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, THE INTRODUCER SHEATH OF THE DELTAPLUSH 10 (CPL10020330/ S10167) WAS ALREADY DAMAGED (TORN/RUPTURED) IN THE PACKAGING, AND PRODUCT ANALYSIS ON (B)(6) 2016 FOUND THAT THE COIL HAD COMPRESSION AND BUCKLING DAMAGE AT THE PROXIMAL END. THE PACKAGING DID NOT APPEAR DAMAGED AND THE DEVICE WAS SECURELY PACKAGED. IT WAS REPORTED THAT THE DEVICE WOULD BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6176540 ↗
• MalfunctionSep 19, 2016Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  AS REPORTED BY A HEALTH CARE PROFESSIONAL, RESISTANCE WAS EXPERIENCED WITH GALAXY COIL AND A DELTAPLUSH (CPL10020330/C33965) COIL. THE GALAXY COIL WAS USED AFTER THREE COILS WERE EMBOLIZED, THE COIL GOT STUCK AT THE MIDDLE AREA OF THE MICROCATHETER. THE COIL WAS RE-SHEATHED, RETRIEVED AND CLEANED UPON RETRIEVAL. THE PHYSICIAN THEN CLEANED THE INSIDE OF THE MICROCATHETER AND TRIED REUSING THE GALAXY COIL. THE COIL WAS STUCK IN THE SHEATH AND COULD NOT BE DELIVERED. THE SAME EVENT OCCURRED WITH THE DELTAPLUSH (CPL10020330/C33965) COIL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 10-MINUTE DELAY. THE PROCEDURE WAS PARTIAL EMBOLIZATION OF THE SPLENIC ARTERY. THE PATIENT WAS A MALE OF UNKNOWN AGE; THE VESSELS WERE MODERATELY TORTUOUSNESS AND WERE NOT CALCIFIED. THERE WERE NO PATIENT INJURIES OR COMPLICATIONS REPORTED. THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND A CONSTANT FLUSH WAS MAINTAINED AT ALL TIMES. NO VISIBLE DEFECT/DAMAGE WAS NOTED ON THE PRODUCTS PRIOR TO AND AFTER THE EVENT. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. THE PRODUCT WILL BE RETURNED FOR THE INV

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5959475 ↗

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