DELTAPLUSH CERECYTE CPL100152-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00878528008170), received between Feb 10, 2017 and Dec 16, 2019 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 16, 2019Material Deformation; Material Deformation

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION A 1.5X2 DELTAPL CERE COIL 10 SYS (CPL10015230, S14634) COULD NOT BE ADVANCED NOR RETRIEVED BY THE PHYSICIAN. THERE WAS NO PATIENT INJURY REPORTED. THE COMPLAINT DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE AND THE PATIENT OUTCOME WAS ¿GOOD¿. THE COIL WAS BEING USED AS THE LAST COIL (5TH). ADEQUATE AND CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE CATHETER. WHEN THE COIL WAS REMOVED FROM THE PATIENT, THERE WAS NO DAMAGES ON ACTUAL COIL OR OTHER PARTS OF THE DEVICE. ONLY DAMAGE WAS TO THE SHEATH INTRODUCER. THE SAME MICROCATHETER WAS USED TO COMPLETE THE PROCEDURE. PICTURES WERE RECEIVED. BASED ON THE DEVICE ANALYSIS, THE EMBOLIC COIL WAS DAMAGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9475532 ↗
• MalfunctionJul 22, 2019Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION, THE 1.5MM X 2CM DELTAPLUSH 10 CERECYTE COIL (CPL10015230 / S13546) COULD NOT BE DETACHED. THE COIL WAS WITHDRAWN, AND ANOTHER COIL WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATION. IT WAS REPORTED THAT THE PRODUCT IS AVAILABLE TO BE RETURNED FOR EVALUATION AND ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8812559 ↗
• MalfunctionOct 2, 2018Material Separation; Stretched; Material Deformation; Material Separation; Stretched; Material Deformation

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION PROCEDURE, THE 1.5MM X 2CM DELTAPLUSH CERE 10 (CPL10015230/S10766) THERMO-MECHANICAL COIL COULD NOT BE ADVANCED OUT OF THE UNSPECIFIED MICROCATHETER. THE COIL WAS REMOVED FROM THE MICROCATHETER AND REPLACED. THE SAME MICROCATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF A LOSS OF CEREBRAL TARGET POSITION. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. NO VISIBLE PRODUCT DAMAGE WAS NOTED PRIOR TO THE EVENT OR AFTER REMOVAL FROM THE PATIENT. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. EVALUATION OF THE RETURNED SAMPLE REVEALED SIGNIFICANT EMBOLIC COIL DAMAGE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7926537 ↗
• MalfunctionAug 15, 2018Physical Resistance/Sticking; Physical Resistance/Sticking

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF A TORTUOUS ANTERIOR COMMUNICATING ARTERY ANEURYSM, THE PHYSICIAN ATTEMPTED TO DEPLOY A 1.5X2 DELTAPLUSH CERE 10 SYS (CPL10015230/C37874) THERMO-MECHANICAL COIL, IN THE ANEURYSM, BUT THE PROWLER (UNK CATALOG AND LOT) MICROCATHETER WAS KICKING BACK. DURING THE DEPLOYMENT OF THE LAST LOOP, THE PHYSICIAN TRIED TO EXTRACT AND REDEPLOY THE COIL, BUT THE COIL WAS NOT ENTERING THE MICROCATHETER HUB AND STIFF RESISTANCE WAS ENCOUNTERED. THE PHYSICIAN REMOVED THE COIL AND MICROCATHETER, RESULTING IN A LOSS OF CEREBRAL TARGET POSITION. THE PHYSICIAN UTILIZED A GALAXY COIL WITH THE SAME PROWLER MICROCATHETER TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE SURGERY WAS NOT DELAYED DUE TO THE EVENT. REPORTEDLY, THE KICK-BACK DID NOT CAUSE THE COIL TO HERNIATE INTO THE PARENT VESSEL. THE MICROCATHETER DID NOT KINK OR BEND AT ANY TIME. THE OTHER PRODUCTS WERE USED SUCCESSFULLY WITH THE PROWLER MICROCATHETER AFTER THE REPORTED RESISTANCE. THE PRODUCTS WERE DISCARDED AND ARE THUS NOT AVAILABLE FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7784306 ↗
• MalfunctionJan 30, 2018Premature Activation; Premature Activation

  AS REPORTED BY AN AFFILIATE, DURING A COIL EMBOLIZATION TO AN UNKNOWN SITE, A DELTAPL CERE COIL (CPL10015230, C27809) AND A PRESIDIO 18 CERE ((B)(4), UNKNOWN LOT NUMBER) PRE-DETACHED WHEN THE COILS WERE ADVANCING THROUGH MICROCATHETER (MC). THE PHYSICIAN REMOVED TWO COILS SAFELY FROM THE MC AND USED ANOTHER SAME SIZE COILS. THERE WAS NO REPOT OF PATIENT INJURY. THE PRODUCTS WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7227536 ↗
• MalfunctionNov 22, 2017Kinked; Kinked

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT TWO DELTAPLUSH 1.5X2 COILS (CPL10015230/C31324 & CPL10015230/C26795) WERE ATTEMPTED TO BE USED DURING A 2 MM X 2.5 MM ANEURYSM COILING PROCEDURE IN THE INTERNAL CAROTID ARTERY WHEN TREMENDOUS FRICTION WAS EXPERIENCED IN THE PROWLER 14 MICROCATHETER (606151MX/17627070) AS THE PHYSICIAN WAS FEEDING THE DELIVERY WIRE OF THE COIL INTO THE CATHETER. THE EVENT OCCURRED WITH THE DELTAPLUSH 1.5X2 (COMPLAINT PRODUCT 1) SO THE PHYSICIAN DECIDED TO PULL IT OUT, RE-SHEATH IT, AND TRY IT AGAIN. THE SAME FRICTION OCCURRED. THEREFORE, THE PHYSICIAN PULLED IT OUT AND DISPOSED OF IT. THE PHYSICIAN THEN GRABBED A SECOND DELTAPLUSH 1.5X2 (COMPLAINT PRODUCT 2) AND EXPERIENCED THE SAME RESISTANCE IN THE SHEATH. THE SCRUB TECH PULLED THE ENTIRE COIL DELIVERY SYSTEM OUT AND ATTEMPTED TO RE-SHEATH IT ON THE BACK TABLE BUT THE COIL JUST BROKE OFF ON THE TABLE. REPORTEDLY, THE ENCOUNTERED RESISTANCE OCCURRED MIDWAY THROUGH THE PROWLER 14 MICROCATHETER AND THE COIL COULD NOT BE ADVANCED. THE PHYSICIAN THEN WENT TO USE A STRYKER NANO COIL BUT THE DELTAPLUSH COILS (COMPLAINT PRODUCTS) HAD KICKED OUT THE MICROCATHETER SO THE PHYSICIAN SAID ¿FORGET IT¿ AND DID NO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7054036 ↗
• MalfunctionSep 21, 2017Premature Activation; Premature Activation

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT TWO DELTAPLUSH 1.5X2 COILS (CPL10015230/C31324 & CPL10015230/C26795) WERE ATTEMPTED TO BE USED DURING A 2MMX2.5MM ANEURYSM COILING PROCEDURE IN THE INTERNAL CAROTID ARTERY WHEN TREMENDOUS FRICTION WAS EXPERIENCED IN THE PROWLER 14 MICROCATHETER (606151MX/17627070) AS THE PHYSICIAN WAS FEEDING THE DELIVERY WIRE OF THE COIL INTO THE CATHETER. THE EVENT OCCURRED WITH THE DELTAPLUSH 1.5X2 (COMPLAINT PRODUCT 1) SO THE PHYSICIAN DECIDED TO PULL IT OUT, RE-SHEATH IT, AND TRY IT AGAIN. THE SAME FRICTION OCCURRED. THEREFORE, THE PHYSICIAN PULLED IT OUT AND DISPOSED OF IT. THE PHYSICIAN THEN GRABBED A SECOND DELTAPLUSH 1.5X2 (COMPLAINT PRODUCT 2) AND EXPERIENCED THE SAME RESISTANCE IN THE SHEATH. THE SCRUB TECH PULLED THE ENTIRE COIL DELIVERY SYSTEM OUT AND ATTEMPTED TO RE-SHEATH IT ON THE BACK TABLE BUT THE COIL JUST BROKE OFF ON THE TABLE. REPORTEDLY, THE ENCOUNTERED RESISTANCE OCCURRED MIDWAY THROUGH THE PROWLER 14 MICROCATHETER AND THE COIL COULD NOT BE ADVANCED. THE PHYSICIAN THEN WENT TO USE A STRYKER NANO COIL BUT THE DELTAPLUSH COILS (COMPLAINT PRODUCTS) HAD KICKED OUT THE MICROCATHETER SO THE PHYSICIAN SAID ¿FORGET IT¿ AND DID NOT US

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6884241 ↗
• MalfunctionMar 8, 2017Device Inoperable; Device Inoperable

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING THE PROCEDURE A DELTAPLUSH CERECYTE 10 SYS COIL 1.5 X 2 FAILED TO DETACH. THE PROCEDURE WAS COIL EMBOLIZATION OF A CHOROIDAL ANEURYSM OF SIZE 3.5 X 4.2 MM. THE COIL DELIVERY SYSTEM CAUSED DCB ¿FAULT¿ WHEN CONNECTED AFTER INSERTED INTO PATIENT AND THE COIL WAS REMOVED. NO DETACHMENTS WERE ATTEMPTED. A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED, THE GREEN SYSTEM READY LIGHT DID NOT ILLUMINATE ALL CONNECTIONS APPEARED TO FIT PROPERLY WITHOUT APPLICATION OF EXCESSIVE FORCE. THE COMPLAINT COIL WAS WITHDRAWN AND A NEW COIL WAS USED TO COMPLETE THE PROCEDURE. THE SAME CONNECTING CABLE AND DETACHMENT BOX WERE USED SUCCESSFULLY WITH SUBSEQUENT COILS. THERE WERE NO DAMAGES NOTED ON THE COIL/COIL DELIVERY SYSTEM/DETACHMENT SYSTEM PRIOR TO USE OR UPON REMOVAL. THE COIL WAS STILL ATTACHED TO THE DELIVERY SYSTEM WHEN REMOVED FROM PATIENT AND NO STRETCHING WAS NOTED. THERE WAS NO REPORT ON PATIENT INJURY. IT WAS INITIALLY REPORTED THAT THE COMPLAINT COIL IS AVAILABLE FOR RETURN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6387648 ↗
• MalfunctionFeb 10, 2017Positioning Failure; Positioning Failure

  AS REPORTED BY A HEALTH CARE PROFESSIONAL, DURING THE PROCEDURE THE SURGEON WAS UNABLE TO DETACH A DELTAPLUSH COIL. THE PROCEDURE WAS COIL EMBOLIZATION OF AN ANEURYSM AT THE VERTEBRAL ARTERY ¿ POSTERIOR INFERIOR CEREBELLAR ARTERY. THE PATIENT¿S VESSELS WERE REPORTED TO BE MILDLY TORTUROUS AND MILDLY CALCIFIED. THE PHYSICIAN TRIED TO DETACH THE DELTAPLUSH COIL BUT COULD NOT. THE CABLE WAS REPLACED WITH A NEW CABLE BUT THE ISSUE CONTINUED. THE COIL WAS THEN REPLACED WITH ANOTHER ONE. 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 OR 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 INVESTIGATION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6321757 ↗

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