DELTAPLUSH CERECYTE CPL100151-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00878528008163), received between Sep 7, 2017 and Sep 9, 2020 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Positioning Problem” (4 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2020Positioning Problem; Positioning Problem

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A DELTAPL CERE COIL 10 SYS 1.5X1 (CPL10015130, S11750) WAS BEING USED AS A FILLING COIL. THE PHYSICIAN DIDN'T LIKE THE SHAPE OF THE COIL DEPLOYMENT, AND DECIDED TO PULL IT OUT. DURING THE RESHEATHING OF THE COIL, THE INTRODUCER FAILED TO BE RE-ZIPPED. THE PHYSICIAN USED A SAME LIKE PRODUCT. THE PROCEDURE WAS SUCCESSFULLY FINISHED. THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10507800 ↗
• MalfunctionAug 11, 2020Positioning Problem; Positioning Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 1.5MM X 1CM DELTAPLUSH 10 CERECYTE COIL (CPL10015130 / C38361) WAS CHOSEN AS THE FINISHING COIL FOR THE PROCEDURE; IT WAS REPORTED THAT THE PHYSICIAN DID NOT LIKE THE SHAPE OF THE COIL DEPLOYMENT AND DECIDED TO REMOVE THE COIL. DURING THE RESHEATHING ATTEMPT, THE COIL INTRODUCER FAILED TO BE RE-ZIPPED. THE PHYSICIAN USED ANOTHER 1.5MM X 1CM DELTAPLUSH 10 CERECYTE COIL AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10393925 ↗
• MalfunctionMar 17, 2020Positioning Problem; Positioning Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN DID NOT LIKE THE SHAPE OF THE 1.5MM X 1CM DELTAPLUSH 10 CERECYTE COIL (CPL10015130 / S12610) DEPLOYMENT AND DECIDED TO REMOVE THE COIL. DURING THE RESHEATHING ATTEMPT, THE COIL INTRODUCER FAILED TO BE RE-ZIPPED. THE PHYSICIAN USED ANOTHER 1.5MM X 1CM DELTAPLUSH 10 CERECYTE COIL AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9844878 ↗
• MalfunctionMar 16, 2020Positioning Problem; Positioning Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 1.5MM X 1CM DELTAPLUSH 10 CERECYTE COIL (CPL10015130 / S14367) WAS USED IN THE PROCEDURE; IT WAS REPORTED THAT THE PHYSICIAN DID NOT LIKE THE SHAPE OF THE COIL DEPLOYMENT AND DECIDED TO REMOVE THE COIL. DURING THE RESHEATHING ATTEMPT, THE COIL INTRODUCER FAILED TO BE RE-ZIPPED. THE PHYSICIAN USED ANOTHER 1.5MM X 1CM DELTAPLUSH 10 CERECYTE COIL AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9836843 ↗
• MalfunctionOct 24, 2019Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 1.5MM X 1CM DELTAPLUSH 10 CERECYTE COIL (CPL10015130 / S14368) WAS THE FIRST COIL USED DURING THE PROCEDURE. THE PHYSICIAN REPORTED THAT STRONG RESISTANCE WAS FELT DURING THE ADVANCEMENT OF THE COIL THROUGH THE PROWLER MICROCATHETER (UNKNOWN CATALOG/LOT NUMBER) AT THE DISTAL AREA OF THE MICROCATHETER. THE COIL WAS REPLACED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. THE 1.5MM X 1CM DELTAPLUSH 10 CERECYTE COIL WAS RETURNED FOR EVALUATION WHICH REVEALED THAT THE EMBOLIC COIL WAS STRETCHED. BASED ON THE PRODUCT ANALYSIS ON 10/23/2019, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9236164 ↗
• MalfunctionJan 30, 2019Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE TARGET VESSEL UNKNOWN, THE 1.5MM X 1CM DELTAPLUSH 10 CERECYTE COIL (CPL10015130/LOT# UNKNOWN) WAS DEPLOYED, BUT THE PHYSICIAN DID NOT LIKE THE COIL SHAPE AND REMOVED THE COIL. DURING RESHEATHING/RE-ZIPPING, THE COIL INTRODUCER FAILED TO RESHEATH/RE-ZIP. ANOTHER COIL WAS USED; IT WAS REPORTED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY PATIENT CONSEQUENCE OR ADVERSE EVENT. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. THE COMPLAINT DOCUMENTED THE 1.5MM X 1CM DELTAPLUSH 10 CERECYTE COIL, HOWEVER, THE PRODUCT THAT WAS RECEIVED FOR EVALUATION AND ANALYSIS DID NOT MATCH THE ORIGINALLY DOCUMENTED COMPLAINT DEVICE. PER THE AFFILIATE, THERE IS A POSSIBILITY THE RECEIVED COIL WAS MISMATCHED WITH THE PACKAGING BOX DURING REPACKING FOR RETURN BY THE HEALTHCARE PROFESSIONAL. THE RECEIVED DEVICE UNDERWENT EVALUATION TESTING WHICH REVEALED THAT THE COIL WAS STRETCHED. BASED ON THE PRODUCT ANALYSIS COMPLETED ON 1/10/2019, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8290901 ↗
• MalfunctionJan 30, 2019Material Fragmentation; Material Fragmentation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE TARGET VESSEL UNKNOWN, THE 1.5MM X 1CM DELTAPLUSH 10 CERECYTE COIL (CPL10015130 / LOT# UNKNOWN) WAS DEPLOYED, BUT THE PHYSICIAN DID NOT LIKE THE COIL SHAPE AND REMOVED THE COIL. DURING RESHEATHING / RE-ZIPPING, THE COIL INTRODUCER FAILED TO RESHEATH / RE-ZIP. ANOTHER COIL WAS USED; IT WAS REPORTED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY PATIENT CONSEQUENCE OR ADVERSE EVENT. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. THE 1.5MM X 1CM DELTAPLUSH 10 CERECYTE COIL WAS RETURNED FOR EVALUATION WHICH REVEALED THAT THE COIL WAS BROKEN. BASED ON THE PRODUCT ANALYSIS COMPLETED ON 1/10/2019, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8290897 ↗
• MalfunctionAug 6, 2018Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE WHEN THE PHYSICIAN ATTEMPTED TO DETACH THE DELTAPLUSH 10 CERECYTE COIL 1.5MM X 1CM (CPL10015130 / LOT# UNAVAILABLE), THE DETACHMENT CONTROL MADE THE NORMAL BEEPING SOUND BUT WHEN THE PHYSICIAN WAS RETRIEVING THE DELIVERY SYSTEM, THE COIL FAILED TO DETACH. THE PHYSICIAN USED ANOTHER DELTAPLUSH COIL AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF PATIENT INJURY OR ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7752571 ↗
• MalfunctionAug 6, 2018Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE WHEN THE PHYSICIAN ATTEMPTED TO DETACH THE DELTAPLUSH 10 CERECYTE COIL 1.5MM X 1CM (CPL10015130 / LOT# UNAVAILABLE), THE DETACHMENT CONTROL MADE THE NORMAL BEEPING SOUND BUT WHEN THE PHYSICIAN WAS RETRIEVING THE DELIVERY SYSTEM, THE COIL FAILED TO DETACH. THE PHYSICIAN USED ANOTHER DELTAPLUSH COIL AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF PATIENT INJURY OR ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7752563 ↗
• MalfunctionAug 6, 2018Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE WHEN THE PHYSICIAN ATTEMPTED TO DETACH THE DELTAPLUSH 10 CERECYTE COIL 1.5MM X 1CM (CPL10015130 / LOT# UNAVAILABLE), THE DETACHMENT CONTROL MADE THE NORMAL BEEPING SOUND BUT WHEN THE PHYSICIAN WAS RETRIEVING THE DELIVERY SYSTEM, THE COIL FAILED TO DETACH. THE PHYSICIAN USED ANOTHER DELTAPLUSH COIL AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF PATIENT INJURY OR ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7752560 ↗
• MalfunctionApr 17, 2018Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, THE ENPOWER DETACHMENT CONTROL BOX (DCB) TEST LAMP WAS NOT ON WITH THE USE OF THE 1.5MM X 1CM DELTAPLUSH THERMO-MECHANICAL DETACHABLE COIL SYSTEM (DCS) (CPL10015130/UNKNOWN LOT). IT IS NOT KNOWN HOW THE PROCEDURE WAS COMPLETED OR IF THERE WAS ANY PATIENT INJURY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7438605 ↗
• MalfunctionSep 7, 2017Positioning Failure; Positioning Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, A DELTAPLUSH COIL (CPL10015130/ S10730) FAILED TO DETACH DURING THE INTERNAL CAROTID ARTERY COILING PROCEDURE AND WAS REMOVED FROM THE PATIENT WITHOUT STRETCHING OR DETACHING. THE PROCEDURE WAS CONTINUED WITH THE SAME CONNECTING CABLE AND DETACHMENT BOX. A PRE-DEPLOYMENT ELECTRICAL CHECK HAD BEEN PERFORMED AND A FAULT LIGHT HAD NOT BEEN SEEN DURING THE CASE. UPON PRESSING THE POWER BUTTON, ALL LIGHTS ILLUMINATED. THE GREEN SYSTEM READY LIGHT ILLUMINATED. DURING THE DETACHMENT CYCLE, THE DETACHMENT LIGHT ILLUMINATED AND THE AUDIBLE SIGNAL BEEPED. ALL CONNECTIONS APPEARED TO FIT PROPERLY WITHOUT APPLICATION OF EXCESSIVE FORCE. THERE WERE NO POTENTIAL ADVERSE EVENTS OR PROCEDURE DELAYS. IT WAS REPORTED THAT THE DEVICE WOULD BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6848562 ↗
• MalfunctionSep 7, 2017Positioning Failure; Positioning Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, A DELTAPLUSH COIL (B)(4) FAILED TO DETACH DURING THE INTERNAL CAROTID ARTERY PROCEDURE. THE COIL WAS REMOVED FROM THE PATIENT STILL ATTACHED TO THE DELIVERY SYSTEM AND WAS NOT STRETCHED, AND THE PROCEDURE WAS CONTINUED USING THE SAME DETACHMENT CONTROL BOX AND CONNECTING CABLE. A PRE-DEPLOYMENT ELECTRICAL CHECK HAD BEEN PERFORMED. A FAULT LIGHT WAS NOT SEEN DURING THE CASE. THE SYSTEM READY LIGHT ILLUMINATED AND DURING DETACHMENT CYCLE, THE DETACHMENT LIGHT ILLUMINATED AND THE AUDIBLE SIGNAL BEEPED. ALL CONNECTIONS APPEARED TO FIT PROPERLY WITHOUT APPLICATION OF EXCESSIVE FORCE. THERE WERE NO POTENTIAL ADVERSE EVENTS OR PROCEDURE DELAY. IT WAS REPORTED THAT THE DEVICE WOULD BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6848526 ↗
• MalfunctionSep 7, 2017Positioning Failure; Positioning Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, A DELTAPLUSH COIL (CPL10015130/ S10730) FAILED TO DETACH DURING THE INTERNAL CAROTID ARTERY PROCEDURE AND WAS SUCCESSFULLY REMOVED FROM THE PATIENT WITHOUT STRETCHING OR DETACHMENT. THE PROCEDURE WAS CONTINUED WITH THE SAME DETACHMENT CONTROL BOX AND CONNECTING CABLE. A PRE-DEPLOYMENT ELECTRICAL CHECK HAD BEEN PERFORMED. A FAULT LIGHT WAS NOT SEEN DURING THE CASE, AND UPON PRESSING THE POWER BUTTON, ALL LIGHTS ILLUMINATED. THE SYSTEM READY LIGHT ILLUMINATED. UPON PRESSING THE DETACHMENT CYCLE, THE DETACHMENT LIGHT ILLUMINATED AND THE AUDIBLE SIGNAL BEEPED. ALL CONNECTIONS APPEARED TO FIT PROPERLY WITHOUT APPLICATION OF EXCESSIVE FORCE. THERE WERE NO POTENTIAL ADVERSE EVENTS OR PROCEDURE DELAYS. IT WAS REPORTED THAT THE DEVICE WOULD BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6848017 ↗

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