DELTAPAQ CERECYTE CDF100202-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00878528007067), received between Sep 23, 2016 and Aug 13, 2019 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Stretched” (4 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2019Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN COULD NOT ADVANCE NOR RETRIEVE THE 2MM X 2CM DELTAPAQ 10 CERECYTE COIL (CDF10020230 / S10531). AS A RESULT, THE PHYSICIAN HAD TO REMOVE BOTH THE COIL AND THE MICROCATHETER. THE COIL WAS INSPECTED AFTER REMOVAL AND WAS NOTED TO BE STRETCHED. THE PHYSICIAN USED ANOTHER 2MM X 2CM DELTAPAQ 10 CERECYTE COIL TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT COMPLICATION OR ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8889438 ↗
• MalfunctionAug 8, 2019Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION, A 2MMX2CM DELTAPAQ CERE (CDF10020230, S10819) WAS NOT ABLE TO ADVANCE NOR RETRIEVED BY THE PHYSICIAN. THE PHYSICIAN PULLED THE COIL AND MICROCATHETER (MC) AT THE SAME TIME. AFTER INSPECTION IT TURNS OUT TO BE STRETCHED. THE PHYSICIAN USED A SAME LIKE PRODUCT. THE PROCEDURE WAS SUCCESSFULLY FINISHED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8875348 ↗
• MalfunctionMar 14, 2019Stretched; Material Twisted/Bent; Stretched; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE ENPOWER CHECK LAMP DID NOT WORK. THERE WAS NO REPORT OF ANY PATIENT CONSEQUENCE. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NO FURTHER INFORMATION HAS BEEN PROVIDED. THE 2MM X 2CM DELTAPAQ 10 CERECYTE COIL (CDF10020230 / LOT# UNKNOWN) WAS RETURNED FOR EVALUATION WHICH REVEALED THE EMBOLIC COIL WAS KINKED AND IN A STRETCHED CONDITION. BASED ON THE PRODUCT ANALYSIS COMPLETED ON 3/8/2019, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8423110 ↗
• MalfunctionSep 6, 2018Positioning Failure; Positioning Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE, THE DELTAPAQ 10 CERECYTE COIL 2 MM X 2 CM (CDF10020230 / C34616) COULD NOT BE DETACHED. THE COIL WAS WITHDRAWN AND REPLACED; ANOTHER COIL WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY OR ADVERSE EVENT. IT WAS INDICATED THAT THE DELTAPAQ CERECYTE COIL IS AVAILABLE TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7851844 ↗
• MalfunctionSep 1, 2017Positioning Failure; Positioning Failure

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT A DELTAPAQ (CDF10020230/C37719) WAS USED DURING A COIL EMBOLIZATION PROCEDURE OF AN ANEURYSM IN THE POSTERIOR COMMUNICATING ARTERY (PCOM) WITH A SIZE OF 3.22X5.43MM WHERE THE COIL COULD NOT BE DETACHED. THE COIL WAS WITHDRAWN AND ANOTHER ONE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6838740 ↗
• MalfunctionSep 23, 2016Positioning Failure; Stretched; Positioning Failure; Stretched

  IT WAS REPORTED BY A CONTACT AT THE USER FACILITY THAT DURING A COIL EMBOLIZATION PROCEDURE THE DELTAPAQ COIL (CDF10020230/C24536) COULD NOT BE DETACHED. ALL CONNECTIONS APPEARED TO FIT PROPERLY WITHOUT APPLICATION OF EXCESSIVE FORCE AND A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED. THE COIL WAS STILL ATTACHED TO THE DELIVERY SYSTEM WHEN REMOVED FROM THE PATIENT; HOWEVER THE COIL WAS FOUND TO BE STRETCHED. A NEW COIL WAS USED TO COMPLETE THE PROCEDURE. THE SAME CONNECTING CABLE AND DETACHMENT CONTROL BOX WERE USED WITH SUBSEQUENT COILS. THE REPORTED EVENT DID NOT REQUIRE AN EXCHANGE OF THE MICROCATHETER. THERE WERE NO INTRA OR POST PROCEDURAL COMPLICATIONS OR SURGICAL DELAYS RELATED TO DEVICE OR REPORTED EVENT. THERE WERE NO DAMAGES NOTED ON THE COMPLAINT COIL PRIOR TO USE. THERE WAS NO REPORT ON PATIENT INJURY. IT WAS INITIALLY REPORTED THAT THE PRODUCT IS AVAILABLE FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5973674 ↗