DELTAPAQ CERECYTE CDF100306-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00878528007197), received between Aug 29, 2016 and Nov 4, 2020 — classified as 7 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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 4, 2020Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE 3MM X 6CM DELTAPAQ 10 CERECYTE COIL (CDF10030630 / L10056) COULD NOT BE RE-SHEATHED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE PROCEDURE AND THE REPORTED DEVICE ISSUE WERE UNSUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE, THIS FILE WILL BE UPDATED ACCORDINGLY. THE 3MM X 6CM DELTAPAQ 10 CERECYTE COIL WAS RETURNED FOR EVALUATION WHICH REVEALED THAT THE COIL WAS IN STRETCHED CONDITION. BASED ON THE PRODUCT ANALYSIS COMPLETED ON 11/04/2020, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10787947 ↗
• MalfunctionAug 8, 2019Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION, A 2.5MMX6CM DELTAPAQ CERE (CDF10025630, C40100), A 3MMX6CM DELTAPAQ CERECYTE (CDF10030630, S14317) AND A 5MMX10CM DELTAPAQ CERE (CDF10051030, S11295) WERE NOT ABLE TO ADVANCE NOR RETRIEVED BY THE PHYSICIAN. THE PHYSICIAN PULLED THE COILS 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 8874312 ↗
• MalfunctionMar 27, 2018Kinked; Kinked

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, ABNORMAL FRICTION WAS ENCOUNTERED BETWEEN THE COIL DELIVERY WIRE AND THE COIL INTRODUCER OF A 3MM X 6CM DELTAPAQ 10 CERECYTE THERMO-MECHANICAL COIL ((B)(4)/LOT UNKNOWN) AND A 1.5MM X 3CM DELTAPLUSH10 CERECYTE THERMO-MECHANICAL COIL ((B)(4)/LOT UNKNOWN). IT IS NOT KNOWN HOW THE PROCEDURE WAS COMPLETED OR IF THERE WAS ANY INJURY TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7372780 ↗
• MalfunctionMar 15, 2018Unraveled Material; Unraveled Material

  AS REPORTED BY AN AFFILIATE, THE COIL INTRODUCER WIRE OF A DELTAPAQ CERE COIL ((B)(4), UNKNOWN LOT) WAS KINKED. THERE WAS NO REPOT OF PATIENT INJURY. THE DEVICE WILL BE RETURNED FOR ANALYSIS. NO ADDITIONAL INFORMATION IS AVAILABLE. PER THE FAILURE ANALYSIS LAB (FAL), THE EMBOLIC COIL IS STRETCHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7340898 ↗
• MalfunctionNov 21, 2016Failure to Advance; Failure to Advance

  THE CONTACT FROM THE FACILITY REPORTED THAT THE DELTAPAQ COIL (B)(4) COULD NOT BE ADVANCED THROUGH THE EXCELSIOR SL-10 MICROCATHETER BODY AND WAS RETRIEVED BY THE PHYSICIAN. IT WAS THE 4TH COIL IN THE PROCEDURE. THE PHYSICIAN PULLED THE COIL AND EXCELSIOR SL-10 MICROCATHETER OUT AT THE SAME TIME. AFTER PULLING OUT THE COIL IT APPEARED TO BE STRETCHED. THE PHYSICIAN USED A SIMILAR PRODUCT TO FINISH THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY FINISHED. THE DEVICE DID NOT KINK OR BEND AT ANY TIME. THE CONCOMITANT PRODUCT REPORTEDLY BENT. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE CATHETER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6119358 ↗
• MalfunctionOct 12, 2016Stretched; Stretched

  AS REPORTED BY A HEALTH CARE PROFESSIONAL, DURING A COIL EMBOLIZATION PROCEDURE A DELTAPAQ CERE 3 MM X 6 CM (CDF10030630/C19942) STRETCHED. THE ENTIRE COIL WAS WITHDRAWN FROM THE MICROCATHETER AND NEW COIL WAS USED TO COMPLETE THE PROCEDURE; THE MICROCATHETER WAS NOT REMOVED. THERE WERE NO KINKS NOTED ON THE MICROCATHETER AND THERE WAS NO RESISTANCE BETWEEN THE MICROCATHETER AND GUIDEWIRE WHEN ACCESSING THE TARGET SITE. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER AT ALL TIMES. THERE WAS NO REPORT ON PATIENT INJURY AND NO REPORTS ON INTRA OR POST-PROCEDURAL COMPLICATIONS. PATIENT INFORMATION IS UNKNOWN. IT WAS INITIALLY REPORTED THAT THE COMPLAINT DEVICE IS AVAILABLE FOR RETURN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6021540 ↗
• MalfunctionAug 29, 2016Positioning Failure; Stretched; Positioning Failure; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, 5 DELTAPAQ COILS (CDF10015230/ C37792, CDF10025430/ C36045, CDF10020430/ C36101, CDF10020330/ C40094 AND CDF10030630/ C37174) FAILED TO DETACH. THE DETACHMENT CABLE AND DCB WERE CHANGED, BUT THE COILS COULD NOT BE DETACHED. ALL OF THE COILS WERE USED IN THE SAME CASE, BUT NOT USED CONSECUTIVELY. THERE WERE NO POTENTIAL PATIENT ADVERSE EVENTS. IT WAS REPORTED THAT PRODUCT WOULD BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5910179 ↗