CEREGLIDE NIC71125URecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886704085423), received between Sep 11, 2024 and Feb 4, 2026 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (2 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. How this data works · Data updated Oct 13, 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.

• MalfunctionFeb 4, 2026Material Twisted/Bent; Physical Resistance/Sticking

  A HEALTHCARE PROFESSIONAL REPORTED AN ISSUE OCCURRING DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE INVOLVING THE 125 CM CEREGLIDE 71 CATHETER (PRODUCT CODE: NIC71125U, LOT: 31722200) USED COAXIALLY WITH A NON¿J&J MICROCATHETER. DURING ADVANCEMENT, THE CEREGLIDE CATHETER BECAME IMPEDED AT THE C1¿C2 SEGMENT OF THE INTERNAL CAROTID ARTERY AND WAS UNABLE TO REACH THE INTENDED TARGET SITE. THE PHYSICIAN WITHDREW BOTH THE CEREGLIDE CATHETER AND THE MICROCATHETER. UPON REMOVAL, THE CEREGLIDE CATHETER WAS OBSERVED TO BE KINKED/BENT. THE PHYSICIAN REPLACED THE CEREGLIDE DEVICE WITH AN ALTERNATIVE BRAND CATHETER AND COMPLETED THE PROCEDURE SUCCESSFULLY USING THE ORIGINAL MICROCATHETER. NO DELAY IN THERAPY OR PROCEDURAL COMPLICATION WAS REPORTED. ADDITIONAL INFORMATION RECEIVED ON 02 FEB 2026 INDICATED THAT THE MICROCATHETER USED WAS IDENTIFIED AS A MEDTRONIC ECHELON10. VESSEL TORTUOSITY WAS PRESENT. NO PHYSICAL MATERIAL OR FOREIGN MATTER WAS IDENTIFIED INSIDE THE DEVICE. THERE WAS NO ALLEGATION OF PATIENT INJURY RELATED TO A PRODUCT ISSUE. NO PATIENT INJURY OR ADVERSE CLINICAL OUTCOME WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24260262 ↗
• MalfunctionNov 17, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A THROMBECTOMY PROCEDURE USING A 125M CEREGLIDE 71 CATHETER (NIC71125U / 31464782), THE FIRST ASPIRATION ATTEMPT WAS SUCCESSFUL. HOWEVER, AFTER REMOVING THE CEREGLIDE CATHETER TO ATTEMPT A SECOND ASPIRATION, THERE WERE TWO FLATTENED AREAS AT THE PROXIMAL END. IT WAS REPORTED THAT ¿EVEN A MICROWIRE COULD NOT PASS THROUGH.¿ THE PROCEDURE WAS CONTINUED USING A 5MM X 22MM EMBOTRAP III REVASCULARIZATION DEVICE AND A PHENOM¿ 27 MICROCATHETER (MEDTRONIC) TO RETRIEVE THE THROMBUS. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23576990 ↗
• MalfunctionAug 25, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED VIA A HEALTHCARE PROFESSIONAL THAT THIS WAS A MECHANICAL THROMBECTOMY OF AN OCCLUSION AT THE INTERNAL CAROTID ARTERY TO TREAT CEREBRAL INFARCTION, AFTER THE FIRST PASS WITH A 125CM CEREGLIDE 71 CATHETER (NIC71125C, 31526795), THE CEREGLIDE WAS PULLED FROM THE PATIENT'S BODY, AND FOUND A FLATTENED AREA OF APPROXIMATELY 2 CM AT THE TIP OF THE CATHETER. THE CEREGLIDE 71 WAS REPLACED WITH ANOTHER NEW ONE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. IT IS UNKNOWN IF A CONTINUOUS FLUSH WAS PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22883552 ↗
• MalfunctionJun 10, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE PHYSICIAN OPENED THE PACKAGE OF A 125M CEREGLIDE 71 CATHETER (NIC71125U / 31464782), BEFORE INTRODUCING THE CEREGLIDE CATHETER, THE PHYSICIAN NOTICED BRISK SALINE LEAKING AROUND THE HUB. THE DEVICE WAS NOT INTRODUCED INTO THE PATIENT. THERE WAS NO NEGATIVE PATIENT IMPACT. ON 09-JUN-2025, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE PROCEDURE DATE WAS ON (B)(6) 2025. THE DEVICE WAS REPLACED WITH ANOTHER 125M CEREGLIDE 71 CATHETER (NIC71125U) AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY ISSUE. THERE WAS A DELAY OF ¿MAYBE 1-2 MINUTES MAX,¿ BUT IT WAS NOT CLINICALLY SIGNIFICANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22181039 ↗
• MalfunctionJan 2, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  AS REPORTED BY THE FIELD, A 125CM CEREGLIDE 71 CATHETER (NIC71125C, 31395151) WAS PUSHED AT THE ACCESS, TILL THE VERY END TOUCHING THE Y ADAPTOR. PROBABLY DUE TO THE MANIPULATION AND CONTACT TO THE ACCESS SYSTEM THE PROXIMAL ¿NECK¿ OF THE CEREGLIDE SHAFT WAS BROKEN AND AIR WAS (WOULD) ENTER THE SYSTEM WHILE ASPIRATION THROUGH A WHOLE. THEY DID NOT CONTINUE AND CHANGED THE CATHETER TO ANOTHER COMPETITIVE BRAND AND CONTINUED SUCCESSFULLY WITH THE PROCEDURE, NO SIGNIFICANT DELAY, NO ADDITIONAL RISK, NO HARM HAPPENED TO THE PATIENT. THE PHYSICIAN ADMITTED THAT HE MIGHT SHOULD HAVE USED A LONGER CEREGLIDE TO AVOID IRRITATION AT THE PROXIMAL NECK, BUT HE STATED THAT THIS IS UNEXPECTED THAT THIS WOULD CAUSE DAMAGE, SINCE OTHER ASPIRATION CATHETERS WITHSTAND THIS TYPE OF MANIPULATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21055922 ↗
• InjurySep 11, 2024Difficult to Advance; Difficult to Advance

  IT WAS REPORTED, VIA ELECTRONIC MAIL, THAT A 125CM CEREGLIDE 71 CATHETER (NIC71125C / 31332257) WAS USED FOR A THROMBECTOMY PROCEDURE. DURING THE PROCEDURE, THE USER REPORTED THE CEREGLIDE 71 NEED TO BE REPLACED WITH THEIR STANDARD CATHETER, BECAUSE IT WAS NOT POSSIBLE TO REACH ABOVE THE OPHTHALMIC LIP WITH CEREGLIDE. THE EVENT WAS INITIALLY REPORTED AS SUCH, ¿THE CATHETER NEEDED TO BE CHANGED FROM CEREGLIDE TO THEIR STANDARD CATHETER, BECAUSE NOT POSSIBLE TO REACH ABOVE THE OPHTHALMIC LIP WITH CEREGLIDE, THIS WORKED AFTER CHANGING TO STANDARD CATHETER.¿ ON 26-AUG-2024, ADDITIONAL INFORMATION WAS RECEIVED. SUMMARY: PER THE INFORMATION, THE EVENT DID NOT RESULT IN ANY CONSEQUENCE OR INJURY TO THE PATIENT. REGARDING IF THE EVENT RESULTED IN ANY UNDUE PROCEDURAL DELAY OR CONSEQUENCE THAT COULD BE CONSIDERED CLINICALLY SIGNIFICANT, IT WAS REPORTED, ¿SLIGHT DELAY IN RECANALIZATION OF INTRACRANIAL OCCLUSION.¿ RELEVANT ANATOMICAL INFORMATION WAS REPORTED AS ¿SEVERE CAROTID TORTUOSITY.¿ THE DEVICE DID NOT APPEAR DAMAGED AT ANY TIME. A CONTINUOUS FLUSH WAS MAINTAINED. THE PATIENT IS A 39-YEAR-OLD FEMALE. NO FURTHER INFORMATION WAS MADE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20191229 ↗