CLEARLINK 1C8687Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00085412068268), received between Jan 15, 2018 and Dec 17, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Disconnection” (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. 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 17, 2025Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT A CLEARLINK SYSTEM BLOOD BAG SPIKE ADAPTER CAME LOOSE FROM THE BAG. THE ISSUE WAS FURTHER DESCRIBED AS, APPROXIMATELY 5ML OF STEM CELLS WAS LOST. AN UNSPECIFIED SYRINGE WAS BEING USED TO WITHDRAW STEM CELLS FOR SAMPLING. THE PROCEDURE WAS PERFORMED DURING THERAPY, AND THE MEDICATION USED DURING THE PROCEDURE WAS 'ACDA'. THE BLOOD SPIKE WAS SUBSEQUENTLY REINSERTED INTO THE COLLECTION BAG. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23829154 ↗
• MalfunctionAug 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TUBING OF TWO (2) CLEARLINK BLOOD BAG SPIKE ADAPTERS SEPARATED FROM THE LUER ACTIVATED VALVE. ONE SET WAS BEING USED TO TRANSFER A REAGENT FROM A SYRINGE TO A TRANSFER PACK THAT WAS SPIKED WITH THIS CONNECTOR. THE LUER CONNECTOR DETACHED FROM THE SPIKE CONNECTOR WHEN THE OPERATOR WAS DETACHING THE SYRINGE FROM THE CONNECTOR POST REAGENT TRANSFER. THIS OCCURRED DURING CLINICAL MANUFACTURING OF A PATIENT PRODUCT IN A GMP FACILITY. THE REPORTER FURTHER STATED THAT THEY PERFORMED A 100% CHECK ON ALL REMAINING CONNECTORS AND FOUND AN ADDITIONAL ONE OF THE CONNECTORS WHERE THE FEMALE LUER VALVE DETACHED FROM THE SPIKE CONNECTOR. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22885193 ↗
• MalfunctionAug 13, 2024Illegible Information; Illegible Information

  IT WAS REPORTED THAT THE LABELING ON THE PACKAGING OF A CLEARLINK SYSTEM BLOOD BAG SPIKE ADAPTER WAS ILLEGIBLE. THE PLASTIC PACKAGING HAD SIGNIFICANT BLEEDING/RUNNING OF INK WHEN WIPED WITH STERILE 70% ISOPROPYL ALCOHOL AS REQUIRED DURING PHARMACY STERILE COMPOUNDING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19977911 ↗
• MalfunctionJul 9, 2024Illegible Information; Illegible Information

  IT WAS REPORTED THAT LABELING OF SIXTY (60) CLEARLINK SYSTEM BLOOD BAG SPIKE ADAPTERS WAS ILLEGIBLE. THE PRINTED LABELING ON THE PACKAGING HAD SIGNIFICANT BLEEDING/RUNNING OF INK WHEN WIPED WITH STERILE 70% ISOPROPYL ALCOHOL WHICH MADE THE LABELING ILLEGIBLE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19702694 ↗
• MalfunctionMar 4, 2024No Flow; No Flow

  IT WAS REPORTED THAT THERE WAS FLOWING DIFFICULTY DURING USE OF A CLEARLINK BLOOD BAG SPIKE ADAPTER LUER ACTIVATED VALVE CAUSING A "SLOW FLOW" ALARM ON AN UNSPECIFIED PUMP. THIS WAS OBSERVED DURING USE IN A CLEAN ROOM. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18830482 ↗
• MalfunctionMar 1, 2024No Flow; No Flow

  IT WAS REPORTED A CLEARLINK SYSTEM BLOOD BAG SPIKE WOULD NOT FLOW. THE CONNECTOR WAS SPIKED INTO A BAG, AND TRANSFER OF LIQUID WAS DONE THROUGH THE BLOOD BAG SPIKE CONNECTOR USING A SYRINGE. WHEN A MALE TUBING CONNECTOR WAS ATTACHED TO THE BLOOD BAG SPIKE ADAPTER IT DID NOT ALLOW FLOW OF LIQUID OUT OF THE BAG. THIS OCCURRED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18818687 ↗
• MalfunctionOct 19, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A PARTICLE WAS OBSERVED IN ONE OF THE FINAL PRODUCT BAGS DURING USE WITH A CLEARLINK SYSTEM BLOOD BAG SPIKE ADAPTER LUER. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17968847 ↗
• MalfunctionMay 11, 2018Disconnection; Disconnection

  IT WAS REPORTED THAT THE A CLEARLINK SYSTEM BLOOD BAG SPIKE ADAPTER HAD SEPARATED INTO PIECES. THIS EVENT OCCURRED DURING PRIMING AND BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 7506655 ↗
• MalfunctionMar 2, 2018Degraded; Fluid/Blood Leak; Degraded; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF CLEARLINK BLOOD BAG SPIKE ADAPTERS WERE LEAKING. THE ADAPTERS LEAK WHEN THEY ARE USED TO PUSH THE REAGENT, DIMETHYL SULFOXIDE (DMSO). IT WAS REPORTED THAT THE PLASTIC HOUSING SURROUNDING THE RUBBER PORT OF THE SET DETERIORATE/BREAKS APART AFTER THE DMSO IS PUSHED THROUGH WHICH RESULTS IN LEAKS. THE REPORTER ADVISED THAT THEY DO NOT USE THE BLOOD BAG SPIKE ADAPTER FOR IV ACCESS WITHIN THEIR FACILITY. THEIR OPERATIONS STAFF USES THE ADAPTER TO MAKE A CRYOPRESERVATION MEDIA FOR THEIR STEM CELL PRODUCTS AND THE DMSO PROTECTS THE CELLS DURING THE FREEZING PROCESS. SO, THE STAFF HAD BEEN TRANSFERRING THE DMSO FROM ITS ORIGINAL CONTAINER TO ANOTHER BAG TO STORE THE CRYOPROTECTANT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7309499 ↗
• MalfunctionJan 15, 2018Crack; Crack

  IT WAS REPORTED THAT EIGHT (8) CLEARLINK BLOOD BAG SPIKE ADAPTERS WERE CRACKED. DURING SET-UP/PRIME, THE SPIKE ADAPTERS WERE OBSERVED CRACKED. PER THE REPORTER, ¿MULTIPLE¿ MEDICATIONS WERE BEING USED DURING PRIME (NO FURTHER INFORMATION WAS PROVIDED). THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 7190856 ↗