ARROW CS-15242-VSPRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10801902154221), received between Feb 17, 2026 and Jun 22, 2026 — classified as 4 malfunctions.

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

• MalfunctionJun 22, 2026Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT ON (B)(6) 2026, DURING USE OF A CANNON II PLUS RETROGRADE CHRONIC HEMODIALYSIS CATHETER (CHDC), IT WAS OBSERVED THAT THERE WERE CRACKS AND BLOOD OOZING FROM THE CONNECTOR. THE CATHETER HAD ORIGINALLY BEEN INSERTED ON (B)(6) 2026. THE AFFECTED DEVICE WAS REMOVED AND REPLACED WITH ANOTHER DEVICE, WHICH FUNCTIONED AS EXPECTED. THERE WERE NO REPORTS OF PATIENT INJURY, HARM, OR ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED AS "FINE." NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25586311 ↗
• MalfunctionMay 22, 2026Component Incompatible

  IT WAS REPORTED THAT ON (B)(6) 2026, "THE EVENT INVOLVED A 72-YEAR-OLD FEMALE PATIENT WHO WAS HAVING A TUNNELED CATHETER INSERTED FOR END-STAGE CHRONIC KIDNEY DISEASE AND GRAM-NEGATIVE BACTEREMIA. THE CATHETER COULD NOT BE INSERTED DUE TO A DEFECTIVE THREADED CONNECTION. AS A RESULT, THE DEVICE WAS REPLACED." PATIENT CONDITION WAS REPORTED AS "FINE". GOOD FAITH EFFORTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED DEVICE ISSUE AND THE PATIENT'S CLINICAL OUTCOME. HOWEVER, NO RESPONSE OR ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 25261288 ↗
• MalfunctionMay 11, 2026Obstruction of Flow; Failure to Disconnect; Separation Failure

  IT WAS REPORTED THAT ON (B)(6) 2026, DURING DISCONNECTION AT THE CONCLUSION OF A DIALYSIS SESSION, THE INLET LINE OF THE CANNON II PLUS CHDC (INSERTED ON (B)(6) 2026) COULD NOT BE REMOVED DESPITE MULTIPLE ATTEMPTS BY HEALTHCARE STAFF AND THE ATTENDING PHYSICIAN. IT WAS OBSERVED THAT A NON-TELEFLEX CONNECTOR HAD MELTED AND FRACTURED WITHIN THE RED CATHETER HUB. ALTHOUGH THE CONNECTOR COULD BE UNSCREWED, IT ROTATED FREELY AND COULD NOT BE REMOVED. AS A PRECAUTIONARY MEASURE, A SECOND CLAMP WAS APPLIED TO THE LINE USING AN APPLIER. A TEMPORARY CATHETER WAS INSERTED INTO THE LEFT INTERNAL JUGULAR VEIN IN THE INTENSIVE CARE UNIT. SUBSEQUENTLY, A REPLACEMENT TUNNELED CATHETER WAS INSERTED INTO THE RIGHT INTERNAL JUGULAR VEIN ON (B)(6) 2026. IT WAS REPORTED ON (B)(6) 2026 THAT THE PATIENT HAD PASSED AWAY; THE DEATH WAS REPORTED AS UNRELATED TO THIS INCIDENT.

  Patient problems: Insufficient Information

  MAUDE report 25135609 ↗
• MalfunctionFeb 17, 2026Crack

  IT WAS REPORTED THAT: "(B)(6) 2026, THE DOCTOR FOUND PATIENT'S TUNNELED CATHETER BLEEDING. THE LUER HUB/FITTING HAS CRACK AND THE BLEEDING IS A DIFFERENT DEFECT." ASSOCIATED COMPLAINTS: 9680794-2026-00111.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24363228 ↗