Xcela 60M701532Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI H96560M7015320), received between Aug 17, 2021 and May 9, 2023 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Material Discolored” (9 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.

• MalfunctionMay 9, 2023Particulates; Particulates

  A DISTRIBUTOR REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A PICC FROM AN XCELA PASV 5F KIT. THE PICC HAD BEEN IN USE FOR 28 DAYS PRIOR TO THE REPORTED EVENT FOR A STEM CELL TRANSPLANT. WHILE DRAWING BLOOD, WHITE PARTICLES WERE NOTED IN THE DISPOSABLE SYRINGE, COMING FROM BOTH LUMENS. THE CATHETER WAS REMOVED. DUE TO THIS EVENT, THE PATIENT NEEDED A NEW PICC INSERTED, AND THE STEM CELL TRANSPLANT WAS DELAYED. THE FREQUENCY OF THE PICC USE BEFORE THIS EVENT WAS REPORTED AS INTERMITTENT FOR HYDRATION, MEDICATIONS, AND POTENTIAL BLOOD PRODUCTS. THE PARTICLES NOTED BY STAFF WERE NOT SUBMITTED FOR ANALYSIS BY THE FACILITY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM DUE TO THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16895771 ↗
• MalfunctionSep 15, 2021Material Discolored; Material Discolored

  AN END USER REPORTED AN ISSUE WITH A CAN 5F DUAL XCELA PICC. IT WAS REPORTED THAT, DURING VISUAL INSPECTION, ONE LUMEN OF THE PICC WAS NOTED TO BE CLOUDY YELLOW. THERE IS ALSO A "HOMOGENOUS CLOUDINESS" THROUGHOUT THE VISIBLE PORTION OF THE CATHETER. THE PICC WAS IN SITU FOR APPROXIMATELY 8 MONTHS BEFORE IT WAS REMOVED AND REPLACED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION BECAUSE OF THIS INCIDENT. THE REPORTED DEVICE HAS BEEN RETURNED TO THE MANUFACTURER AND AN INVESTIGATION INTO THE ROOT CAUSE FOR EVENT IS CURRENTLY IN PROGRESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12475954 ↗
• MalfunctionAug 24, 2021Material Discolored; Material Discolored

  1ST EVENT REPORTED VIA (B)(4), 1317056-2021-00144. 4TH OF 8 REPORTED EVENTS: A TERRITORY MANAGER REPORTED AN END USER HAD AN ISSUE WITH A CAN 5F DUAL XCELA PICC - (B)(6) KIT. IT WAS REPORTED THAT THERE WAS A DISCOLORATION OF THE PICC LUMEN. ON VISUAL INSPECTION, ONE LUMEN OF THE PICC NOTED TO BE CLOUDY OR DISCOLORED WHITE/GREY. THE LUMEN WAS KNOWN TO HAVE HAD UNDILUTED ETOPOSIDE INFUSED WITHIN. THE PICC WAS REMOVED FROM THE PATIENT AND REPLACED WITH A NEW OF THE SAME DEVICE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION BECAUSE OF THIS INCIDENT. IT WAS INDICATED THE REPORTED DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER FOR A DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12362623 ↗
• MalfunctionAug 24, 2021Material Discolored; Material Discolored

  1ST EVENT REPORTED VIA (B)(4), 1317056-2021-00144. 5TH OF 8 REPORTED EVENTS: A TERRITORY MANAGER REPORTED AN END USER HAD AN ISSUE WITH A CAN 5F DUAL XCELA PICC - (B)(6) KIT. IT WAS REPORTED THAT THERE WAS A DISCOLORATION OF THE PICC LUMEN. ON VISUAL INSPECTION, ONE LUMEN OF THE PICC NOTED TO BE CLOUDY OR DISCOLORED WHITE/GREY. THE LUMEN WAS KNOWN TO HAVE HAD UNDILUTED ETOPOSIDE INFUSED WITHIN. THE PICC WAS REMOVED FROM THE PATIENT AND REPLACED WITH A NEW OF THE SAME DEVICE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION BECAUSE OF THIS INCIDENT. IT WAS INDICATED THE REPORTED DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER FOR A DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12362622 ↗
• MalfunctionAug 24, 2021Material Discolored; Material Discolored

  1ST EVENT REPORTED VIA (B)(4), 1317056-2021-00144. 7TH OF 8 REPORTED EVENTS: A TERRITORY MANAGER REPORTED AN END USER HAD AN ISSUE WITH A CAN 5F DUAL XCELA PICC - (B)(6) HOSPITAL (STP) KIT. IT WAS REPORTED THAT THERE WAS A DISCOLORATION OF THE PICC LUMEN. ON VISUAL INSPECTION, ONE LUMEN OF THE PICC NOTED TO BE CLOUDY OR DISCOLORED WHITE/GREY. THE LUMEN WAS KNOWN TO HAVE HAD UNDILUTED ETOPOSIDE INFUSED WITHIN. THE PICC WAS REMOVED FROM THE PATIENT AND REPLACED WITH A NEW OF THE SAME DEVICE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION BECAUSE OF THIS INCIDENT. IT WAS INDICATED THE REPORTED DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER FOR A DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12362621 ↗
• MalfunctionAug 24, 2021Material Discolored; Material Discolored

  1ST EVENT REPORTED VIA (B)(4), 1317056-2021-00144. 6TH OF 8 REPORTED EVENTS: A TERRITORY MANAGER REPORTED AN END USER HAD AN ISSUE WITH A CAN 5F DUAL XCELA PICC - (B)(6) KIT. IT WAS REPORTED THAT THERE WAS A DISCOLORATION OF THE PICC LUMEN. ON VISUAL INSPECTION, ONE LUMEN OF THE PICC NOTED TO BE CLOUDY OR DISCOLORED WHITE/GREY. THE LUMEN WAS KNOWN TO HAVE HAD UNDILUTED ETOPOSIDE INFUSED WITHIN. THE PICC WAS REMOVED FROM THE PATIENT AND REPLACED WITH A NEW OF THE SAME DEVICE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION BECAUSE OF THIS INCIDENT. IT WAS INDICATED THE REPORTED DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER FOR A DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12362620 ↗
• MalfunctionAug 24, 2021Material Discolored; Material Discolored

  1ST EVENT REPORTED VIA (B)(4), 1317056-2021-00144. 3RD OF 8 REPORTED EVENTS: A TERRITORY MANAGER REPORTED AN END USER HAD AN ISSUE WITH A CAN 5F DUAL XCELA PICC - (B)(6) KIT. IT WAS REPORTED THAT THERE WAS A DISCOLORATION OF THE PICC LUMEN. ON VISUAL INSPECTION, ONE LUMEN OF THE PICC NOTED TO BE CLOUDY OR DISCOLORED WHITE/GREY. THE LUMEN WAS KNOWN TO HAVE HAD UNDILUTED ETOPOSIDE INFUSED WITHIN. THE PICC WAS REMOVED FROM THE PATIENT AND REPLACED WITH A NEW OF THE SAME DEVICE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION BECAUSE OF THIS INCIDENT. IT WAS INDICATED THE REPORTED DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR A DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12362618 ↗
• MalfunctionAug 24, 2021Material Discolored; Material Discolored

  1ST EVENT REPORTED VIA (B)(4), 1317056-2021-00144. 8TH OF 8 REPORTED EVENTS: A TERRITORY MANAGER REPORTED AN END USER HAD AN ISSUE WITH A CAN 5F DUAL XCELA PICC - (B)(6) KIT. IT WAS REPORTED THAT THERE WAS A DISCOLORATION OF THE PICC LUMEN. ON VISUAL INSPECTION, ONE LUMEN OF THE PICC NOTED TO BE CLOUDY OR DISCOLORED WHITE/GREY. THE LUMEN WAS KNOWN TO HAVE HAD UNDILUTED ETOPOSIDE INFUSED WITHIN. THE PICC WAS REMOVED FROM THE PATIENT AND REPLACED WITH A NEW OF THE SAME DEVICE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION BECAUSE OF THIS INCIDENT. IT WAS INDICATED THE REPORTED DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER FOR A DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12362617 ↗
• MalfunctionAug 24, 2021Material Discolored; Material Discolored

  1ST EVENT REPORTED VIA (B)(4), 1317056-2021-00144. 2ND OF 8 REPORTED EVENTS: A TERRITORY MANAGER REPORTED AN END USER HAD AN ISSUE WITH A CAN 5F DUAL XCELA PICC - (B)(6) KIT. IT WAS REPORTED THAT THERE WAS A DISCOLORATION OF THE PICC LUMEN. ON VISUAL INSPECTION, ONE LUMEN OF THE PICC NOTED TO BE CLOUDY OR DISCOLORED WHITE/GREY. THE LUMEN WAS KNOWN TO HAVE HAD UNDILUTED ETOPOSIDE INFUSED WITHIN. THE PICC WAS REMOVED FROM THE PATIENT AND REPLACED WITH A NEW OF THE SAME DEVICE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION BECAUSE OF THIS INCIDENT. IT WAS INDICATED THE REPORTED DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR A DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12362616 ↗
• MalfunctionAug 17, 2021Material Discolored; Material Discolored

  A TERRITORY MANAGER REPORTED AN END USER HAD AN ISSUE WITH A CAN 5F DUAL XCELA PICC - UHN MOUNT SINAI HOSPITAL (STP) KIT. IT WAS REPORTED THAT THERE WAS A DISCOLORATION OF THE PICC LUMEN. ON VISUAL INSPECTION, ONE LUMEN OF THE PICC NOTED TO BE CLOUDY OR DISCOLORED WHITE/GREY. THE LUMEN WAS KNOWN TO HAVE HAD UNDILUTED ETOPOSIDE INFUSED WITHIN. THE PICC WAS REMOVED FROM THE PATIENT AND REPLACED WITH A NEW OF THE SAME DEVICE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION BECAUSE OF THIS INCIDENT. IT WAS INDICATED THE REPORTED DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR A DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12330503 ↗