Celsius FLTR D135502Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10846835013078), received between Aug 9, 2019 and Mar 16, 2023 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Expiration Date Error” (6 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.

• MalfunctionMar 16, 2023Expiration Date Error; Expiration Date Error

  IT WAS REPORTED THAT EXPIRED PRODUCTS (CELSIUS¿ ELECTROPHYSIOLOGY CATHETER QTY 4) WERE RECEIVED. ACCORDING TO THE CUSTOMER, EXPIRATION DATE LABEL ON PRODUCT SHOW 22-SEP-2022. THE CUSTOMER RECEIVED THE PRODUCTS ON 03-FEB-2023. NO PATIENT WAS INVOLVED. THE EXPIRED PRODUCT SHIPPED ISSUE IS MDR REPORTABLE TO THE FDA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16553993 ↗
• MalfunctionMar 16, 2023Expiration Date Error; Expiration Date Error

  IT WAS REPORTED THAT EXPIRED PRODUCTS (CELSIUS¿ ELECTROPHYSIOLOGY CATHETER QTY 4) WERE RECEIVED. ACCORDING TO THE CUSTOMER, EXPIRATION DATE LABEL ON PRODUCT SHOW (B)(6)2022. THE CUSTOMER RECEIVED THE PRODUCTS ON (B)(6)2023. NO PATIENT WAS INVOLVED. THE EXPIRED PRODUCT SHIPPED ISSUE IS MDR REPORTABLE TO THE FDA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16553992 ↗
• MalfunctionMar 16, 2023Expiration Date Error; Expiration Date Error

  IT WAS REPORTED THAT EXPIRED PRODUCTS (CELSIUS¿ ELECTROPHYSIOLOGY CATHETER QTY 4) WERE RECEIVED. ACCORDING TO THE CUSTOMER, EXPIRATION DATE LABEL ON PRODUCT SHOW 22-SEP-2022. THE CUSTOMER RECEIVED THE PRODUCTS ON 03-FEB-2023. NO PATIENT WAS INVOLVED. THE EXPIRED PRODUCT SHIPPED ISSUE IS MDR REPORTABLE TO THE FDA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16553987 ↗
• MalfunctionMar 16, 2023Expiration Date Error; Expiration Date Error

  IT WAS REPORTED THAT EXPIRED PRODUCTS (CELSIUS¿ ELECTROPHYSIOLOGY CATHETER QTY 4) WERE RECEIVED. ACCORDING TO THE CUSTOMER, EXPIRATION DATE LABEL ON PRODUCT SHOW 22-SEP-2022. THE CUSTOMER RECEIVED THE PRODUCTS ON 03-FEB-2023. NO PATIENT WAS INVOLVED. THE EXPIRED PRODUCT SHIPPED ISSUE IS MDR REPORTABLE TO THE FDA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16553986 ↗
• MalfunctionAug 9, 2019Expiration Date Error; Expiration Date Error

  A CUSTOMER REPORTED RECEIVING TWO EXPIRED CELSIUS¿ ELECTROPHYSIOLOGY CATHETERS AND THE LOT NUMBER ON THE DEVICES WAS DIFFERENT FROM THE LOT NUMBER ON THE INVOICE. THE LOT # ON THE INVOICE WAS REPORTED AS 30183003M WITH THE LOT # ON THE DEVICE PACKAGING AS 30071387M. NO PATIENT CONSEQUENCES WERE REPORTED. ON 7/29/2019, THE COMPLAINT PRODUCT WAS RETURNED TO BIOSENSE WEBSTER INC.¿S (BWI) PRODUCT ANALYSIS LAB (PAL) FOR EVALUATION. INITIAL VISUAL ANALYSIS FOUND THE DEVICE WAS NEVER USED. IT WAS FOUND IN THE SEALED ORIGINAL POUCHES. THE LOT # 30071387M WAS RECEIVED AND BEYOND THE EXPIRATION DATE. THESE FINDINGS WERE CONSISTENT WITH THE CUSTOMER¿S REPORTED ISSUE. THE CUSTOMER¿S REPORTED ISSUE OF EXPIRED PRODUCT BEING SHIPPED AS BEEN ASSESSED AS AN MDR REPORTABLE MALFUNCTION. THE CUSTOMER REPORTED TWO DEVICES WERE AFFECTED, THEREFORE, BIOSENSE WEBSTER MANUFACTURER'S REFERENCE NUMBER (B)(4) HAS TWO MDRS FOR THE REPORTED EVENT: MFR # 2029046-2019-03534 FOR PRODUCT CODE D135502 (CELSIUS¿ ELECTROPHYSIOLOGY CATHETERS). MFR # 2029046-2019-03535 FOR PRODUCT CODE D135502 (CELSIUS¿ ELECTROPHYSIOLOGY CATHETERS).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8880782 ↗
• MalfunctionAug 9, 2019Expiration Date Error; Expiration Date Error

  A CUSTOMER REPORTED RECEIVING TWO EXPIRED CELSIUS¿ ELECTROPHYSIOLOGY CATHETERS AND THE LOT NUMBER ON THE DEVICES WAS DIFFERENT FROM THE LOT NUMBER ON THE INVOICE. THE LOT # ON THE INVOICE WAS REPORTED AS 30183003M WITH THE LOT # ON THE DEVICE PACKAGING AS 30071387M. NO PATIENT CONSEQUENCES WERE REPORTED. ON 7/29/2019, THE COMPLAINT PRODUCT WAS RETURNED TO BIOSENSE WEBSTER INC.¿S (BWI) PRODUCT ANALYSIS LAB (PAL) FOR EVALUATION. INITIAL VISUAL ANALYSIS FOUND THE DEVICE WAS NEVER USED. IT WAS FOUND IN THE SEALED ORIGINAL POUCHES. THE LOT # 30071387M WAS RECEIVED AND BEYOND THE EXPIRATION DATE. THESE FINDINGS WERE CONSISTENT WITH THE CUSTOMER¿S REPORTED ISSUE. THE REPORTED ISSUE OF EXPIRED PRODUCT BEING SHIPPED AS BEEN ASSESSED AS AN MDR REPORTABLE MALFUNCTION. THE CUSTOMER REPORTED TWO DEVICES WERE AFFECTED, THEREFORE, BIOSENSE WEBSTER MANUFACTURER'S REFERENCE NUMBER (B)(4) HAS TWO MDRS FOR THE REPORTED EVENT: MFR # 2029046-2019-03534 FOR PRODUCT CODE D135502 (CELSIUS¿ ELECTROPHYSIOLOGY CATHETERS). MFR # 2029046-2019-03535 FOR PRODUCT CODE D135502 (CELSIUS¿ ELECTROPHYSIOLOGY CATHETERS).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8880774 ↗