CryoMACS® Freezing Bag 750 74403Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 04049934000300), received between Oct 9, 2019 and Sep 23, 2024 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Fracture” (10 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 18, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2024Fracture; Appropriate Device Problem Term/Code Not Available; Fracture; Appropriate Device Problem Term/Code Not Available

  THE CUSTOMER REPORTED A BAG WHERE OVERWRAP BAG AND CRYOMACS BAG WERE BROKEN DURING THAWING. ACCORDING TO THE QUESTIONNAIRE THE FOLLOWING INVESTIGATION AND STATEMENTS COULD BE MADE: THE EVENT WAS OBSERVED DURING THAWING. THE CUSTOMER DID USE METAL CASSETTES FOR FREEZING AND FOR STORAGE. A CONTROLLED RATE FREEZER WAS USED. AN OVERWRAP BAG WAS USED. THE FILLING VOLUME WAS 100 ML (80 TO 190 ML ARE RECOMMENDED). THE CRYOMACS FREEZING BAG WAS STORED IN THE VAPOR PHASE OF LN2. PICTURES OF THE CRACKED CRYOMACS FREEZING BAG WERE PROVIDED. THE ISSUE OF THE CRACKS CAN BE CONFIRMED. THE BAG WAS CRACKED AT THE UPPER PART OF THE BAG NEAR ONE OF THE SPIKE PORTS. THE ISSUE IS LIKELY CAUSED BY PHYSICAL STRESS, E.G. MECHANICAL IMPACT IN COMBINATION WITH AN IMPROPER USER HANDLING DURING THE FREEZING PROCEDURE. THE BAG MAY HAVE BEEN SLIGHTLY PINCHED IN THE METAL CASSETTE OR THE METAL CASSETTE IN WHICH THE FROZEN BAG WAS STORED WAS ROUGHLY MOVED AFTER FREEZING AND LEAD TO THE CRACK. AIR BUBBLES MAY HAVE BEEN TRAPPED INSIDE THE CRYOMACS FREEZING BAG OR BETWEEN THE OVERWRAP BAG AND THE CRYOMACS FREEZING BAG. TRAPPED AIR SHOULD ABSOLUTELY BE AVOIDED AS IT WILL EXPAND AFTER THE FREEZING PROCESS AND MAY CAU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20279560 ↗
• MalfunctionApr 9, 2024Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available; Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available

  THE CUSTOMER REPORTED BREAKAGE OF CONNECTOR. A FILLED IN QUESTIONAIRE ABOUT THE FREEZING PROCESS WAS PROVIDED. NO PHOTO WAS PROVIDED AND ALSO NO CLEAR DESCRIPTION OF THE INCIDENT. AS THE CUSTOMER REPORTED THE CASE TO HIS AUTHORITY IT IS ASSUMED THAT THE CELLULAR MATERIAL WAS LOST FOR THE TREATMENT. ACCORDING TO THE QUESTIONNAIRE THE FOLLOWING INVESTIGATION AND STATEMENTS COULD BE MADE: THE EVENT WAS OBSERVED DURING FREEZING/STORAGE. THE CUSTOMER DID NOT USE A METAL CASSETTE FOR FREEZING OR FOR STORAGE. A CONTROLLED RATE FREEZER WAS NOT USED. AN OVERWRAP BAG WAS NOT USED. THE FILLING VOLUME IS NOT KNOWN. THE FREEZING BAGS WERE STORED IN THE VAPOR PHASE OF LN2. NO PICTURES WERE PROVIDED. ACCORDING TO THE DESCRIPTION IT IS SUSPECTED THAT THE CRYOMACS FREEZING BAG IS CRACKED AT THE CONNECTION OF THE BAG TO THE EVA TUBE. DUE TO LACK OF INFORMATION NO CLEAR STATEMENT CAN BE GIVEN. FOR THE CRYOMACS FREEZING BAG 750 BATCH 7230600613, WITH REGARD TO THE COMPLAINT, NO DEVIATION CONCERNING THE MANUFACTURING PROCESS OCCURRED. NO ANOMALIES OCCURRED DURING THE PROCESS. WHEN CORRECTLY USED ACCORDING TO THE INSTRUCTIONS FOR USE THE ACCEPTED RISK LIMIT FROM THE RISK ASSESSMENT IS (B)(4). THIS IS TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19070479 ↗
• MalfunctionMar 13, 2024Fracture; Appropriate Device Problem Term/Code Not Available; Fracture; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE QUESTIONNAIRE THE FOLLOWING INVESTIGATION AND STATEMENTS COULD BE MADE: · THE EVENT WAS OBSERVED DURING THAWING. · THE CUSTOMER DID USE A METAL CASSETTE FOR FREEZING AND FOR STORAGE. · A CONTROLLED RATE FREEZER WAS USED. · AN OVERWRAP BAG WAS NOT USED. · THE FILLING VOLUME PER BAG IS 120 ML (80 - 190 ML ARE RECOMMENDED). · THE FREEZING BAGS WERE STORED IN THE VAPOR PHASE OF LN2. ACCORDING TO THE PICTURES THE ISSUE CAN BE CONFIRMED. THE CRYOMACS FREEZING BAG IS CRACKED. THERE IS A LONG CRACK WHICH LEADS FROM THE BOTTOM OF THE BAG TO THE CENTRE OF THE BAG. THERE IS ANOTHER SMALL CRACK AT THE BOTTOM OF THE BAG. ACCORDING TO THE PICTURES THE CRACKED BAG IS PLACED IN A TRANSPARENT BAG. IT IS SUSPECTED, THAT IT WAS NOT FROZEN IN THE TRANSPARENT BAG. ACCORDING TO THE DESCRIPTION OF THE CUSTOMER IT CANNOT BE EXCLUDED THAT THE ISSUE IS CAUSED DUE TO SQUEEZING THROUGH THE FREEZER CASSETTE AT THE BOTTOM OF THE BAG. FOR THE CRYOMACS FREEZING BAG 750 BATCH 7230600613, WITH REGARD TO THE COMPLAINT, NO DEVIATION CONCERNING THE MANUFACTURING PROCESS OCCURRED. NO ANOMALIES OCCURRED DURING THE PROCESS. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS LOT WITH A INCIDENT RATE BELOW

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18895445 ↗
• MalfunctionFeb 15, 2024Fracture; Appropriate Device Problem Term/Code Not Available; Fracture; Appropriate Device Problem Term/Code Not Available

  THE CUSTOMER REPORTED LOSS OF MATERIAL AS THE TUBING BROKE AT JOINT BETWEEN THE BAG AND THE TUBING AFTER THAWING. THE CUSTOMER PROVIDED A QUESTIONNAIRE AND A PICTURE OF THE AFFECTED BAG. ACCORDING TO THE QUESTIONNAIRE THE FOLLOWING INVESTIGATION AND STATEMENTS COULD BE MADE: THE EVENT WAS OBSERVED DURING THAWING. THE CUSTOMER DID USE A METAL CASSETTE FOR FREEZING BUT NOT FOR STORAGE. A CONTROLLED RATE FREEZER WAS USED. AN OVERWRAP BAG WAS NOT USED FOR FREEZING. IT WAS ONLY USED DURING THAWING IN THE WATER BATH. THE FILLING VOLUME WAS 150 ML (80 - 190 ML ARE RECOMMENDED). THE FREEZING BAG WAS STORED IN THE VAPOR PHASE OF LN2. ACCORDING TO THE PICTURE THE EVA TUBE IS CRACKED OFF THE CRYOMACS FREEZING BAG AT THE CONNECTION FROM THE TUBE TO THE BAG. IT CAN BE SEEN THAT AN ADHESIVE LABEL WAS PUT ONTO THE SURFACE OF THE CRYOMACS FREEZING BAG. FOR THE CRYOMACS FREEZING BAG 750 BATCH 7221100100, WITH REGARD TO THE COMPLAINT, NO DEVIATION CONCERNING THE MANUFACTURING PROCESS OCCURRED. NO ANOMALIES OCCURRED DURING THE PROCESS. COMPLAINT RATE FOR THIS LOT AND THIS FAILURE IS BELOW (B)(4) . THE ISSUE IS LIKELY CAUSED BY PHYSICAL STRESS, E.G. MECHANICAL IMPACT IN COMBINATION WITH AN IMPROPER US

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18711207 ↗
• MalfunctionOct 11, 2023Fracture; Appropriate Device Problem Term/Code Not Available; Fracture; Appropriate Device Problem Term/Code Not Available

  THE CUSTOMER REPORTED A LEAKAGE OF A CRYOMACS FREEZING BAG 750 UPON THAWING. THE CELLS WERE NOT USED FOR TRANSPLANTATION BUT BACKUP MATERIAL WAS THAWED AND USED. THIS IS THE FIRST COMPLAINT FOR THIS LOT WITH A COMPLAINT RATE BELOW 0.01%. THE CUSTOMER PROVIDED A QUESTIONNAIRE AND PICTURES FOR THE INVESTIGATION. ACCORDING TO THE QUESTIONNAIRE THE FOLLOWING INVESTIGATION AND STATEMENTS COULD BE MADE: · THE EVENT WAS OBSERVED DURING THAWING. · THE CUSTOMER DID USE A METAL CASSETTE FOR FREEZING BUT NOT FOR STORAGE. · A CONTROLLED RATE FREEZER WAS USED. · AN OVERWRAP BAG WAS NOT USED FOR FREEZING. · THE FILLING VOLUME WAS 150 ML (80 - 190 ML ARE RECOMMENDED). · THE FREEZING BAG WAS STORED IN THE VAPOR PHASE OF LN2. ACCORDING TO THE PICTURES THE CRYOMACS FREEZING BAG IS CRACKED AT ONE OF THE EDGES. FOR THE CRYOMACS FREEZING BAG 750 BATCH 7221100100, WITH REGARD TO THE COMPLAINT, NO DEVIATION CONCERNING THE MANUFACTURING PROCESS OCCURRED. NO ANOMALIES OCCURRED DURING THE PROCESS. THE ISSUE IS LIKELY CAUSED BY PHYSICAL STRESS, E.G. MECHANICAL IMPACT IN COMBINATION WITH AN IMPROPER USER HANDLING DURING THE FREEZING PROCEDURE. THERE ARE SEVERAL DEVIATIONS FROM THE RECOMMENDED FREEZING PROCEDU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17912014 ↗
• MalfunctionJun 26, 2023Crack; Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available; Crack; Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available

  WHEN THAWING A CRYOMACS FREEZING BAG 750 THE CUSTOMER NOTICED THAT ONE OF THE BAGS WAS LEAKING BY ONE OF THE PORTS. THE BAG HAS BEEN DISCARDED. THE PATIENT WAS TREATED WITH BACKUP MATERIAL. (B)(4). FOR THE FREEZING BAG (B)(4) BATCH 7210800407, NO DEVIATION CONCERNING THE MANUFACTURING PROCESS OCCURRED. NO ANOMALIES OCCURRED DURING THE PROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17197341 ↗
• MalfunctionMay 5, 2023Fracture; Appropriate Device Problem Term/Code Not Available; Fracture; Appropriate Device Problem Term/Code Not Available

  DURING THE THAWING OF 2 BAGS OF CRYOPRESERVED HEMATOPOIETIC STEM CELLS FOR A PATIENT, PHARMACISTS FOUND THAT ONE OF THE 2 BAGS HAD COMPLETELY LEAKED. THE PRODUCT WAS THEREFORE TRANSFERRED TO AN OVERBAG. HOWEVER, DUE TO THE RISK OF CONTAMINATION OF THE CRACKED BAG THE GRAFT WAS DESTROYED. THE BACKUP BAG WAS ADMINISTERED TO THE PATIENT. THIS IS THE FIRST COMPLAINT FOR THIS LOT WITH A COMPLAINT RATE BELOW 0.01%. FOR THE CRYOMACS FREEZING BAG 750 BATCH 7220500802, WITH REGARD TO THE COMPLAINT, NO DEVIATION CONCERNING THE MANUFACTURING PROCESS OCCURRED. NO ANOMALIES OCCURRED DURING THE PROCESS. THE CUSTOMER PROVIDED PICTURES BUT NO FILLED IN QUESTIONAIRE WITH DETAILED INFORMATION. ACCORDING TO THE PICTURES THE ISSUE CAN BE CONFIRMED. THERE IS A CRACK AT THE EDGE AT THE BOTTOM OF THE BAG. ACCORDING TO THE DESCRIPTION IT IS SUSPECTED THAT NO OVERWRAP BAG WAS USED FOR FREEZING. DUE TO THE LACK OF INFORMATION A ROOT CAUSE CANNOT BE DETERMINED. THE ISSUE IS LIKELY CAUSED BY PHYSICAL STRESS, E.G. MECHANICAL IMPACT IN COMBINATION WITH AN IMPROPER USER HANDLING DURING THE FREEZING PROCEDURE. ACCORDING TO THE DESCRIPTION IT IS SUSPECTED THAT AN OVERWRAP BAG WAS NOT USED FOR FREEZING. THIS IS A D

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16874383 ↗
• MalfunctionJun 16, 2021Material Puncture/Hole; Material Puncture/Hole

  CUSTOMER USED THE CRYOMACS BAG AS A CELL COLLECTION BAG FOR THE CLINIMACS PLUS (VIA LEUR CONNECTION). DURING ELUTION, THE CUSTOMER NOTICED THAT THE TUBE (LIKELY THE EVA TUBING) STARTED TO LEAK, RESULTING IN THE LOSS OF PRODUCT. A PHOTO AND VIDEO ARE PROVIDED. THE AFFECTED TUBE WAS RETURNED. THE PATIENT DID NOT RECEIVE THE TREATMENT, THE PROCEDURE FOR THE TREATMENT IS A CLINIMACS CD34 + DEPLETION OF CD45RA AND ON DAY 7 CD56 INFUSION, THE CD34 AND THE CD45RA DEPLETION WENT WELL AND THE PATIENT GOT THE CELLS BUT IT WAS NOT POSSIBLE TO INFUSE THE CD56 CELLS WITH THE POTENTIAL RISK OF THE REACTIVATION OF HEPEX VI.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12009069 ↗
• MalfunctionMar 30, 2021Fracture; Fracture

  THE CUSTOMER DESCRIBED AND PROVIDED PHOTOS OF AN INCIDENT WHERE THE OUTER AND INNER CRYOPRESERVATION BAGS BROKE. THIS WAS NOTICED WHEN OPENING THE CASSETTE. CUSTOMER FOLLOWED INTERNAL SOP, ULTIMATELY TRANSFERRED THE REST OF THE CONTENTS INTO A NEW BAG UNDER A LAMINAR FLOW HOOD. INITIAL MATERIAL WAS 150 ML AND 98 MLS WERE SAVED.

  Patient problems: Insufficient Information

  MAUDE report 11588049 ↗
• MalfunctionFeb 3, 2021Fluid/Blood Leak; Fluid/Blood Leak

  FOR CRYOMACS FREEZING BAG 750 THE CUSTOMER OBSERVED THAT IN THE LOT 7200700537 THERE IS A SMALL "POCKET" IN THE UPPER CORNER OF THE BAG AND THE CELL SUSPENSION IS ABLE TO ACCESS THAT POCKET. AT LEAST IN ONE OF THE BAGS THERE WAS ALSO A HOLE AT THE END OF THE POCKET, SO CELL SUSPENSION WAS ABLE TO LEAK OUT FROM THE BAG AND THE SUSPENSION WAS SUBJECTED TO OUTSIDE CONTAMINATION AS WELL. THE CUSTOMER PROVIDED PICTURES OF THE AFFECTED BAG. THE ISSUE DESCRIBED FOR THIS SINGLE BAG, WHERE AN OPEN CHANNEL TO THE OUTSIDE OCCURED, COULD POTENTIALLY LEAD TO THE LOSS OF A SMALL AMOUNT OF MATERIAL AND CONTAMINATION. THE CUSTOMER DESCRIBED ANOTHER CASE, WHERE CELL SUSPENSION LEAKED INTO THE POCKET BUT NOT TO THE OUTSIDE. THIS IS NOT CONSIDERED A REPORTABLE EVENT, BECAUSE NO LOSS OF CELLS OR CONTAMINATION IS POSSIBLE. THE CUSTOMER ALSO DESCRIBES BAGS WITH POCKETS. THE FORMATION OF POCKETS OCCURS IN REGULAR PRODUCTS AND IS AT THIS TIME POINT NO INDICATION OF A LEAKAGE PROBLEM. THE BAGS WERE RETRIEVED FROM THE CUSTOMER, INVESTIGATED AND FOUND TO HAVE NO FAIL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11271970 ↗
• MalfunctionApr 15, 2020Fracture; Fracture

  THE CUSTOMER REPORTED A BREAKAGE OF A CRYOMACS BAG DURING THAWING. THE PATIENT WAS TREATED WITH BACKUP MATERIAL. THE CUSTOMER SENT PICTURES AND A FILLED QUESTIONNAIRE FOR A MORE DETAILED INVESTIGATION. THE INVESTIGATION OF THE PICTURES SHOWED A CRACK IN THE BAG. ACCORDING TO THE QUESTIONNAIRE THERE WERE DEVIATIONS FROM THE RECOMMENDED FREEZING PROCEDURE FOR HANDLING THE BAG. THE OVERWRAP BAG WAS NOT EVACUATED. IT HAS TO BE NOTED, THAT ALL AIR HAS TO BE REMOVED FROM THE BAG AND THE OVERWRAP BAG. AIR IN EITHER BAG HAS TO BE ABSOLUTELY AVOIDED AS IT EXPANDS DURING THAWING AND THEREBY CAN CAUSE CRACKS. EQUALLY CRITICAL IS THAT THE BAG WAS STORED IN THE LIQUID PHASE AND NOT PLACED FOR AT LEAST 4 HOURS IN THE VAPOR PHASE PRIOR TO REMOVAL FROM THE STORAGE TANK. BOTH STEPS ARE DESCRIBED IN THE INSTRUCTIONS FOR USE. THE OVERWRAP BAG IS USED TO RESCUE CELLS FROM A BROKEN BAG IF NECESSARY. IT IS LIKELY THAT THIS DID NOT HAPPEN AS ENOUGH BACKUP MATERIAL WAS AVAILABLE. THE INCIDENT RATE FOR THE LOT USED BY THE CUSTOMER IS LOW WITH (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9962147 ↗
• MalfunctionJan 8, 2020Fracture; Fracture

  THE CUSTOMER OBSERVED REPEATED BAG BREAKAGE ISSUE OF CRYOMACS FREEZING BAG PART NO. 200-074-403, LOT NO. 6180601002. THIS LOT WAS USED IN FOUR INDEPENDENT PRODUCTIONS AND 8 BREAKAGE HAVE BEEN OBSERVED SO FAR. 6 OUT OF 8 BREAKAGE OCCURRED AT TUBING AREA. THIS IS THE SECOND COMPLAINT, RELATED TO BREAKAGE FOR THIS LOT WITH A INCIDENT RATE OF (B)(4) ((B)(4) BAGS IN TOTAL). THE CUSTOMER STATED THAT NO OVERWRAP BAG WAS USED. THE OVERWRAP BAG RAISES SAFETY AND STABILIZES THE BAG. IT HELPS AVOID BREAKAGES AND ALLOWS TO RESCUE CELLS IN CASE A BREAKAGE OCCURS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9563317 ↗
• MalfunctionNov 25, 2019Fracture; Fracture

  RIGHT AFTER THE THAWING OF THE CRYOMACS FREEZING BAG CONTAINING STEM CELLS, THE OPERATOR NOTICED A LEAK AT THE CONNECTION BETWEEN TUBE AND BAG. THE PATIENT WAS TREATED WITH BACKUP MATERIAL. THE CRYOMACS FREEZING BAG PROBABLY BROKE DUE TO MECHANICAL STRESS DURING HANDLING. THE OVERWRAP BAG PROVIDED WITH THE FREEZING BAG WAS NOT USED FOR STORAGE TO STABILIZE THE BAG AND IF NECESSARY RESCUE THE CELLS. NO METAL CASSETTE WAS USED FOR STORAGE. BOTH STEPS ARE DESCRIBED IN THE PRODUCT INFORMATION SHEET. THE COMPLAINT DATABASE WAS ANALYSED FOR SIMILAR INCIDENTS WITH THIS LOT. THIS WAS FOUND TO BE THE SECOND COMPLAINT WITH A BREAKAGE OF THE BAG FOR THIS LOT. FOR THIS LOT SO FAR (B)(4) BOXES WITH (B)(4) BAGS HAVE BEEN SOLD. THE COMPLAINT RATE IS (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9370529 ↗
• MalfunctionOct 9, 2019Fracture; Fracture

  THE CUSTOMER COMPLAINED TWO CRYOMACS FREEZING BAGS THAT BROKE DURING THAWING. THE CUSTOMER DID NOT USE A OVERWRAP BAG OR A FREEZING CASETTE. THE FREEZING PROCEDURE WITH A CONTROLLED RATE FREEZER WAS NOT VALIDATED BY THE CUSTOMER FOR THIS TYPE OF BAGS. THE BAG WAS STORED WITHOUT OVERWRAP BAG AND METAL CASETTE. BOTH MEASURES RAISE SAFETY OF THE CRYOMACS BAG. FOR BOTH LOTS THE COMPLAINT RATE REGARDING BREAKAGE IS BELOW 0.01%.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9172180 ↗