NA CB1V97R1Recalls & reported problems
Medtronic, Inc. · CUSTOM PACK CB1V97R1 CCS/B/BP · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169878976), received between Jun 20, 2023 and Jun 20, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).
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
Device problems
- Fluid/Blood Leak1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 20, 2023Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation
MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE DURING PRIMING, THE CUSTOMER REPORTED ONE OF THE CUSTOM PACK'S SAMPLE LINE PORTS LEAKED AND THEY NOTICED IT WAS BROKEN. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT SO NO ADVERSE EFFECT OCCURRED. ADDITIONAL INFORMATION: THE PERFUSIONIST PROVIDED THE SAMPLE LINE FROM THE PACK, THE REMAINDER OF THE PACK WAS DISCARDED. THE SAME LEAK DID NOT OCCUR IN OTHER PACKS. THE LEAK ORIGINATED FROM THE COMPONENT. NO VISIBLE AIR WAS NOTICED IN THE SYSTEM/TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17162683 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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