NAMIC 60160641Recalls & reported problems
Medline Industries, Inc. · MTS LEFT HEART KIT-BAYSHORE MED CENTER · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10193489048865), received between Sep 29, 2026 and Sep 29, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Integrity Problem” (1 report).
2 FDA recall records name this device's identifier, 2 still open.
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.
Reports received per month
Recalls naming this device
- Mar 24, 2026Open, Classified
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Z-2145-2026 · Root cause: Under Investigation by firm · FDA record ↗
- Feb 27, 2026Open, Classified
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Z-1718-2026 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Material Integrity Problem1
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.
MalfunctionSep 29, 2026Material Integrity Problem
It was reported that "We had this wire come from one of our cath packs just like this...it had NOT been inserted into a patient or anything but was very close to."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932080 ↗
Other Cardiovascular procedure kit devices
- Medline Industries, Inc. CDS840396YMedline Industries, Inc. · Cardiovascular procedure kit6 recalls0 reports
- Medline Industries, Inc. CDS983513FMedline Industries, Inc. · Cardiovascular procedure kit6 recalls0 reports
- Medline Industries, Inc. CDS984355GMedline Industries, Inc. · Cardiovascular procedure kit5 recalls0 reports
- Medline Industries, Inc. CDS840396XMedline Industries, Inc. · Cardiovascular procedure kit5 recalls0 reports
- Medline Industries, Inc. DYNJ51038RMedline Industries, Inc. · Cardiovascular procedure kit4 recalls2 reports
- Medline Industries, Inc. CDS983773JMedline Industries, Inc. · Cardiovascular procedure kit4 recalls0 reports
- Medline Industries, Inc. DYNJ42921GMedline Industries, Inc. · Cardiovascular procedure kit4 recalls0 reports
- Medline Industries, Inc. DYNJ50478FMedline Industries, Inc. · Cardiovascular procedure kit4 recalls0 reports
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 · each recall links to the FDA recall notice
- 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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