ACS SACL75AMRecalls & reported problems
American Contract Systems, Inc. · CATH LAB · Class 2
Data updated Oct 16, 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 00191072178404), received between Mar 4, 2025 and Mar 4, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Misassembled During Manufacturing /Shipping” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device Misassembled During Manufacturing /Shipping1
- Product Quality Problem1
Patient problems
- Abrasion1
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 4, 2025Product Quality Problem; Device Misassembled During Manufacturing /Shipping; Product Quality Problem; Device Misassembled During Manufacturing /Shipping
THE CUSTOMER REPORTED AN ISSUE WITH THE SYRINGE INSIDE THE KIT. THE EDGE OF SYRINGE PENETRATED THE PHYSICIAN'S GLOVE AND SKIN. THIS INCIDENT CONTAMINATED THE STERILE FIELD DUE TO THE GLOVE BREACH. INCIDENT OCCURRED DURING A CARDIAC CATH PROCEDURE.
Patient problems: Abrasion; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 21514314 ↗
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- Medline Industries, Inc. ECVC5200Centurion Medical Products Corporation · Cardiac catheterization kit3 recalls0 reports
- Medline Industries, Inc. DYNJ0578916XMedline Industries, Inc. · Cardiac catheterization kit3 recalls0 reports
- Medline Industries, Inc. DYNJ83089Medline Industries, Inc. · Cardiac catheterization kit3 recalls0 reports
- Medline Industries, Inc. ECVC6845Centurion Medical Products Corporation · Cardiac catheterization kit3 recalls0 reports
- Medline Industries, Inc. DYNJ44850JMedline Industries, Inc. · Cardiac catheterization kit3 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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