MEDRAD Mark V Provis Foot Switch with Cable KMA 562-IRecalls & reported problems
Bayer Medical Care Inc. · ASSY, CABLE, FOOT SWITCH, UDI, BATCH (86024942)(25 ft.) · Class 2
Data updated Oct 18, 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 00616258020808), received between Jul 23, 2020 and Jul 23, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fitting Problem” (1 report).
1 other recall cover devices cleared under the same FDA submission (K903390); they may or may not involve this specific model.
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
Device problems
- Fitting Problem1
- Gas/Air Leak1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 23, 2020Fitting Problem; Gas/Air Leak
RADIOLOGY STAFF DISCOVERED THERE WAS NOT AN AIRTIGHT CONNECTION BETWEEN THE TIP OF THE CONTRAST SYRINGE WITH THE TUBING, AND UNDER ASPIRATION THERE WAS A SEAL DISTALLY BUT PROXIMALLY THERE WAS NOT A SEAL. AFTER INVESTIGATION A LEAK WAS FOUND WHICH ALLOWED AIR INTO THE TUBING. THE LEAK IS DUE TO THE SYRINGE AND CONTRAST TUBING NOT ADEQUATELY FITTING. AIR WAS INJECTED INTO THE PATIENT AND WAS SEEN ON IMAGING. REPEAT IMAGING SHOWED THAT THE AIR WAS QUICKLY RE-ABSORBED AND THE PATIENT HAD NO ADVERSE EFFECTS. THE PATIENT WAS MONITORED FOR A FEW HOURS POST PROCEDURE WITH NO COMPLICATIONS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10312083 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K903390. One submission often covers many models, so check the product and lot details in each record.
- Z-0745-2019 · Dec 14, 2018 · TerminatedMAVIG Portegra or Portegra2 Overhead Counterpoise System (OCS) used in conjunction with the Medrad Stellant CT Injection System (Certegra Workstation), Medrad Mark 7 Arterion" Inje
Other Injector And Syringe, Angiographic devices
- Monarch® 00884450298022Merit Medical Systems, Inc. · INJECTOR AND SYRINGE, ANGIOGRAPHIC2 recalls37 reports
- Blue Diamond™ 00884450498743Merit Medical Systems, Inc. · Injector and syringe, angiographic2 recalls0 reports
- Monarch® 00884450298053Merit Medical Systems, Inc. · INJECTOR AND SYRINGE, ANGIOGRAPHIC2 recalls0 reports
- Monarch® 00884450298060Merit Medical Systems, Inc. · INJECTOR AND SYRINGE, ANGIOGRAPHIC2 recalls0 reports
- NAMIC 80085007Medline Industries, Inc. · Injector and syringe, angiographic1 recall36 reports
- NA 622510B. Braun Medical Inc. · INJECTOR AND SYRINGE, ANGIOGRAPHIC85 reports
- NAMIC 80087007Medline Industries, Inc. · Injector and syringe, angiographic1 recall20 reports
- Blue Diamond™ 00884450381168Merit Medical Systems, Inc. · INJECTOR AND SYRINGE, ANGIOGRAPHIC1 recall6 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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