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Gen2 System Kit 1Recalls & reported problems

Coapt LLC · The Gen2 System Kit is a medical device kit that contains the Coapt COMPLETE CONTROL System Gen2 (DI=B618N1) and the Coapt Dome Electrodes (DI=B618E0). · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI B618P1), received between Sep 19, 2023 and Sep 19, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Ambient Temperature Problem” (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

  • Ambient Temperature Problem1
  • Temperature Problem1

Patient problems

  • Skin Inflammation/ Irritation1
  • Superficial (First Degree) Burn1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjurySep 19, 2023Ambient Temperature Problem; Temperature Problem; Ambient Temperature Problem; Temperature Problem

    PATIENT THERMAL BURN ON RESIDUAL LIMB DURING PROSTHESIS WEAR. AFTER ABOUT 8 HOURS OF CONTINUED USE, PATIENT DOFFED HIS PROSTHETIC DEVICE AND NOTICED THERMAL BLISTERS ON HIS RESIDUAL LIMB. UPON FURTHER INSPECTION, HE FOUND CONSISTENT HOT SPOTS WITH WHERE OTHER SENSORS WERE ON THE LEFT SIDE OF HIS LIMB. HE ALSO NOTICED THAT THE BATTERY ON THAT SIDE SEEMED TO HAVE HEATED UP OR INDENTED THE SOCKET. PATIENT DID NOT FEEL ANY SENSATION OF HEAT, AND HAD HIS PROSTHETIC IN "FREEZE MODE". PATIENT CONFIRMS HE WAS NOT IN DIRECT HEAT WHILE WEARING THE PRODUCT, INDICATING THAT ENVIRONMENTAL HEAT EXPOSURE WAS NOT A LIKELY CAUSE. PATIENT RETURNED THE PROSTHETIC ARM SYSTEM TO HIS PROSTHETIST (CLINICIAN) WHO SUBSEQUENTLY SEND IT TO THE PROSTHETIC HAND AND BATTERY MANUFACTURER, PSYONIC (SAN DIEGO, CA, HTTPS://WWW.PSYONIC.IO/) FOR DIAGNOSIS AND INSPECTION. THE INVESTIGATION BY THE PROSTHETIC HAND AND BATTERY MANUFACTURER, PSYONIC (SAN DIEGO, CA, HTTPS://WWW.PSYONIC.IO/) DETERMINED THAT A PSYONIC BATTERY UNIT INSTALLED INSIDE THE PROSTHETIC ARM SYSTEM BECAME BENT, WHICH CAUSED THIS BATTERY DAMAGE; INTERNAL DAMAGE WITHIN THE BATTERY UNIT RESULTING IN THE BATTERY CELL OVERHEATING. PSYONIC'S INVESTIGATION

    Patient problems: Skin Inflammation/ Irritation; Superficial (First Degree) Burn

    MAUDE report 17772547 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.