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Kendall SCD 29525Recalls & reported problems

Cardinal Health, Inc. · 700 Sequential Compression System · Class 2

Quick summary

This is a Cardinal Health Kendall Sequential Compression System sleeve, a compressible limb sleeve used to reduce swelling in a patient's arm or leg. The 56 reports mostly describe the sleeve and its power cord burning or sparking when plugged into a wall outlet, plus cuts and splits in the material and temperature problems. All 56 reports are malfunctions, with no deaths and no injuries. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
56
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 10884521129566), received between Jun 6, 2017 and Mar 29, 2023 — classified as 56 malfunctions.

The most frequently reported specific device problem is “Cut In Material” (15 reports).

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

  • Cut In Material15
  • Temperature Problem15
  • Split14
  • Power Problem5
  • Appropriate Device Problem Term/Code Not Available3
  • Fire2
  • Sparking2
  • Break1

Patient problems

  • No Patient Involvement26
  • No Information18
  • No Clinical Signs, Symptoms or Conditions7
  • No Consequences Or Impact To Patient4
  • No Known Impact Or Consequence To Patient3

Recent adverse event reports

The 25 most recent of 56 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 29, 2023Fire; Fire

    THE CUSTOMER REPORTED THAT THE DEVICE AND/OR POWER CORD CAUGHT ON FIRE ONCE IT WAS PLUGGED INTO THE AC WALL UNIT. WHEN THE STAFF MEMBER PLUGGED THE DEVICE INTO AC POWER, THE POSITIVE VOLTAGE WAS SHORTED TO GROUND DUE TO THE INTERNAL FAILURE OF THE AC PLUG AND WIRING. THERE WAS A SPARK AND FLAMES THAT APPEARED AT THE PLUG AND WALL OUTLET. THEY PLANNED ON CHANGING THE AC POWER CORD AND TESTING THE DEVICE FOR FUNCTION. THE STAFF MEMBER WAS NOT HARMED. THE PUMP DID NOT CATCH ON FIRE. THERE WAS NO VISIBLE DAMAGE ON THE PUMP.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16637176 ↗
  • MalfunctionMay 10, 2022Sparking; Sparking

    THE CUSTOMER REPORTED THAT THERE WAS A SPARK WHEN THE DEVICE WAS PLUGGED IN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14349178 ↗
  • MalfunctionJun 26, 2021Sparking; Sparking

    THE CUSTOMER REPORTED THAT THE DEVICE SPARKS WHEN PLUGGED IN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12072927 ↗
  • MalfunctionJun 26, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

    THE CUSTOMER REPORTED THAT THE POWER CORD BURNED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12072920 ↗
  • MalfunctionJun 26, 2021Temperature Problem; Temperature Problem

    THE CUSTOMER REPORTED THAT THE DEVICE POWER CORD IS BURNT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12072892 ↗
  • MalfunctionJun 26, 2021Temperature Problem; Temperature Problem

    THE CUSTOMER REPORTED THAT THE DEVICE HAD A BURNT CORD AND ELECTRICAL SMELL.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12072756 ↗
  • MalfunctionMay 21, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

    THE CUSTOMER REPORTED THAT THE SIDE OF THE CORD WAS BURNT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11866512 ↗
  • MalfunctionJul 8, 2019Fire; Fire

    THE CUSTOMER REPORTS UNIT CAUGHT FIRE. THERE WAS NO HARM TO THE PATIENT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8768078 ↗
  • MalfunctionAug 8, 2018Break; Power Problem; Power Problem

    THE CUSTOMER STATES THE UNIT HAS PHYSICAL DAMAGE. UPON TRIAGE, THE FOLLOWING ISSUE WAS FOUND: A DAMAGED POWER CORD WITH EXPOSED COPPER WIRING.

    Patient problems: No Consequences Or Impact To Patient; No Information

    MAUDE report 7761650 ↗
  • MalfunctionJul 10, 2018Material Protrusion/Extrusion; Power Problem; Power Problem

    THE CUSTOMER STATES THAT THE UNIT HAS A DISPLAY ISSUE. UPON TRIAGE IT WAS NOTED THAT THE POWER CORD HAS EXPOSED COPPER WIRES.

    Patient problems: No Information; No Patient Involvement

    MAUDE report 7674294 ↗
  • MalfunctionJun 28, 2018Cut In Material; Cut In Material

    THE CUSTOMER REPORTS THE UNIT HAD A CUT IN THE POWER CORD EXPOSING COPPER WIRES.

    Patient problems: No Patient Involvement

    MAUDE report 7645752 ↗
  • MalfunctionJun 28, 2018Cut In Material; Cut In Material

    THE CUSTOMER REPORTS THE UNIT HAD A CUT IN THE POWER CORD EXPOSING COPPER WIRES.

    Patient problems: No Patient Involvement

    MAUDE report 7645371 ↗
  • MalfunctionJun 18, 2018Cut In Material; Split; Cut In Material; Split

    THE CUSTOMER REPORTS THE PUMP HAS A DAMAGED CASE. UPON TRIAGE THE SERVICE TECH FOUND THE PUMP TO HAVE A DAMAGED POWER CORD WITH EXPOSED COPPER WIRES.

    Patient problems: No Patient Involvement

    MAUDE report 7611672 ↗
  • MalfunctionJun 4, 2018Cut In Material; Cut In Material

    UPON TRIAGE, THE TECHNICIAN FOUND THAT THE POWER CORD WAS DAMAGED AND COPPER WIRING WAS EXPOSED.

    Patient problems: No Patient Involvement

    MAUDE report 7564694 ↗
  • MalfunctionMay 11, 2018Split; Split

    THE CUSTOMER STATES A DAMAGED CASE. UPON INSPECTION, THE FOLLOWING ISSUE WAS FOUND A DAMAGED POWER CORD WITH EXPOSED COPPER. NO PATIENT INVOLVED OR HARMED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7506191 ↗
  • MalfunctionMay 8, 2018Temperature Problem; Temperature Problem

    THE CUSTOMER STATED THAT THE UNIT HAS A THERMAL ISSUE DUE TO IT SMOKING AND HOT. NO PATIENT INVOLVED OR HARMED.

    Patient problems: No Patient Involvement

    MAUDE report 7494542 ↗
  • MalfunctionMay 5, 2018Split; Split

    THE CUSTOMER STATES AN ERROR OCCURRED. UPON TRIAGE SERVICE FOUND THE POWER CORD TO HAVE EXPOSED COPPER WIRES.

    Patient problems: No Patient Involvement

    MAUDE report 7489346 ↗
  • MalfunctionMay 2, 2018Temperature Problem; Temperature Problem

    UPON TRIAGE IT WAS NOTED THAT THE CONTROL BOARD IS OVERHEATING.

    Patient problems: No Patient Involvement

    MAUDE report 7480241 ↗
  • MalfunctionApr 27, 2018Temperature Problem; Temperature Problem

    THE CUSTOMER REPORTS THE PUMP OVERHEATS.

    Patient problems: No Information

    MAUDE report 7467916 ↗
  • MalfunctionApr 9, 2018Cut In Material; Cut In Material

    THE CUSTOMER REPORTS THE PUMP HAS A DAMAGED BED HOOK AND THE POWER CORD IS DAMAGED WITH EXPOSED COPPER.

    Patient problems: No Patient Involvement

    MAUDE report 7409829 ↗
  • MalfunctionMar 19, 2018Cut In Material; Cut In Material

    THE CUSTOMER STATED THAT THE UNIT HAD NO POWER. UPON TRIAGE THE POWER CORD WAS FOUND DAMAGED WITH EXPOSED COPPER WIRES.

    Patient problems: No Patient Involvement

    MAUDE report 7349379 ↗
  • MalfunctionMar 9, 2018Cut In Material; Cut In Material

    UPON TRIAGE, THE FOLLOWING ISSUE WAS FOUND: A DAMAGED POWER CORD WITH EXPOSED COPPER WIRING.

    Patient problems: No Patient Involvement

    MAUDE report 7328297 ↗
  • MalfunctionMar 9, 2018Cut In Material; Cut In Material

    THE CUSTOMER REPORTS THE PUMP HAS INTERNAL NOISE. UPON TRIAGE, THE FOLLOWING ISSUE WAS FOUND: A DAMAGED POWER CORD WITH EXPOSED COPPER WIRING.

    Patient problems: No Patient Involvement

    MAUDE report 7328177 ↗
  • MalfunctionMar 9, 2018Cut In Material; Cut In Material

    UPON TRIAGE, THE FOLLOWING ISSUE WAS FOUND: A DAMAGED POWER CORD WITH EXPOSED COPPER.

    Patient problems: No Patient Involvement

    MAUDE report 7327919 ↗
  • MalfunctionMar 9, 2018Cut In Material; Cut In Material

    THE CUSTOMER REPORTS THE PUMP IS NOT WORKING. UPON TRIAGE THE SERVICE TECH FOUND THE PUMP TO HAVE A POWER CORD WITH EXPOSED COPPER.

    Patient problems: No Patient Involvement

    MAUDE report 7327858 ↗

Other Sleeve, Limb, Compressible devices

All Sleeve, Limb, Compressible devices →

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