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CATALYST NON-EXPANDABLE BED ASM100113Recalls & reported problems

Kreg Medical Inc. · Hospital Bed with Standing Frame · Class 2

Adverse event reports
4
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00850520008143), received between May 7, 2022 and Apr 17, 2026 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Off-Label Use” (2 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 1 reportsMar 2026: 0 reportsApr 2026: 1 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Off-Label Use2
  • Adverse Event Without Identified Device or Use Problem1
  • Device Handling Problem1
  • Patient Device Interaction Problem1

Patient problems

  • Bone Fracture(s)1
  • Brain Injury1
  • Crushing Injury1
  • Deformity/ Disfigurement1
  • Unspecified Tissue Injury1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • InjuryApr 17, 2026Off-Label Use

    ON (B)(6) 2026, AT APPROXIMATELY 9:30 AM, A PATIENT WAS FOUND ON THE FLOOR BESIDE THE CATALYST® BED AT EVANSTON HOSPITAL. THE PATIENT SUSTAINED A MANDIBULAR FRACTURE BECAUSE OF THE FALL. AT THE TIME OF THE DISCOVERY, THE BED EXIT ALARM INDICATOR LIGHT WAS OFF, AND NO AUDIBLE ALARM HAD BEEN REPORTED BY NURSING STAFF.

    Patient problems: Bone Fracture(s)

    MAUDE report 24915571 ↗
  • InjuryFeb 12, 2026Off-Label Use

    AT APPROXIMATELY 18:30 ON (B)(6) 2025, A PATIENT SLID OUT OF THE RIGHT SIDE OF A CATALYST® NON-BARIATRIC BED WHILE UNATTENDED. THE RIGHT HEAD RAIL WAS PARTIALLY DOWN, THE NURSE CALL CABLE WAS UNPLUGGED, AND THE BED-EXIT ALARM, THOUGH REPORTED AS ON DID NOT SOUND UNTIL AFTER THE PATIENT WAS REPOSITIONED. THE PATIENT SUSTAINED A HEAD INJURY THAT REQUIRED CT IMAGING, WHICH REVEALED A SMALL BRAIN BLEED. THE PATIENT REMAINED STABLE AND DID NOT REQUIRE ICU TRANSFER.

    Patient problems: Brain Injury

    MAUDE report 24326959 ↗
  • MalfunctionJun 3, 2022Adverse Event Without Identified Device or Use Problem

    AT APPROXIMATELY 0730, EMPLOYEE 1 AND EMPLOYEE 2 WERE TRANSPORTING A PATIENT FROM THE ICU TO THE DIALYSIS UNIT. ALONG THE ROUTE FROM THE ICU TO THE DIALYSIS UNIT, THE EMPLOYEES ENCOUNTERED CONSTRUCTION BARRIER THAT NARROWED THE PASSAGEWAY OF THE HALLWAY. AS THEY WERE CROSSING THE NARROWED PASSAGEWAY, EMPLOYEE 1'S RIGHT HAND WAS CAUGHT BETWEEN A "STOP THE BLEED" KIT MOUNTED ON THE WALL OF THE HALLWAY AND THE BED'S FOOT BOARD. EMPLOYEE 1'S RIGHT FINGERTIP WAS AVULSED IN THE INCIDENT. THE CATALYST BED FOOTBOARD HAS HAND HOLES AT THE 3 AND 9 O'CLOCK POSITIONS AND EMPLOYEE 1 HAD HER HANDS IN THE BED'S HAND HOLES AT THE TIME OF THE INCIDENT. EMPLOYEE 1 WAS POSITIONED WITH HER BACK TOWARD THE DIRECTION OF TRAVEL. EMPLOYEE 2 SHOUTED A WARNING, BUT THIS WAS TOO LATE TO ALLOW TIME FOR EMPLOYEE 1 TO REACT TO STEER OR BRAKE THE BED. EMPLOYEE 1 WAS AT THE HEAD OF THE BED, ALSO PUSHING AN IV POLE. THE BED AND PATIENT WEIGHED APPROXIMATELY 575 KG. BOTH EMPLOYEES NOTED THAT THE BED TRACKED IN A STRAIGHT LINE WITHOUT ISSUE BUT WAS DIFFICULT TO STEER OR TURN. AT THE TIME OF THE INCIDENT, THE BED WAS TRAVELING IN A STRAIGHT LINE. THE MASS OF THE BED AND PATIENT (MOMENTUM) AND THE EMPLOYEE'S BACK POSI

    Patient problems: Unspecified Tissue Injury

    MAUDE report 14591565 ↗
  • InjuryMay 7, 2022Device Handling Problem; Patient Device Interaction Problem; Device Handling Problem; Patient Device Interaction Problem

    ON (B)(6) 2022 AT APPROXIMATELY 5:00 PM, IT WAS REPORTED DIRECTLY TO KREG SALES REPRESENTATIVE VIA A PHONE CALL FROM THE FACILITY NURSE MANAGER THAT AN INCIDENT HAD OCCURRED WITH ONE OF THE KREG BEDS. THE NURSE MANAGER PROVIDED A BASIC INITIAL VERBAL STATEMENT OF THE INCIDENT. SHE REPORTED THAT A NURSE TECHNICIAN HAD A FINGER AMPUTATED AFTER AN INCIDENT RELATED TO HER INVOLVEMENT IN TRANSPORTING A PATIENT ON A KREG BED TO DIALYSIS. THE INITIAL REPORT STATED THE PATIENT CARE TECHNICIAN WAS PULLING THE BED AND A NURSE WAS PUSHING THE BED WHEN IT HIT A BOX ATTACHED TO THE WALL, NO FURTHER DETAILS WERE PROVIDED AT THE TIME.

    Patient problems: Crushing Injury; Deformity/ Disfigurement

    MAUDE report 14326510 ↗

Other Bed, Ac-Powered Adjustable Hospital devices

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