CRW® HRAIMRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10381780252283), received between Jul 7, 2022 and Jul 7, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Output Problem” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K944463); 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 16, 2026.

Most reported problems

Recent adverse event reports

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

• InjuryJul 7, 2022Output Problem; Output Problem

  THIS IS 1 OF 2 REPORTS LINKED TO MFG REPORT NUMBERS: 3014334038-2022-00051. SAME PATIENT, SAME EVENT, DIFFERENT PRODUCTS. A FACILITY REPORTED A CERELINK SENSOR WAS PLACED IN THE OPERATING ROOM (OR) AND WAS WORKING FINE. THE PATIENT WAS DISCONNECTED FROM THE MONITOR, PLACED ON A TRANSPORT BED, BROUGHT TO POST ANESTHESIA CARE UNIT (PACU). IN THE PACU IT REPEATEDLY GOT A SENSOR/CABLE FAILURE ERROR. THEY REPLACED THE CABLE AND MONITOR FOR THREE TIMES. THEY KEPT THE SENSOR IN THE PATIENT OVERNIGHT. IT WAS A TUNNELED BASIC SENSOR. THEY TRIED THE CERELINK OVERNIGHT WITH NO SUCCESS. TROUBLESHOOTING WAS DONE IN THE MORNING AND TRIED IT IN AN ICPX WITH A REFERENCE CODE OF 500 TO SEE IF THE SENSOR WOULD WORK, HOWEVER, SENSOR WAS NOT ACKNOWLEDGED. THE PATIENT WENT BACK TO THE OR, BACK UNDER ANESTHESIA, THE SENSOR WAS REMOVED AND WAS NOT REPLACED.

  Patient problems: Failure of Implant

  MAUDE report 14946034 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K944463. One submission often covers many models, so check the product and lot details in each record.

• Z-0025-2016 · Aug 21, 2015 · Terminated
  Universal Compact Head Ring Adapter Plate (UCHRAP), a component of the Universal Compact Head Ring Adapter, UCHRA. The UCHRA is a component of the Integra CRW Precision Arc Stereo
• Z-2429-2012 · Aug 9, 2012 · Terminated
  Integra HRAIM Head Ring Assembly with Intubation Mounts The CRW stereotactic system is used in conjunction with the HRAIM head ring is a target-centered system that can be config
• Z-2428-2012 · Aug 9, 2012 · Terminated
  Integra CRW Precision Arc (CRWPRECISE), CRW Arc System (CRWASL), HRAIM Head Ring Assembly with Intubation Mounts The CRW stereotactic system is used in conjunction with the HRAIM
• Z-1400-2011 · Jan 12, 2011 · Terminated
  Integra Radionics HRAIM Intubation Head Ring Assembly Ref: HRAIM Head Rings serve as the general stereotactic treatment platform. Head Rings are used to provide a reference frame f