restor3d Reusable Inserter 5000-0101Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00840097502083), received between Sep 2, 2021 and Jul 12, 2022 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Failure to Pump” (5 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 12, 2022Insufficient Cooling; Defective Component; Insufficient Cooling; Defective Component

  IT WAS REPORTED THAT THE ARCTIC SUN DEVICE WAS NOT COOLING THE WATER. CHILLER TEMPERATURE (T4) DID NOT COOL. PER FOLLOW UP INFORMATION RECEIVED ON 24JUN2022, THERE WAS NO PATIENT INVOLVED, SYSTEM WAS NOT USED ON THE PATIENT. AND THE CHILLER ASSEMBLY WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14989028 ↗
• MalfunctionMay 26, 2022Failure to Pump; Failure to Calibrate; Failure to Pump; Failure to Calibrate

  IT WAS REPORTED THAT THE ARCTIC SUN DEVICE WAS NOT ABLE TO MAINTAIN A CONSTANT TEMPERATURE DURING CALIBRATION. PER FOLLOW UP INFORMATION RECEIVED ON 20MAY2022, THE ISSUE WAS RESOLVED BY REPLACING THE CIRCULATION PUMP BY A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14503662 ↗
• MalfunctionMay 21, 2022Computer Software Problem; Computer Software Problem

  IT WAS REPORTED THAT THE ARCTIC SUN DEVICE RETURNED TO THE STATE NORMOTHERMIA. PER FOLLOW-UP INFORMATION RECEIVED VIA IBC ON 19SEP2021, THE DEVICE DOES NOT REVERT TO NORMOTHERM STATUS AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14466545 ↗
• MalfunctionApr 9, 2022Failure to Pump; Pumping Problem; Failure to Pump; Pumping Problem

  IT WAS REPORTED THAT THE ARCTIC SUN DEVICE CONSOLE WAS LEAKING THROUGH THE WATER SUPPLY CABLES. PER SAMPLE EVALUATION, IT WAS REPORTED THAT THE MIXING PUMP WAS FAULTY, AND IT WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14067984 ↗
• MalfunctionMar 31, 2022Circuit Failure; Circuit Failure

  IT WAS REPORTED THAT THE ARCTIC SUN DEVICE RECEIVED AN ERROR CODE 77 (NON-RECOVERABLE SYSTEM ERROR) AND TEMPERATURE PROBE ISSUE. THE PATIENT WAS SWITCHED TO A DIFFERENT DEVICE. PER FOLLOW UP INFORMATION RECEIVED ON 11MAR2022, MANIFOLD ASSEMBLY WOULD BE REPLACED TO FIX THE ISSUE. PER FOLLOW UP INFORMATION RECEIVED ON 15MAR2022, THE PATIENT CONTINUED THERAPY ON THE SAME DEVICE. THEY HAD TEMPERATURE PROBE ISSUE. PER FOLLOW UP INFORMATION RECEIVED ON 17MAR2022, THE PROBE HAD GIVEN INCORRECT READING .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13967249 ↗
• MalfunctionMar 20, 2022Restricted Flow rate; Failure to Pump; Restricted Flow rate; Failure to Pump

  IT WAS REPORTED THAT THE ARCTIC SUN DEVICE HAD NO FLOW. PER FOLLOW UP INFORMATION RECEIVED ON 14MAR2022, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13835668 ↗
• MalfunctionMar 18, 2022Failure to Pump; Device Sensing Problem; Failure to Pump; Device Sensing Problem

  IT WAS REPORTED THAT THE ARCTIC SUN DEVICE HAD AN ALERT 113 (REDUCED WATER TEMPERATURE CONTROL). PER FOLLOW UP INFORMATION ON (B)(6) 2022, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13814490 ↗
• MalfunctionMar 17, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT AFTER DRAINING THE ARCTIC SUN DEVICE DURING ONSITE MAINTENANCE, LEVEL SENSOR SHOWED 1 BAR AND SHOWED THAT IT WAS NOT EMPTY. BIOMED STATED THAT THE TANK CONTENT WAS VERY SLIMY. LEVEL SENSOR WAS REPLACED, CLEANED, INSTALLED AGAIN AND THE TANK WAS SPLASHED. THIS FIXED THE ISSUE WITH THE WATER LEVEL. PER FOLLOW UP INFORMATION RECEIVED 25FEB2022, IT WAS STATED THAT THE ISSUE WAS RESOLVED BY TECHNICIAN, LEVEL SENSOR AND TANK WERE REMOVED AND CLEANED TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13796138 ↗
• MalfunctionMar 14, 2022Insufficient Cooling; Failure to Pump; Insufficient Cooling; Failure to Pump

  IT WAS REPORTED THAT THE BIOMED HAD AN ARCTIC SUN DEVICE IN WHICH WATER TEMPERATURE DID NOT DECREASE. IT WAS DETECTED IN A PRE-USE TEST ON THE PATIENT. PER FOLLOW UP INFORMATION RECEIVED ON 15MAR2022, THERE WAS NO PATIENT INVOLVEMENT. SYMPTOMS WERE DETECTED DURING THE EQUIPMENT INSPECTION. IT WAS STATED THAT THE MIXING PUMP ASSEMBLY HAS BEEN REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13760212 ↗
• MalfunctionSep 24, 2021Material Fragmentation; Defective Component; Material Fragmentation; Defective Component

  IT WAS REPORTED THAT IN THE ARCTIC SUN DEVICE, THE CONNECTION TO DISPLAY TEMPERATURE ON AN EXTERNAL DEVICE WAS BROKEN, AND THIS ISSUE WAS CONFIRMED BY USING MULTIPLE WORKING CABLES. PER FOLLOW UP INFORMATION RECEIVED ON 02/09/2021, PORT WAS BROKEN AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12525638 ↗
• MalfunctionSep 2, 2021Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE ARCTIC SUN DEVICE HAD TEMPERATURE CORRESPONDING PROBLEMS. PROBABLY THE CABLE HAD A LOOSE CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12415233 ↗