COM.TEC 9008031Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04086000860154), received between Jun 11, 2025 and Jul 1, 2026 — classified as 3 injuries.

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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 1, 2026Appropriate Device Problem Term/Code Not Available

  THIS INCIDENT IS RELATED TO THE SAME PATIENT REPORTED IN MDR 3004548776-2026-00296. ON (B)(6) 2026, 02:30 PM FOLLOWING COMPLETE CLINICAL STABILIZATION, TPE WAS RE-ATTEMPTED. TO EVALUATE THE POSSIBILITY OF ALBUMIN-RELATED HYPERSENSITIVITY, FRESH FROZEN PLASMA (FFP) WAS USED AS REPLACEMENT FLUID INSTEAD OF ALBUMIN. APPROXIMATELY 20 MINUTES AFTER INITIATION OF THE PROCEDURE, AFTER TRANSFUSION OF ONE FFP UNIT AND DURING ADMINISTRATION OF THE SECOND FFP UNIT, THE PATIENT AGAIN DEVELOPED A SEVERE HYPERSENSITIVITY REACTION WITH CUTANEOUS MANIFESTATIONS AND SIGNIFICANT HYPOTENSION. THE PROCEDURE WAS IMMEDIATELY DISCONTINUED, AND APPROPRIATE EMERGENCY MANAGEMENT WAS INSTITUTED. PRIOR TO THE SECOND TPE PROCEDURE, THE PATIENT RECEIVED A SLOW TRIAL INFUSION OF ALBUMIN FROM AN ALTERNATIVE MANUFACTURER WITHOUT ANY ADVERSE REACTION. A SEPARATE FFP EXPOSURE OUTSIDE THE TPE PROCEDURE RESULTED ONLY IN A MILD DELAYED RASH OVER THE THIGH APPROXIMATELY TWO HOURS LATER, WITHOUT RESPIRATORY COMPROMISE OR HEMODYNAMIC INSTABILITY.

  Patient problems: Hypersensitivity/Allergic reaction; Low Blood Pressure/ Hypotension

  MAUDE report 25679332 ↗
• InjuryJul 1, 2026Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2026, 10:00 AM, A THERAPEUTIC PLASMA EXCHANGE WAS INITIATED USING THE COM.TEC SYSTEM WITH 5% ALBUMIN (PLASMAGEN®) AS REPLACEMENT FLUID. APPROXIMATELY 15 MINUTES AFTER INITIATION OF THE PROCEDURE, THE PATIENT DEVELOPED A SEVERE HYPERSENSITIVITY/ANAPHYLACTOID REACTION CHARACTERIZED BY WHEEZING, STRIDOR, OXYGEN DESATURATION, GENERALIZED URTICARIA/HIVES, FLUSHING, FACIAL PUFFINESS, TACHYCARDIA, AND SEVERE HYPOTENSION (BLOOD PRESSURE DECREASED FROM APPROXIMATELY 140/90 MMHG TO 80/60 MMHG). THE PROCEDURE WAS IMMEDIATELY DISCONTINUED. THE PATIENT WAS TREATED WITH ADRENALINE 0.1 MG, HYDROCORTISONE 100 MG IV, PHENIRAMINE MALEATE (AVIL®) 1 AMPOULE IV AND GELOFUSINE® 500 ML BOLUS. SUPPLEMENTAL OXYGEN VIA FACE MASK. THE PATIENT SUBSEQUENTLY STABILIZED.

  Patient problems: Anaphylactic Shock; Low Oxygen Saturation; Tachycardia; Wheezing

  MAUDE report 25679331 ↗
• InjuryJun 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO SAMPLE OR PICTURE WERE AVAILABLE FOR ANALYSIS. WITHOUT THE PROPER SAMPLE OR PICTURE EVALUATION IS NOT POSSIBLE TO DETERMINE THE PROBABLE ROOT CAUSE OF THE REPORTED FAILURE. THE CUSTOMER COMPLAINT IS NOT CONFIRMED. ROOT CAUSE CANNOT BE IDENTIFIED BASED ON THE KIT AUTOPSY, AS THERE IS NO SAMPLE OR PICTURE AVAILABLE FOR EVALUATION. THE BATCH RECORD WAS REVIEWED, AND NO EXCEPTIONS WERE GENERATED THAT COULD CLASSIFY AS A POSSIBLE ROOT CAUSE OF THIS DEFECT. THE FINISHED GOOD LOT HAS PASSED ALL SAMPLING ACCEPTANCE CRITERIA FOR ALL TESTS PERFORMED INCLUDING IN-PROCESS AND PRODUCT TESTING.

  Patient problems: Anaphylactic Shock

  MAUDE report 22189119 ↗