Control Syringe 193210Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00886333207213), received between Jan 18, 2022 and Jun 21, 2024 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Air/Gas in Device” (2 reports).

3 other recalls cover devices cleared under the same FDA submission (K911732); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionJun 21, 2024Gas/Air Leak; Gas/Air Leak

  MULTIPLE ISSUES REPORTED OF 12CC SYRINGE DRAWING IN AIR DURING MANIFOLD PREP.

  Patient problems: Insufficient Information

  MAUDE report 19580939 ↗
• MalfunctionApr 18, 2023Air/Gas in Device; Air/Gas in Device

  SYRINGE CONNECTION TO MEDLINE MANIFOLD WAS ALLOWING AIR TO BE ENTRAPPED IN THE SYSTEM ¿ HENCE, POTENTIAL FOR AIR EMBOLUS HIGH. ANOTHER 12CC ARGON SYRINGE WAS OPENED WHICH HAD NO ISSUES. MEDLINE MANIFOLD WAS USED DURING THE TIME OF EVENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16761726 ↗
• InjuryMar 8, 2023Fluid/Blood Leak; Air/Gas in Device; Fluid/Blood Leak; Air/Gas in Device

  POTENTIAL SERIOUS ADVERSE EVENT OCCURRED DURING PATIENT USE ¿ APPROXIMATELY WITHIN 10 MINUTES OF PRODUCT USE. PATIENT INJURY REPORTED: SEVERE TRANSIENT HYPOTENSION, CHEST PAIN, AND ST ELEVATION MEDICAL INTERVENTION: APPLICATION OF OXYGEN THERAPY, IV FLUID BOLUS, ADMINISTRATION OF NARCOTIC DURING AN ANGIOGRAM PROCEDURE, SCRUB RN INFORMED MD THAT THERE WAS AIR/BUBBLES IN THE CONTRAST INJECTOR SYRINGE WHILE PULLING CONTRAST WHEN CONNECTED TO THE MANIFOLD. NEXT, INVESTIGATED CONNECTIONS BETWEEN THE CONTRAST BOTTLE, CONTRAST TUBING, MANIFOLD AND CONTROL SYRINGE. NO AIR NOR BUBBLES PRESENT IN THE LINE FROM CONTRAST BOTTLE TO THE MANIFOLD. ONCE MANIFOLD AND CONTRAST SYRINGE IS CLEARED OF AIR, IF SYSTEM REMAINS CLOSED, THERE SHOULD BE NO AIR PRESENT. THE SYSTEM WAS CLEARED MULTIPLE TIMES AND CHECKED FOR AIR. NO AIR WAS NOTED. THEREAFTER, DR INSTRUCTED THE SCRUB RN TO INJECT CONTRAST TO VIEW MORE PICTURES AND RIGHT AFTER, AIR WAS INJECTED TO THE PATIENT'S CORONARY ARTERY. AN AIR EMBOLI WAS NOTICED ON X-RAY AND THE PATIENT REPORTED CHEST DISCOMFORT. PATIENT'S HEMODYNAMICS ALSO CHANGED -- ST ELEVATION AND DECREASED BLOOD PRESSURE. APPROPRIATE CARE PROVIDED TO THE PATIENT.

  Patient problems: Low Blood Pressure/ Hypotension; Pain

  MAUDE report 16501963 ↗
• MalfunctionJan 18, 2022Physical Resistance/Sticking

  DURING PROCEDURE, A PHYSICIAN WAS UNABLE TO PUSH/PULL THE PLUNGER DUE TO HIGH RESISTANCE. THE PROCEDURE WAS COMPLETED BY USING AN ADDITIONALLY OPENED REPLACEMENT (193210). AS A RESULT OF THE RETURNED SAMPLE(S) REVIEW AT GMK: THE SYRINGE TIP WAS BLOCKED BY SOMETHING, AND HIGH RESISTANCE TO PULL THE PLUNGER WAS CONFIRMED, BEFORE CLEANING OF THE SAMPLE. IT WAS DISAPPEARED, AFTER CLEANING OF THE SAMPLE.

  Patient problems: Insufficient Information

  MAUDE report 13280659 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K911732. One submission often covers many models, so check the product and lot details in each record.

• Z-1076-05 · Jun 27, 2005 · Terminated
  Product consists of a syringe used to inject fluids during an angiographic procedure for fluoroscopic imaging. Labeling is as follows: Product Label ''***Argon Medical Device***10
• Z-1077-05 · Jun 27, 2005 · Terminated
  Labeling is as follows: Product Labeling: ''***Argon Medical Devices***CUSTOM MANIFOLD KIT***REF/REORDER NO. 194902A***CONTENTS: 1 3-Port Manifold, 500 PSI***1 ASY CDX3 Transduce
• Z-1078-05 · Jun 27, 2005 · Terminated
  Product consists of a syringe used to inject fluids during an angiographic procedure for fluoroscopic imaging. Labeling is as follows: Product Label ''***Argon Medical Device***RE