Vasoshield VH-5001Recalls & reported problems
Maquet Cardiovascular LLC · Vasoshield Pressure Controlling Syringe · Class 1
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
The Vasoshield pressure controlling syringe is used to hold pressure while a surgeon harvests blood vessels. Most of the 27 reports describe the syringe not building pressure during vein harvesting, so vessels did not swell and the procedure had to be stopped or a different syringe used; a few also mention short shelf life and ink that could chip off. No deaths and no injuries are reported. One recall, started in December 2022 and still open, concerns that chipping ink on the Maquet logo.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 27
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00607567700468), received between Aug 2, 2022 and Jul 18, 2024 — classified as 27 malfunctions.
The most frequently reported specific device problem is “Improper Flow or Infusion” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Dec 22, 2022Open, Classified
Ink on the Vasoshield syringe Maquet logo may chip resulting in an unreasonable risk of harm to the patient. Potential harms may include foreign body reaction, coronary embolic event, and peripheral embolic event.
Z-0996-2023 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- No Apparent Adverse Event25
- Improper Flow or Infusion1
- Inflation Problem1
- No Pressure1
Patient problems
- No Clinical Signs, Symptoms or Conditions27
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 18, 2024No Pressure; No Pressure
THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOSHIELD PRESSURE CONTROLLING SYRINGE HAD NO PRESSURE. THEY USED IT WITH A SETTING OF 250MMHG, BUT SINCE NO PRESSURE WAS APPLIED, THEY CHANGED THE SETTING TO 350MMHG AND USED IT, BUT STILL NO PRESSURE WAS APPLIED. THE CONTAINER WAS FILLED WITH WATER AND INSPECTED FOR LEAKS. AS A RESULT, THE BLOOD VESSELS DID NOT SWELL AND ITS USE WAS DISCONTINUED. NO MEDICAL/SURGICAL INTERVENTION WAS NECESSARY. THEY STOPPED USING VH-5001 AND USED A REGULAR SYRINGE. THERE WERE NO DELAYS IN THE PROCESS. THERE WERE NO EFFECTS ON PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19773535 ↗MalfunctionMay 17, 2024Inflation Problem; Improper Flow or Infusion; Inflation Problem; Improper Flow or Infusion
THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VESSEL HARVESTING PROCEDURE, VASOSHIELD PRESSURE CONTROLLING SYRINGE SET AT A PRESSURE OF 250 DID NOT CAUSE BLOOD VESSELS TO SWELL. A NEW DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 19340595 ↗MalfunctionAug 3, 2022No Apparent Adverse Event; No Apparent Adverse Event
RELATED TO: (B)(4). SSU GERMANY REPORTED CUSTOMER COMPLAINS THAT THE SHELF LIFE OF THE DELIVERY OF 5 PACKS OF CVH-5001 VASOSHIELD PRESSURE CONTROLLING SYRINGE / IS TOO SHORT < 12 MONTHS. A MAXIMUM USAGE TIME OF 13 WEEKS AFTER DELIVERY IS TOO SHORT. DEVICES WERE WITHDRAWN FROM CIRCULATION AT THE END OF THE PERIOD OF USE - THEREFORE NO USE ON PATIENTS, NO IMPAIRMENT AND/OR DAMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15155525 ↗MalfunctionAug 2, 2022No Apparent Adverse Event; No Apparent Adverse Event
RELATED TO (B)(4). SSU (B)(6) REPORTED CUSTOMER COMPLAINS THAT THE SHELF LIFE OF THE DELIVERY OF 5 PACKS OF CVH-5001 VASOSHIELD PRESSURE CONTROLLING SYRINGE / IS TOO SHORT < 12 MONTHS. A MAXIMUM USAGE TIME OF 13 WEEKS AFTER DELIVERY IS TOO SHORT. DEVICES WERE WITHDRAWN FROM CIRCULATION AT THE END OF THE PERIOD OF USE - THEREFORE NO USE ON PATIENTS, NO IMPAIRMENT AND/OR DAMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15153819 ↗MalfunctionAug 2, 2022No Apparent Adverse Event; No Apparent Adverse Event
RELATED TO (B)(4). SSU (B)(6) REPORTED CUSTOMER COMPLAINS THAT THE SHELF LIFE OF THE DELIVERY OF 5 PACKS OF CVH-5001 VASOSHIELD PRESSURE CONTROLLING SYRINGE / IS TOO SHORT < 12 MONTHS. A MAXIMUM USAGE TIME OF 13 WEEKS AFTER DELIVERY IS TOO SHORT. DEVICES WERE WITHDRAWN FROM CIRCULATION AT THE END OF THE PERIOD OF USE - THEREFORE NO USE ON PATIENTS, NO IMPAIRMENT AND/OR DAMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15153785 ↗MalfunctionAug 2, 2022No Apparent Adverse Event; No Apparent Adverse Event
RELATED TO (B)(4). SSU (B)(6) REPORTED CUSTOMER COMPLAINS THAT THE SHELF LIFE OF THE DELIVERY OF 5 PACKS OF CVH-5001 VASOSHIELD PRESSURE CONTROLLING SYRINGE / IS TOO SHORT < 12 MONTHS. A MAXIMUM USAGE TIME OF 13 WEEKS AFTER DELIVERY IS TOO SHORT. DEVICES WERE WITHDRAWN FROM CIRCULATION AT THE END OF THE PERIOD OF USE - THEREFORE NO USE ON PATIENTS, NO IMPAIRMENT AND/OR DAMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15153764 ↗MalfunctionAug 2, 2022No Apparent Adverse Event; No Apparent Adverse Event
RELATED TO (B)(4). SSU GERMANY REPORTED CUSTOMER COMPLAINS THAT THE SHELF LIFE OF THE DELIVERY OF 5 PACKS OF CVH-5001 VASOSHIELD PRESSURE CONTROLLING SYRINGE / IS TOO SHORT < 12 MONTHS. A MAXIMUM USAGE TIME OF 13 WEEKS AFTER DELIVERY IS TOO SHORT. DEVICES WERE WITHDRAWN FROM CIRCULATION AT THE END OF THE PERIOD OF USE - THEREFORE NO USE ON PATIENTS, NO IMPAIRMENT AND/OR DAMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15153721 ↗MalfunctionAug 2, 2022No Apparent Adverse Event; No Apparent Adverse Event
RELATED TO: (B)(4). SSU GERMANY REPORTED CUSTOMER COMPLAINS THAT THE SHELF LIFE OF THE DELIVERY OF 5 PACKS OF CVH-5001 VASOSHIELD PRESSURE CONTROLLING SYRINGE / IS TOO SHORT < 12 MONTHS. A MAXIMUM USAGE TIME OF 13 WEEKS AFTER DELIVERY IS TOO SHORT. DEVICES WERE WITHDRAWN FROM CIRCULATION AT THE END OF THE PERIOD OF USE - THEREFORE NO USE ON PATIENTS, NO IMPAIRMENT AND/OR DAMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15153720 ↗MalfunctionAug 2, 2022No Apparent Adverse Event; No Apparent Adverse Event
RELATED TO (B)(4). SSU (B)(6) REPORTED CUSTOMER COMPLAINS THAT THE SHELF LIFE OF THE DELIVERY OF 5 PACKS OF CVH-5001 VASOSHIELD PRESSURE CONTROLLING SYRINGE / IS TOO SHORT < 12 MONTHS. A MAXIMUM USAGE TIME OF 13 WEEKS AFTER DELIVERY IS TOO SHORT. DEVICES WERE WITHDRAWN FROM CIRCULATION AT THE END OF THE PERIOD OF USE - THEREFORE NO USE ON PATIENTS, NO IMPAIRMENT AND/OR DAMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15153711 ↗MalfunctionAug 2, 2022No Apparent Adverse Event; No Apparent Adverse Event
RELATED TO: (B)(4). SSU GERMANY REPORTED CUSTOMER COMPLAINS THAT THE SHELF LIFE OF THE DELIVERY OF 5 PACKS OF CVH-5001 VASOSHIELD PRESSURE CONTROLLING SYRINGE / IS TOO SHORT < 12 MONTHS. A MAXIMUM USAGE TIME OF 13 WEEKS AFTER DELIVERY IS TOO SHORT. DEVICES WERE WITHDRAWN FROM CIRCULATION AT THE END OF THE PERIOD OF USE - THEREFORE NO USE ON PATIENTS, NO IMPAIRMENT AND/OR DAMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15153709 ↗MalfunctionAug 2, 2022No Apparent Adverse Event; No Apparent Adverse Event
RELATED TO (B)(4). SUMMARY: SSU (B)(6) REPORTED CUSTOMER COMPLAINS THAT THE SHELF LIFE OF THE DELIVERY OF 5 PACKS OF CVH-5001 VASOSHIELD PRESSURE CONTROLLING SYRINGE / IS TOO SHORT < 12 MONTHS. A MAXIMUM USAGE TIME OF 13 WEEKS AFTER DELIVERY IS TOO SHORT. DEVICES WERE WITHDRAWN FROM CIRCULATION AT THE END OF THE PERIOD OF USE - THEREFORE NO USE ON PATIENTS, NO IMPAIRMENT AND/OR DAMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15153706 ↗MalfunctionAug 2, 2022No Apparent Adverse Event; No Apparent Adverse Event
RELATED TO (B)(4). SSU GERMANY REPORTED CUSTOMER COMPLAINS THAT THE SHELF LIFE OF THE DELIVERY OF 5 PACKS OF CVH-5001 VASOSHIELD PRESSURE CONTROLLING SYRINGE / IS TOO SHORT < 12 MONTHS. A MAXIMUM USAGE TIME OF 13 WEEKS AFTER DELIVERY IS TOO SHORT. DEVICES WERE WITHDRAWN FROM CIRCULATION AT THE END OF THE PERIOD OF USE - THEREFORE NO USE ON PATIENTS, NO IMPAIRMENT AND/OR DAMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15153700 ↗MalfunctionAug 2, 2022No Apparent Adverse Event; No Apparent Adverse Event
RELATED TO (B)(4). SSU (B)(6) REPORTED CUSTOMER COMPLAINS THAT THE SHELF LIFE OF THE DELIVERY OF 5 PACKS OF CVH-5001 VASOSHIELD PRESSURE CONTROLLING SYRINGE / IS TOO SHORT < 12 MONTHS. A MAXIMUM USAGE TIME OF 13 WEEKS AFTER DELIVERY IS TOO SHORT. DEVICES WERE WITHDRAWN FROM CIRCULATION AT THE END OF THE PERIOD OF USE - THEREFORE NO USE ON PATIENTS, NO IMPAIRMENT AND/OR DAMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15153695 ↗MalfunctionAug 2, 2022No Apparent Adverse Event; No Apparent Adverse Event
RELATED TO (B)(4). SSU (B)(6) REPORTED CUSTOMER COMPLAINS THAT THE SHELF LIFE OF THE DELIVERY OF 5 PACKS OF CVH-5001 VASOSHIELD PRESSURE CONTROLLING SYRINGE / IS TOO SHORT < 12 MONTHS. A MAXIMUM USAGE TIME OF 13 WEEKS AFTER DELIVERY IS TOO SHORT. DEVICES WERE WITHDRAWN FROM CIRCULATION AT THE END OF THE PERIOD OF USE - THEREFORE NO USE ON PATIENTS, NO IMPAIRMENT AND/OR DAMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15153649 ↗MalfunctionAug 2, 2022No Apparent Adverse Event; No Apparent Adverse Event
RELATED TO (B)(4). SUMMARY: SSU (B)(6) REPORTED CUSTOMER COMPLAINS THAT THE SHELF LIFE OF THE DELIVERY OF 5 PACKS OF CVH-5001 VASOSHIELD PRESSURE CONTROLLING SYRINGE / IS TOO SHORT < 12 MONTHS. A MAXIMUM USAGE TIME OF 13 WEEKS AFTER DELIVERY IS TOO SHORT. DEVICES WERE WITHDRAWN FROM CIRCULATION AT THE END OF THE PERIOD OF USE - THEREFORE NO USE ON PATIENTS, NO IMPAIRMENT AND/OR DAMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15153648 ↗MalfunctionAug 2, 2022No Apparent Adverse Event; No Apparent Adverse Event
RELATED TO (B)(4). SSU GERMANY REPORTED CUSTOMER COMPLAINS THAT THE SHELF LIFE OF THE DELIVERY OF 5 PACKS OF CVH-5001 VASOSHIELD PRESSURE CONTROLLING SYRINGE / IS TOO SHORT < 12 MONTHS. A MAXIMUM USAGE TIME OF 13 WEEKS AFTER DELIVERY IS TOO SHORT. DEVICES WERE WITHDRAWN FROM CIRCULATION AT THE END OF THE PERIOD OF USE - THEREFORE NO USE ON PATIENTS, NO IMPAIRMENT AND/OR DAMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15153644 ↗MalfunctionAug 2, 2022No Apparent Adverse Event; No Apparent Adverse Event
RELATED TO (B)(4). SSU (B)(6) REPORTED CUSTOMER COMPLAINS THAT THE SHELF LIFE OF THE DELIVERY OF 5 PACKS OF CVH-5001 VASOSHIELD PRESSURE CONTROLLING SYRINGE / IS TOO SHORT < 12 MONTHS. A MAXIMUM USAGE TIME OF 13 WEEKS AFTER DELIVERY IS TOO SHORT. DEVICES WERE WITHDRAWN FROM CIRCULATION AT THE END OF THE PERIOD OF USE - THEREFORE NO USE ON PATIENTS, NO IMPAIRMENT AND/OR DAMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15153629 ↗MalfunctionAug 2, 2022No Apparent Adverse Event; No Apparent Adverse Event
RELATED TO (B)(4). SSU (B)(6) REPORTED CUSTOMER COMPLAINS THAT THE SHELF LIFE OF THE DELIVERY OF 5 PACKS OF CVH-5001 VASOSHIELD PRESSURE CONTROLLING SYRINGE / IS TOO SHORT < 12 MONTHS. A MAXIMUM USAGE TIME OF 13 WEEKS AFTER DELIVERY IS TOO SHORT. DEVICES WERE WITHDRAWN FROM CIRCULATION AT THE END OF THE PERIOD OF USE - THEREFORE NO USE ON PATIENTS, NO IMPAIRMENT AND/OR DAMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15153602 ↗MalfunctionAug 2, 2022No Apparent Adverse Event; No Apparent Adverse Event
RELATED TO (B)(4). SSU (B)(4) REPORTED CUSTOMER COMPLAINS THAT THE SHELF LIFE OF THE DELIVERY OF 5 PACKS OF CVH-5001 VASOSHIELD PRESSURE CONTROLLING SYRINGE / IS TOO SHORT < 12 MONTHS. A MAXIMUM USAGE TIME OF 13 WEEKS AFTER DELIVERY IS TOO SHORT. DEVICES WERE WITHDRAWN FROM CIRCULATION AT THE END OF THE PERIOD OF USE - THEREFORE NO USE ON PATIENTS, NO IMPAIRMENT AND/OR DAMAGE..
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15153601 ↗MalfunctionAug 2, 2022No Apparent Adverse Event; No Apparent Adverse Event
RELATED TO (B)(4). SSU (B)(6) REPORTED CUSTOMER COMPLAINS THAT THE SHELF LIFE OF THE DELIVERY OF 5 PACKS OF CVH-5001 VASOSHIELD PRESSURE CONTROLLING SYRINGE / IS TOO SHORT < 12 MONTHS. A MAXIMUM USAGE TIME OF 13 WEEKS AFTER DELIVERY IS TOO SHORT. DEVICES WERE WITHDRAWN FROM CIRCULATION AT THE END OF THE PERIOD OF USE - THEREFORE NO USE ON PATIENTS, NO IMPAIRMENT AND/OR DAMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15153591 ↗MalfunctionAug 2, 2022No Apparent Adverse Event; No Apparent Adverse Event
RELATED TO (B)(4). SUMMARY: SSU (B)(6) REPORTED CUSTOMER COMPLAINS THAT THE SHELF LIFE OF THE DELIVERY OF 5 PACKS OF CVH-5001 VASOSHIELD PRESSURE CONTROLLING SYRINGE / IS TOO SHORT < 12 MONTHS. A MAXIMUM USAGE TIME OF 13 WEEKS AFTER DELIVERY IS TOO SHORT. DEVICES WERE WITHDRAWN FROM CIRCULATION AT THE END OF THE PERIOD OF USE - THEREFORE NO USE ON PATIENTS, NO IMPAIRMENT AND/OR DAMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15153586 ↗MalfunctionAug 2, 2022No Apparent Adverse Event; No Apparent Adverse Event
RELATED TO (B)(4). SSU (B)(6) REPORTED CUSTOMER COMPLAINS THAT THE SHELF LIFE OF THE DELIVERY OF 5 PACKS OF CVH-5001 VASOSHIELD PRESSURE CONTROLLING SYRINGE / IS TOO SHORT < 12 MONTHS. A MAXIMUM USAGE TIME OF 13 WEEKS AFTER DELIVERY IS TOO SHORT. DEVICES WERE WITHDRAWN FROM CIRCULATION AT THE END OF THE PERIOD OF USE - THEREFORE NO USE ON PATIENTS, NO IMPAIRMENT AND/OR DAMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15153544 ↗MalfunctionAug 2, 2022No Apparent Adverse Event; No Apparent Adverse Event
RELATED TO (B)(4). SSU GERMANY REPORTED CUSTOMER COMPLAINS THAT THE SHELF LIFE OF THE DELIVERY OF 5 PACKS OF CVH-5001 VASOSHIELD PRESSURE CONTROLLING SYRINGE / IS TOO SHORT < 12 MONTHS. A MAXIMUM USAGE TIME OF 13 WEEKS AFTER DELIVERY IS TOO SHORT. DEVICES WERE WITHDRAWN FROM CIRCULATION AT THE END OF THE PERIOD OF USE - THEREFORE NO USE ON PATIENTS, NO IMPAIRMENT AND/OR DAMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15153534 ↗MalfunctionAug 2, 2022No Apparent Adverse Event; No Apparent Adverse Event
RELATED TO (B)(4). SSU (B)(6) REPORTED CUSTOMER COMPLAINS THAT THE SHELF LIFE OF THE DELIVERY OF 5 PACKS OF CVH-5001 VASOSHIELD PRESSURE CONTROLLING SYRINGE / IS TOO SHORT < 12 MONTHS. A MAXIMUM USAGE TIME OF 13 WEEKS AFTER DELIVERY IS TOO SHORT. DEVICES WERE WITHDRAWN FROM CIRCULATION AT THE END OF THE PERIOD OF USE - THEREFORE NO USE ON PATIENTS, NO IMPAIRMENT AND/OR DAMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15153513 ↗MalfunctionAug 2, 2022No Apparent Adverse Event; No Apparent Adverse Event
RELATED TO (B)(4). SSU (B)(6) REPORTED CUSTOMER COMPLAINS THAT THE SHELF LIFE OF THE DELIVERY OF 5 PACKS OF CVH-5001 VASOSHIELD PRESSURE CONTROLLING SYRINGE / IS TOO SHORT < 12 MONTHS. A MAXIMUM USAGE TIME OF 13 WEEKS AFTER DELIVERY IS TOO SHORT. DEVICES WERE WITHDRAWN FROM CIRCULATION AT THE END OF THE PERIOD OF USE - THEREFORE NO USE ON PATIENTS, NO IMPAIRMENT AND/OR DAMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15153490 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.