Use caution Medical device recall · FDA · Published December 22, 2022

Maquet Vasoshield Syringe Packs Model VH-5001: Ink Chip Risk

Maquet recalls Vasoshield syringe packs with model VH-5001 due to potential ink chip causing patient harm. Affected units have specific serial numbers and UDI-DI codes.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0996-2023Medical device Maquet ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmMaquet Cardiovascular, LLC45 Barbour Pond Dr · Wayne, NJ 07470-2094

✎ GovInfoNow plain-language explainer

Maquet is recalling Vasoshield syringe packs model VH-5001 because ink on the Maquet logo may chip, risking patient harm like foreign body reactions or embolic events. This is a serious issue for medical use where precise injections are critical. Read more at govinfonow.com/recall/59068-maquet-vasoshield-syringe-packs-model-vh-5001-ink-chip-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/59068-maquet-vasoshield-syringe-packs-model-vh-5001-ink-chip-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0996-2023

Cite this page

“Maquet Vasoshield Syringe Packs Model VH-5001: Ink Chip Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59068-maquet-vasoshield-syringe-packs-model-vh-5001-ink-chip-risk. Based on FDA recall #Z-0996-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0996-2023%22&limit=1).

The FDA announced on Dec. 22, 2022, that Maquet Cardiovascular, LLC is recalling Vasoshield Syringe Packs, Model VH-5001, due to an ink chipping hazard. The agency stated the Maquet logo ink may chip, posing a risk of foreign body reactions and embolic events to patients.

How to tell if you have it

Brand: Maquet
Product: Vasoshield Syringe Packs
Model: VH-5001
UDI-DI: 00607567700468
Serial Numbers: 25147126, 25151632, 25152389, 25152964, 25163138, 25162077
Distribution: US Nationwide, Japan, Germany

The hazard

According to the FDA, ink on the Vasoshield syringe Maquet logo may chip, resulting in an unreasonable risk of harm to the patient. Potential harms include foreign body reaction, coronary embolic event, and peripheral embolic event.

Context

GovInfoNow's records show Maquet Cardiovascular, LLC has 25 other recalls on record since Jan. 24, 2019. Recent similar recalls include the Maquet Vasoview Hemopro 2 Gamma Sterilization Issue (June 2, 2026), the Maquet Heartstring III Proximal Seal System Recall (Aug. 15, 2025), and the Maquet Vasoview Hemopro 3 Endoscopic Vessel Harvesting System Recall (Aug. 6, 2025). Other recent recalls of similar products include the Maquet Percutaneous Insertion Kit (PIK) L Model 701054427 Sterile Packaging Risk (July 31, 2026) and AVID Medical Halyard Kits Recalls regarding particulates risk (April 30, 2026).

How to tell if you have this one

Check for model VH-5001 syringes with serial numbers: 25147126, 25151632, 25152389, 25152964, 25163138, or 25162077. The UDI-DI code 00607567700468 also identifies these units.

Brand
Maquet
Category
Medical device

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
US Nationwide. Japan, Germany.

Recall number	Product, codes & lots	Quantity
Z-0995-2023	Hemopro 2 with Vasoshield, Model VH-4001; UDI-DI: 00607567700901; Serial Numbers: 25152107, 25152204, 25152293, 25152463, 25152771, 25153153, 25153273, 25153366, 25153585, 25153847, 25153960, 25154066, 25154880, 25155262, 25155326, 25155785, 25156245, 25156642, 25157016, 25157085, 25157244, 25157700, 25157898, 25158066, 25158152, 25158374, 25158822, 25158965, 25159100, 25159335, 25159572, 25159695, 25159791, 25160255, 25160398, 25160498, 25160712, 25160961, 25161193, 25161423, 25161672, 25162202, 25162407, 25162505, 25163168, 25163281, 25163367, 3000236928, 3000251969	9817 devices
Z-0996-2023	Vasoshield Syringe Packs, Model VH-5001; UDI-DI: 00607567700468; Serial Numbers: 25147126, 25151632, 25152389, 25152964, 25163138, 25162077	530 units US, 215 units OUS

Based on the official FDA remedy

What to do — step by step

Check Syringe Model
Verify the syringe model is VH-5001 and matches the listed serial numbers or UDI-DI code.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “US Nationwide. Japan, Germany.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 34 days after the firm started it.

Dec 22, 2022Firm started the recall
Jan 19, 2023FDA classified it Class II
Jan 25, 2023Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/59068-maquet-vasoshield-syringe-packs-model-vh-5001-ink-chip-risk">Maquet Vasoshield Syringe Packs Model VH-5001: Ink Chip Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0996-2023 (December 22, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0996-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.