HIGH

Maquet Cardiovascular Recalls 16,512 Heartstring III Seal Systems Over Hemostasis Failure

Maquet Cardiovascular recalled 16,512 Heartstring III Proximal Seal Systems due to three identified failure modes. The device may fail to load, deploy, or provide adequate hemostasis during use. Healthcare providers must stop using the device immediately and contact the manufacturer for guidance.

Quick Facts at a Glance

Recall Date
August 15, 2025
Hazard Level
HIGH
Brand
Maquet Cardiovascular
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Maquet Cardiovascular, LLC or your healthcare provider for instructions. Notification method: Letter

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About This Product

The Heartstring III Proximal Seal System is used in surgeries involving intravascular anastomosis to provide occlusion. It is designed to help facilitate blood flow management during surgical procedures under specific conditions.

Why This Is Dangerous

The device may fail to load or deploy properly, compromising hemostasis. This could lead to uncontrolled bleeding or other serious complications during surgery.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Patients and healthcare providers must stop using the device to avoid serious surgical complications. This recall significantly impacts surgical procedures and patient safety.

Practical Guidance

How to identify if yours is affected

  1. Check the model number and serial numbers against the recall announcement.
  2. Identify where the device is stored and ensure it is no longer accessible for use.
  3. Contact your healthcare provider to confirm if your specific device is affected.

Where to find product info

Model and serial numbers can typically be found on the device packaging or printed directly on the device body.

What timeline to expect

Expect a few weeks for the processing of returns and refunds.

If the manufacturer is unresponsive

  • Follow up via email or phone with the manufacturer.
  • Contact your healthcare provider for assistance.

How to prevent similar issues

  • Look for devices that comply with current safety standards from recognized agencies.
  • Consult healthcare professionals regarding the latest and safest devices for surgical procedures.

Documentation advice

Keep records of communication regarding the recall, including emails, letters, and any return shipping receipts.

Product Details

Model No. HSK-3043. UDI: 00607567700321. Serial Numbers: 3000379223, 3000382433, 3000385929, 3000391405, 3000399719, 3000404541, 3000406469, 3000408189, 3000411816, 3000414253, 3000414613, 3000415212, 3000419765, 3000421682, 3000422957, 3000427645, 3000428019, 3000429074. Distributed worldwide, including the US, Australia, Canada, and several European countries.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 16,512 units recalled
  • Model No. HSK-3043
  • UDI: 00607567700321
  • Multiple serial numbers affected
  • Distribution includes US and 26 other countries
  • Follow the manufacturer's recall instructions
View Original Recall on FDA - Medical Devices

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Safety Guide

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeIntravascular Anastomosis Occluder
Sold At
Multiple Retailers

Product Details

Model Numbers
Model No. HSK-3043
UDI: 00607567700321
Serial No. 3000379223
3000382433
3000385929
+15 more
Affected States
ALL
Report Date
September 24, 2025
Recall Status
ACTIVE

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