Agency classClass IIOur severity:High FDA (Devices)·Z-2588-2025·Announced 2025-09-24

Heartstring III 4.3 mm seal systems recalled over loading and deployment failures

Heartstring III Proximal Seal Systems, 4.3 mm, are recalled after three failure modes were identified, including failure of the deployed seal to provide adequate hemostasis. 12,471 units are affected.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; failure to achieve hemostasis during aortic surgery is a potential harm and no injuries are reported.

Plain-English summary

The Heartstring III Proximal Seal System, 4.3 mm, an intravascular anastomosis occluder, model HSK-3043, UDI 00607567700321, is being recalled. Affected serial numbers include 3000379223, 3000382433, 3000385929, 3000391405 and 3000399719, with the full list in the recall notice. The recall covers 12,471 units, of which 6,565 are in the United States and 5,906 outside it.

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. The FDA classified the action as Class II.

Hospitals and cardiac surgery units holding affected serial numbers should quarantine them and follow the manufacturer's instructions for return or replacement.

The recalled product

Product: Heartstring III Proximal Seal System, 4.3 MM. Intravascular anastomosis occluder.
Manufacturer: Maquet Cardiovascular, LLC
Category: Medical Device — Cardiac Surgery
Hazard: deployment-failure
hemostasis
vascular-occluder
class-ii

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Model No. HSK-3043
UDI: 00607567700321
Serial No. 3000379223
3000382433
3000385929
3000391405
3000399719
3000404541
3000406469
3000408189
3000411816
3000414253
3000414613
3000415212
3000419765
3000421682
3000422957
3000427645
3000428019
3000429074

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Maquet Cardiovascular, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · Maquet Cardiovascular, LLC

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